Xolair

Package leaflet: Information for the user

Xolair 75 mg solution for injection in pre-filled syringe

(pre-filled syringe with attached 26-gauge needle, blue protective cap)
omalizumab
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Xolair is and what it is used for
2. What you need to know before using Xolair
3. How to use Xolair
4. Possible side effects
5. How to store Xolair
6. Contents of the pack and other information

1. What is Xolair and what is it used for?

Xolair contains the active substance omalizumab. Omalizumab is a synthetic protein similar to the
natural proteins produced by the body. It belongs to a class of medicines called monoclonal antibodies.
Xolair is used for the treatment of:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of severe allergic asthma in adults, adolescents, and children (from 6 years of age onwards) who are already receiving asthma medications, but in whom asthma symptoms are not well controlled by medications such as high-dose inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age onwards) who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but in whom symptoms are not well controlled by these medications. Nasal polyps are small growths on the lining of the nose. Xolair helps reduce the size of nasal polyps and improves symptoms, including nasal congestion, loss of smell, mucus in the back of the throat, and runny nose.
Xolair works by blocking a substance known as immunoglobulin E (IgE), which is produced by the body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and chronic rhinosinusitis with nasal polyps.

2. What you need to know before using Xolair

Do not use Xolair

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic to any of the ingredients, inform your doctor, as you must not use Xolair.

Warnings and precautions
Talk to your doctor before using Xolair:

• if you have kidney or liver problems;
• if you have a condition in which your immune system attacks part of your body (autoimmune disease);
• if you plan to travel to areas where parasitic infections are common, as Xolair may reduce your resistance to these infections;
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, following a medicine, an insect sting, or food;
• if you have ever had an allergic reaction to latex. The needle cap of the syringe may contain rubber (latex).

Xolair does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Xolair must not be used to treat these symptoms.
Do not use Xolair to prevent or treat other allergic conditions such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease), food allergy, eczema, or hay fever, as Xolair has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious side effects
Xolair may potentially cause serious side effects. You should be aware of the signs of these conditions while using Xolair. Seek immediate medical help if you notice any signs of a severe allergic reaction or other serious side effects. These signs are listed in section 4 under "Serious side effects".
Before you self-inject Xolair or before someone who is not a healthcare professional administers the injection, it is important that your doctor provides you with instructions on how to recognize early symptoms of severe allergic reactions and how to manage these reactions if they occur (see section 3, "How to use Xolair"). Most severe allergic reactions occur within the first 3 doses of Xolair.
Children and adolescents
Allergic asthma
Xolair is not recommended in children below 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Xolair is not recommended in children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Other medicines and Xolair
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines for the treatment of a parasitic infection, as Xolair may reduce the effectiveness of these medicines;
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will discuss with you the benefits and potential risks of using this medicine during pregnancy.
If you become pregnant while being treated with Xolair, inform your doctor immediately.
Xolair may pass into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.
Driving and using machines
It is unlikely that Xolair will affect your ability to drive or operate machinery.

3. How to use Xolair

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.
How to use Xolair
Xolair is administered as an injection under the skin (known as a subcutaneous injection).
Xolair injection

• You and your doctor will decide whether you can self-inject Xolair. The first 3 doses must always be administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained on how to inject the medicine before administering the injection yourself.
• A person assisting you (for example, a family member) may also administer the Xolair injection after having been adequately trained.

For detailed instructions on how to inject Xolair, read the “Instructions for use of Xolair pre-filled
syringe” at the end of this leaflet.
Instructions on how to recognize severe allergic reactions
It is also important that you do not self-inject Xolair until you have been trained by your doctor
or nurse on:

• how to recognize the early signs and symptoms of severe allergic reactions;
• what to do if symptoms occur. For further information on the early signs and symptoms of severe allergic reactions, see section 4.

Dosage
Your doctor will determine the dose of Xolair you need and how often you should use it. This
depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE levels.
You may need from 1 to 4 injections at a time. You will need injections every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Xolair. Do not stop taking your asthma and/or nasal polyps medication without first consulting your doctor.
You may not notice immediate improvement after starting treatment with Xolair. In patients with nasal polyps, effects become noticeable after 4 weeks of treatment. In patients with asthma, full effect is usually achieved after 12–16 weeks.
Use in children and adolescents
Allergic asthma
Xolair can be used in children and adolescents aged 6 years and older who are already taking asthma medication but whose asthma symptoms are not well controlled with medications such as high-dose inhaled corticosteroids and inhaled beta agonists. Your doctor will determine the amount of Xolair the child needs and how often it should be administered. This will depend on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s IgE levels.
Self-administration of Xolair is not recommended for children (aged 6 to 11 years).
However, if considered appropriate by the doctor, the Xolair injection may be given by a caregiver after receiving adequate training.
Chronic rhinosinusitis with nasal polyps
Xolair must not be used in children and adolescents under 18 years of age.
If you miss a dose of Xolair
If you miss an appointment, contact your doctor or hospital as soon as possible to reschedule.
If you forget to administer a dose of Xolair, inject the missed dose as soon as you remember. Then
contact your doctor to determine when you should receive the next dose.
If you stop treatment with Xolair
Do not stop treatment with Xolair unless instructed by your doctor. Stopping or interrupting treatment with Xolair may cause symptoms to return.
If you have any questions about using this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects caused by Xolair are usually mild or moderate in severity, but occasionally they can be serious.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical help:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea, or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Xolair, you may have an increased risk of developing a severe allergic reaction following use of Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood or lymph vessels, high levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, or tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as increased tendency to bleeding or bruising.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• injection site reactions such as pain, swelling, itching, and redness
• pain in the upper abdomen
• headache (very common in children)
• feeling dizzy
• joint pain (arthralgia)

Uncommon (may affect up to 1 in 100 people)

• feeling sleepy or tired
• tingling or numbness in hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute breathing problems
• feeling unwell (nausea), diarrhoea, indigestion
• itching, hives, rash, increased sensitivity of the skin to sunlight
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known (frequency cannot be estimated from the available data)

• muscle pain and joint swelling
• hair loss

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xolair

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled syringe can be stored for a total period of up to 48 hours at room temperature (25°C). Store in the original packaging to protect the medicine from light. Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use if the packaging is damaged or shows signs of tampering.

6. Package contents and other information

What Xolair contains

• The active substance is omalizumab. One 0.5 mL pre-filled syringe of solution contains 75 mg of omalizumab.
• The other components are arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, and water for injections.
• The needle cap of the syringe may contain dry rubber (latex).

Description of the appearance of Xolair and contents of the pack
Xolair injectable solution is a clear or slightly opalescent solution, colourless to pale yellowish-brown, contained in a pre-filled syringe.
Xolair 75 mg solution for injection in pre-filled syringe with a presoldered 26-gauge needle with blue protective cap is available in packs containing 1 pre-filled syringe and in multiple packs containing 4 (4 x 1) or 10 (10 x 1) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF XOLAIR PREFILLED SYRINGE

Before injecting, read ALL of these instructions completely. If your doctor decides that you or a
caregiver may administer Xolair injections at home, you must be trained by your doctor,
nurse, or pharmacist before you or someone else self-administers the injection.
Children (aged 6 to less than 12 years) should not self-inject Xolair. However, if the
doctor considers it appropriate, a caregiver may administer the Xolair injection
after receiving adequate training. The carton contains a plastic tray with individually sealed
prefilled Xolair syringe(s).
Xolair 75 mg injectable solution in prefilled syringe

Syringe cap Shield Flange Needle shield
observation window
syringe label and expiry date Plunger
Plunger rod

After injecting the medicine, the syringe’s safety shield automatically covers the needle. This is to
protect against accidental needlestick injuries.

What else is needed for the injection:

Alcohol swab.

• Gauze or cotton ball.
• Sharps disposal container.

Important safety information
Warning: Keep the syringe out of the sight and reach of children.

• The needle cap may contain rubber (latex) and must not come into contact with individuals allergic to this substance.
• Do not open the sealed outer carton until the time of use.
• Do not use this medicine if the seal on the carton or the seal on the plastic tray is broken, as use may not be safe.
• Do not use if the syringe has been dropped on a hard surface or has been dropped after removing the needle cap.
• Do not leave the syringe where others may tamper with it.
• Do not shake the syringe.
• Be careful not to touch the safety wings before use. Touching the wings may cause premature activation of the syringe’s safety shield.
• Do not remove the needle cap until the time of injection.
• The syringe is not reusable. Immediately dispose of the used syringe in a sharps disposal container after use.

Storage of Xolair injectable solution in prefilled syringe

• Store the medicine sealed in its carton to protect it from light. Store in
  the refrigerator at 2°C to 8°C. DO NOT FREEZE.

• Remember to remove the syringe from the refrigerator so it can reach room temperature (25°C) before preparing it for injection (this takes about 30 minutes). Leave the syringe in the carton to protect it from light. The syringe must not be kept at room temperature (25°C) for longer than 48 hours before use.

• Do not use the syringe after the expiry date printed on the carton and syringe label. If expired, return the entire package to the pharmacy.

Injection site

The injection site is the part of the body where the syringe will be used.

• The recommended site is the front of the thighs. The lower abdomen may also be used, but not the area within 5 centimeters around the navel.
• If more than one injection is needed to administer the full dose, select a different injection site each time.
• Do not inject into areas where the skin is tender, damaged, red, or hard. Avoid areas with scars or stretch marks. If the injection is administered by a caregiver, the outer upper arms may also be used.

Preparation for use of Xolair injectable solution in prefilled syringe
Note: Depending on the dose prescribed by your doctor, you may need to prepare one or more
prefilled syringes and inject the contents of all these syringes. The following table provides examples of
how many injections of each dosage strength are required for a given dose:

1. Remove the carton containing the syringe from the refrigerator and leave it closed for about 30 minutes to allow it to reach room temperature (leave the syringe in the carton to protect it from light).
2. When it is time to use the syringe, wash your hands thoroughly with soap and water.
3. Clean the injection site with an alcohol swab.
4. Remove the paper tray from the carton and peel off the paper film. Lift the syringe from the tray, holding it at the center of the blue shield.
5. Examine the syringe. The liquid should be clear or slightly cloudy. Its color may range from colorless to pale yellow-brown. A small air bubble may be visible, which is normal. DO NOT USE the syringe if it is broken or if the liquid is distinctly cloudy, distinctly brown, or contains particles. In any of these cases, return the entire package to the pharmacy.
6. Holding the syringe horizontally, look through the observation window to check the expiry date printed on the label. Note: You may rotate the inner part of the syringe body to read the label through the observation window. DO NOT USE the medicine if it has expired. If expired, return the entire package to the pharmacy.

How to use Xolair injectable solution in prefilled syringe

Carefully remove the needle cap
from the syringe. Discard the needle cap.
A small drop of liquid at the tip of the needle may be visible. This is normal.

Gently pinch the skin at the injection site
and insert the needle as shown in the figure.
Push the needle fully in to ensure complete
delivery of the medicine.

Hold the syringe as shown in the figure.
Slowly push the plunger down completely
until the plunger head is fully within the
syringe’s safety wings.

Continue to keep the plunger
fully depressed while carefully
withdrawing the needle from the injection site.
Slowly release the plunger and allow

the syringe’s safety shield to
automatically cover the exposed needle.
There may be a small amount of blood at the
injection site. You may press a cotton ball or gauze
over the injection site and hold it in place for 30 seconds. Do not massage the injection site. If needed, the injection site may be covered with a small bandage.
Disposal instructions
Immediately dispose of the used syringe in a

sharps disposal container (puncture-resistant,
closable). For your safety and others’, used needles and syringes must never
be reused. Any unused medicine and waste material must be disposed of in accordance with local regulations. Do not dispose of any
medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Package leaflet: information for the user

Xolair 75 mg solution for injection in pre-filled syringe

(pre-filled syringe with 27-gauge attached needle, blue plunger)
omalizumab
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Xolair is and what it is used for
2. What you need to know before using Xolair
3. How to use Xolair
4. Possible side effects
5. How to store Xolair
6. Contents of the pack and other information

1. What is Xolair and what is it used for?

Xolair contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
natural proteins produced by the body. It belongs to a class of medicines called monoclonal
antibodies.
Xolair is used to treat:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of severe allergic
asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma
medicines, but whose asthma symptoms are not well controlled with medications such as high-dose
inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age)
who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but whose
symptoms are not well controlled with these medicines. Nasal polyps are small growths on the mucous
membrane of the nose. Xolair helps reduce the size of nasal polyps and improves symptoms, including
nasal congestion, loss of smell, mucus in the back of the throat, and runny nose.
Xolair works by blocking a substance known as immunoglobulin E (IgE), which is produced by the
body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and
chronic rhinosinusitis with nasal polyps.

2. What you need to know before using Xolair

Do not use Xolair

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of the ingredients, tell your doctor, as you must not use Xolair.

Warnings and precautions
Talk to your doctor before using Xolair:

• if you have kidney or liver problems;
• if you have a condition in which your immune system attacks part of your body (autoimmune disease);
• if you are planning to travel to areas where infections caused by parasites are common, because Xolair may reduce your resistance to these infections;
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, due to a medicine, an insect sting, or food.

Xolair does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Xolair
must not be used to treat these symptoms.
Do not use Xolair to prevent or treat other allergic conditions such as sudden allergic reactions,
hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease),
food allergy, eczema, or hay fever, because Xolair has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious side effects
Xolair may potentially cause serious side effects. You should be aware of the signs of these
conditions while using Xolair. Seek immediate medical help if you notice any sign of a severe
allergic reaction or other serious side effects. These signs are listed in section 4 under “Serious side effects”.
Before you self-inject Xolair or before someone who is not a healthcare professional administers the injection, it is important that your doctor provides you with instructions on how to recognize early symptoms of severe allergic reactions and how to manage these reactions if they occur (see section 3, “How to use Xolair”). Most severe allergic reactions occur within the first 3 doses of Xolair.
Children and adolescents
Allergic asthma
Xolair is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Xolair is not recommended for children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Other medicines and Xolair
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines to treat an infection caused by a parasite, as Xolair may reduce the effectiveness of these medicines;
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine. Your doctor will discuss with you the benefits and potential risks of using this medicine during pregnancy.
If you become pregnant while being treated with Xolair, inform your doctor immediately.
Xolair may pass into breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice before using this medicine.
Driving and using machines
It is unlikely that Xolair will affect your ability to drive vehicles or operate machinery.

3. How to use Xolair

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, nurse, or pharmacist.

How Xolair is used
Xolair is administered as an injection under the skin (known as a subcutaneous injection).

Xolair injection

• You and your doctor will decide whether you can self-inject Xolair. The first 3 doses must always be administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained in how to inject the medicine before giving yourself an injection.
• A person assisting you (e.g. a family member) may also administer the Xolair injection after receiving proper training.

For detailed instructions on how to inject Xolair, please read the “Instructions for the use of Xolair pre-filled syringe” at the end of this leaflet.

Instructions on recognizing severe allergic reactions
It is also important that you do not self-inject Xolair until your doctor or nurse has trained you on:

• how to recognize early signs and symptoms of severe allergic reactions;
• what to do if symptoms occur. For further information on early signs and symptoms of severe allergic reactions, see section 4.

Dosage
Your doctor will determine the dose of Xolair you need and how often you should use it. This depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE levels.

You will need between 1 and 4 injections at a time. You will require injections every two weeks or every four weeks.

Continue taking your current asthma and/or nasal polyps medication during treatment with Xolair. Do not stop taking your asthma and/or nasal polyps medications without first consulting your doctor.

You may not notice immediate improvement after starting treatment with Xolair. In patients with nasal polyps, effects are typically seen after 4 weeks of treatment. In patients with asthma, the full effect is usually achieved after 12–16 weeks.

Use in children and adolescents

Allergic asthma
Xolair can be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled by high-dose inhaled corticosteroids and inhaled beta-agonists. Your doctor will determine the appropriate dose of Xolair for the child and how often it should be administered. This will depend on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s IgE levels.

Self-administration of Xolair is not intended for children (aged 6 to 11 years). However, if considered appropriate by the doctor, the Xolair injection may be given by a caregiver after proper training.

Chronic rhinosinusitis with nasal polyps
Xolair must not be used in children and adolescents under 18 years of age.

If you miss a dose of Xolair
If you miss an appointment, contact your doctor or hospital as soon as possible to schedule a new one. If you forget to administer a dose of Xolair, inject the missed dose as soon as you remember. Then contact your doctor to determine when you should receive your next dose.

If you stop treatment with Xolair
Do not stop treatment with Xolair unless instructed by your doctor. Stopping or interrupting treatment with Xolair may cause your symptoms to return.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects caused by Xolair are usually mild or moderate in severity, but occasionally they can be serious.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical attention:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea, or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Xolair, you may have an increased risk of developing a severe allergic reaction following the use of Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood vessels or lymphatic vessels, elevated levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, or tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• Fever (in children)

Common (may affect up to 1 in 10 people)

• Reactions at the injection site such as pain, swelling, itching, and redness
• Pain in the upper abdomen
• Headache (very common in children)
• Dizziness
• Joint pain (arthralgia)

Uncommon (may affect up to 1 in 100 people)

• Feeling sleepy or tired
• Tingling or numbness in the hands or feet
• Fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• Sore throat, cough, acute breathing problems
• Feeling unwell (nausea), diarrhoea, indigestion
• Itching, hives, rash, increased sensitivity of the skin to sunlight
• Weight gain
• Flu-like symptoms
• Swollen arms

Rare (may affect up to 1 in 1,000 people)

• Parasitic infection

Not known (frequency cannot be estimated from the available data)

• Muscle pain and joint swelling
• Hair loss

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xolair

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled syringe may be stored for a total of up to 48 hours at room temperature (25°C). Keep in the original packaging to protect from light. Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use if the packaging is damaged or shows any signs of tampering.

6. Package contents and other information

What Xolair contains

• The active substance is omalizumab. One pre-filled syringe containing 0.5 mL of solution contains 75 mg of omalizumab.
• The other components are arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, and water for injections.

Description of the appearance of Xolair and contents of the pack
Xolair injectable solution is a clear or slightly opalescent, colourless to pale yellowish-brown solution contained in a pre-filled syringe.
Xolair 75 mg solution for injection in pre-filled syringe with a preservative-free needle, gauge 27, with blue plunger, is available in packs containing 1 pre-filled syringe and in multiple packs containing 3 (3 x 1) or 6 (6 x 1) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF XOLAIR PRE-FILLED SYRINGE

These “Instructions for Use” contain information on how to inject Xolair.
If your doctor decides that you or a caregiver may administer the Xolair injection at home, make sure your doctor or nurse shows you or the caregiver how to prepare and give the injection with the Xolair pre-filled syringe before using it for the first time.
Children under 12 years of age are not expected to self-inject Xolair. However, if the doctor considers it appropriate, a caregiver may administer the Xolair injection after receiving adequate training.
Make sure you have read and understood these “Instructions for Use” before administering the injection with the

Xolair pre-filled syringe. If you have any questions, consult your doctor.

Plunger
Plunger rod
Safety
wings
Expiry date
Safety
guard
Observation
window
Needle
Needle
cap
Important information you need to know before injecting Xolair

• Xolair is for subcutaneous injection only (injection directly into the fatty layer beneath the skin).
• Do not use the pre-filled syringe if the seal on the carton or the seal of the plastic tray is broken.
• Do not use if the pre-filled syringe has been dropped on a hard surface or if it has been dropped after removing the needle cap.
• Do not inject if the pre-filled syringe has been out of the refrigerator for a total period exceeding 48 hours. Dispose of the syringe (see Step 12) and use a new pre-filled syringe for injection.
• The pre-filled syringe has a safety guard that automatically activates to cover the needle after the injection. The safety guard helps prevent needlestick injuries to people handling the pre-filled syringe after injection.
• Do not attempt to reuse or disassemble the pre-filled syringe.
• Do not pull back the plunger.

How to store Xolair

• Store in the refrigerator (2°C to 8°C). Before use, the carton containing the pre-filled syringe may be stored at room temperature (25°C) for a total period of up to 48 hours.
• Do not freeze.
• Keep the pre-filled syringe in its original packaging until use to protect it from light.
• Keep the pre-filled syringe out of the sight and reach of children.

DOSING TABLE
Xolair pre-filled syringe is available in 3 dose strengths (one pre-filled syringe per carton).
These instructions apply to all 3 dose strengths.
Depending on the dose prescribed by your doctor, you will need to select one or more pre-filled syringes and inject the entire contents to administer the full dose. The Dosing Table below lists the combinations of pre-filled syringes required to deliver the full dose.

If you have any doubts about the Dosage Table, consult your doctor.

Xolair 75 mg pre-filled syringe with plunger Xolair 150 mg pre-filled syringe with plunger Xolair 300 mg pre-filled syringe with plunger
Blue plunger Violet plunger Grey plunger
Blue plunger Violet plunger Grey plunger
Pre-filled syringes Blue Violet Grey
DOSE
Required for the 75 mg 150 mg 300 mg
dose
75 mg 1 blue
150 mg 1 violet
225 mg 1 blue + 1 violet
300 mg (over 12 years of age) 1 grey
300 mg (children under
2 violet
12 years of age)
375 mg (over 12 years of age) 1 blue + 1 grey
375 mg (children under
1 blue + 2 violet
12 years of age)
450 mg (over 12 years of age) 1 violet + 1 grey
450 mg (children under
3 violet
12 years of age)
525 mg (over 12 years of age) 1 blue + 1 violet + 1 grey
525 mg (children under
12 years of age) 1 blue + 3 violet
600 mg (over 12 years of age) 2 grey
600 mg (children under
4 violet
12 years of age)

Preparing the Xolair Injection

Step 1. Bring to room temperature
Remove the carton containing the pre-filled syringe from the refrigerator, do not open it, and allow it to reach room temperature (at least 30 minutes).
Note: If more than one pre-filled syringe (each carton contains one pre-filled syringe) is required to administer the full dose (see Dosage Table), remove all cartons from the refrigerator at the same time.

Step 2. Prepare materials needed for injection
You will need the following items (not included in the carton):

• alcohol swab
• cotton ball or gauze pad
• sharps disposal container
• adhesive bandage

Step 3. Remove the syringe
Open the plastic tray by lifting the protective film. Remove the pre-filled syringe by holding it in the center, as shown.
Do not remove the needle cap until just before injection.

Step 4. Examine the pre-filled syringe

Look through the inspection window of the pre-filled syringe. The liquid inside should range from clear to slightly cloudy. The color may vary from colorless to pale yellow-brown. Air bubbles in the liquid may be visible, but this is normal. Do not attempt to remove the air bubbles. Inspection window

• Do not use the pre-filled syringe if the liquid contains particles, or if it is clearly cloudy or clearly brown.
• Do not use the pre-filled syringe if it appears damaged or has leaked.
• Do not use the pre-filled syringe after the expiration date printed on the pre-filled syringe label (EXP) and on the carton (Scad.).

In any of these cases, consult your doctor, nurse, or pharmacist.

Step 5. Choose the injection site

The injection should be administered in the front of the thighs or the lower abdomen, but not within a 5-centimeter radius around the navel.
Do not inject where the skin is tender, damaged, red, scaly, hard, or in areas with scars or stretch marks.
Note: If more than one pre-filled syringe is required to administer the full dose, administer injections at least 2 cm apart from each other.
If the injection is administered by a caregiver, doctor, or nurse, the outer upper arms may also be used.

Administering Xolair

Step 6. Clean the injection site
Wash your hands.
Clean the chosen injection site with an alcohol swab. Allow it to dry before injecting.
Do not touch or blow on the cleaned skin before injection.

Step 7. Remove the needle cap
Firmly pull off the needle cap from the pre-filled syringe. A small drop of liquid may be visible at the tip of the needle. This is normal.
Do not replace the needle cap. Discard the needle cap.

Step 8. Insert the needle
Gently pinch the skin at the injection site and maintain the pinch throughout the entire injection. With the other hand, insert the needle into the skin at an angle of approximately 45 degrees, as shown.
Do not press the plunger while inserting the needle.

Step 9. Begin the injection
Continue pinching the skin. Slowly push the plunger all the way down. This delivers the full dose.

Step 10. Complete the injection
Ensure the plunger head is between the safety shield wings, as shown. This allows the safety shield to activate and cover the needle after the injection.

Step 11. Release the plunger
While keeping the pre-filled syringe in place at the injection site, slowly release the plunger until the safety shield automatically covers the needle. Remove the syringe from the injection site and release the skin pinch.
There may be a small amount of blood at the injection site. You may press a cotton ball or gauze pad over the injection site until bleeding stops. Do not rub the injection site. If needed, cover the injection site with a small adhesive bandage.
Note: If more than one pre-filled syringe is required to administer the full dose, dispose of the used syringe as described in Step 12.
Repeat Steps 2 through 12 for each pre-filled syringe required to administer the full dose.
Administer injections immediately one after the other.
Ensure that injection sites are at least 2 cm apart.

After the injection

Step 12. Dispose of the pre-filled syringe
Immediately after use, place the pre-filled syringe into a sharps disposal container (i.e., a puncture-resistant, closable container).
Do not attempt to recap the needle.
Ask your doctor or pharmacist how to properly dispose of the sharps container. Local regulations may apply for disposal.

Package leaflet: information for the user

Xolair 75 mg solution for injection in a pre-filled pen

omalizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Xolair is and what it is used for
2. What you need to know before using Xolair
3. How to use Xolair
4. Possible side effects
5. How to store Xolair
6. Contents of the pack and other information

1. What Xolair is and what it is used for

Xolair contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
natural proteins produced by the body. It belongs to a class of medicines called monoclonal
antibodies.
Xolair is used for the treatment of:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal cavities) with nasal polyps

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of severe allergic
asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma
medicines, but in whom asthma symptoms are not well controlled by medications such as high-dose
inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age)
who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but in whom
symptoms are not well controlled by these medicines. Nasal polyps are small growths on the nasal
mucosa. Xolair helps reduce the size of nasal polyps and improves symptoms, including nasal
congestion, loss of smell, mucus in the back of the throat, and runny nose.
Xolair works by blocking a substance known as immunoglobulin E (IgE), which is produced by the
body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and
chronic rhinosinusitis with nasal polyps.

2. What you need to know before using Xolair

Do not use Xolair

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of the ingredients, tell your doctor, as you must not use Xolair.

Warnings and precautions
Talk to your doctor before using Xolair:

• if you have kidney or liver problems;
• if you have a condition in which your immune system attacks part of your body (autoimmune disease);
• if you plan to travel to areas where parasitic infections are common, because Xolair may reduce your resistance to these infections;
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, following a medicine, insect sting, or food.

Xolair does not treat acute asthma symptoms such as a sudden asthma attack. Therefore, Xolair must not be used to treat these symptoms.
Do not use Xolair to prevent or treat other allergic conditions such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease), food allergy, eczema, or hay fever, as Xolair has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious side effects
Xolair may potentially cause serious side effects. You should be aware of the signs of these conditions while using Xolair. Seek immediate medical help if you notice any sign of a severe allergic reaction or other serious side effects. These signs are listed in section 4, under "Serious side effects".
Before you self-inject Xolair or before someone who is not a healthcare professional administers the injection, it is important that your doctor provides you with instructions on how to recognize early symptoms of severe allergic reactions and how to manage these reactions if they occur (see section 3, "How to use Xolair"). Most severe allergic reactions occur within the first 3 doses of Xolair.
Children and adolescents
Allergic asthma
Xolair is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Xolair is not recommended for children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Other medicines and Xolair
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines for the treatment of a parasitic infection, as Xolair may reduce the effectiveness of these medicines;
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine. Your doctor will discuss with you the benefits and potential risks of using this medicine during pregnancy.
If you become pregnant while being treated with Xolair, inform your doctor immediately.
Xolair may pass into breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice before using this medicine.
Driving and using machines
It is unlikely that Xolair will affect your ability to drive or operate machinery.

3. How to use Xolair

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, nurse, or pharmacist.

How Xolair is used
Xolair is administered as an injection under the skin (known as a subcutaneous injection).

Xolair injection

• You and your doctor will decide whether you can inject Xolair yourself. The first 3 doses must always be administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained on how to inject the medicine before giving yourself an injection.
• A person assisting you (for example, a family member) may also administer the Xolair injection after having been adequately trained.

For detailed instructions on how to inject Xolair, please read the “Instructions for use of the Xolair pre-filled pen” at the end of this leaflet.

Instructions on how to recognize severe allergic reactions
It is also important that you do not self-inject Xolair until you have been trained by your doctor or nurse on:

• how to recognize early signs and symptoms of severe allergic reactions;
• what to do if symptoms occur. For further information on early signs and symptoms of severe allergic reactions, see section 4.

Dosage
Your doctor will determine the dose of Xolair you need and how often you should use it. This depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE level in the blood.
You will need between 1 and 4 injections at a time. You will require injections either every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Xolair. Do not stop taking your asthma and/or nasal polyps medication without first consulting your doctor.
You may not notice immediate improvement after starting treatment with Xolair. In patients with nasal polyps, effects are seen after 4 weeks of starting treatment. In patients with asthma, the full effect is usually achieved after 12–16 weeks.

Use in children and adolescents
Allergic asthma
Xolair can be used in children and adolescents aged 6 years and older who are already taking asthma medication but whose asthma symptoms are not well controlled by high-dose inhaled corticosteroids and inhaled beta agonists. Your doctor will determine the appropriate dose of Xolair needed and how often it should be administered. This will depend on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s IgE level in the blood.
Self-administration of Xolair is not intended for children (aged 6 to 11 years). However, if your doctor considers it appropriate, a caregiver may administer the Xolair injection after receiving proper training.
Xolair pre-filled pens must not be used in children under 12 years of age. In children aged 6 to 11 years with allergic asthma, Xolair 75 mg pre-filled syringe, Xolair 150 mg pre-filled syringe, or Xolair powder and solvent for injectable solution may be used.

Chronic rhinosinusitis with nasal polyps
Xolair must not be used in children and adolescents under 18 years of age.

If you miss a dose of Xolair
If you miss an appointment, contact your doctor or hospital as soon as possible to reschedule.
If you forget to administer a dose of Xolair, inject the missed dose as soon as you remember. Then contact your doctor to find out when you should administer the next dose.

If you stop treatment with Xolair
Do not stop treatment with Xolair unless your doctor tells you to. Stopping or interrupting treatment with Xolair may cause your symptoms to return.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects caused by Xolair are usually mild or moderate in severity but can occasionally be serious.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical attention:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Xolair, you may have an increased risk of developing a severe allergic reaction following the use of Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood or lymph vessels, elevated levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, tingling in arms, legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• reactions at the injection site such as pain, swelling, itching and redness
• pain in the upper abdomen
• headache (very common in children)
• feeling dizzy
• joint pain (arthralgia)

Uncommon (may affect up to 1 in 100 people)

• feeling sleepy or tired
• tingling or numbness in the hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute breathing problems
• feeling unwell (nausea), diarrhoea, indigestion
• itching, hives, rash, increased sensitivity of the skin to sunlight
• weight gain
• influenza-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known (frequency cannot be estimated from the available data)

• muscle pain and joint swelling
• hair loss

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xolair

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled pen can be stored for a total period of up to 48 hours at room temperature (25°C). Store in the original packaging to protect the medicine from light. Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use if the packaging is damaged or shows any signs of tampering.

6. Package contents and other information

What Xolair contains

• The active substance is omalizumab. One 0.5 mL pen contains 75 mg of omalizumab.
• The other ingredients are arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, and water for injections.

Description of the appearance of Xolair and package contents
Xolair injectable solution is a clear or slightly opalescent, colourless to pale yellowish-brown solution contained in a pre-filled pen.
Xolair 75 mg solution for injection in pre-filled pen is available in packs containing 1 pre-filled pen and in multiple packs containing 3 (3 x 1) or 6 (6 x 1) pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF XOLAIR PREFILLED PEN

These “Instructions for use” contain information on how to inject XOLAIR.
If your doctor decides that you or a caregiver may administer the Xolair injection at home, make sure your doctor or nurse shows you or the caregiver how to prepare and give the injection with the Xolair prefilled pen before using it for the first time.
The Xolair prefilled pen is intended for patients over 12 years of age.
Make sure you have read and understood these “Instructions for use” before administering the injection with the

Xolair pre-filled pen. If you have any doubts, consult your doctor.

Before use After use
xx mg xx mg
Device label with
Xolair
Xolair
brand name,
dosage, and expiry date
Observation window
Green indicator
Cap Needle shield
Protected needle inside
Important information you should know before injecting Xolair

• Xolair is for subcutaneous injection only (injection directly into the fatty layer under the skin).
• Do not use the pen if the seal on the carton is broken.
• Do not use the pen if it has been dropped after removing the cap.
• Do not use the pen if it has been kept outside the refrigerator for a total period exceeding 48 hours. Dispose of it (see Step 13) and use a new pen for the injection.
• Do not touch or press the needle shield, as you may injure yourself. Touching or pressing the needle shield could result in a needle-stick injury.
• Do not attempt to reuse or disassemble the pen.
• Do not try to re-cap the pen after removing the cap.

How to store Xolair

• Store in the refrigerator (2°C to 8°C). Before use, the carton containing the pen may be stored at room temperature (up to 25°C) for a total of 48 hours.
• Do not freeze.
• Keep the pen in its original packaging until ready to use, to protect it from light.
• Keep the pen out of the sight and reach of children.

DOSING TABLE
Xolair pens are available in 3 dosage strengths (one pen per carton). These instructions apply to all 3 strengths.
Depending on the dose prescribed by your doctor, you will need to select one or more pens and inject the full contents of each to administer the complete dose. The dosing table below shows the pen combinations required to deliver the full dose.
If you have any questions about the Dosing Table, consult your doctor.

Xolair 75 mg
Xolair 150 mg Xolair 300 mg
pen with blue needle shield pen with purple needle shield pen with grey needle shield
Blue needle shield Purple needle shield Grey needle shield
Dose Number of pens required Blue Purple Grey
for dose 75 mg 150 mg 300 mg
75 mg 1 blue
150 mg 1 purple
225 mg 1 blue + 1 purple
300 mg 1 grey
375 mg 1 blue + 1 grey
450 mg 1 purple + 1 grey
525 mg 1 blue + 1 purple + 1 grey
600 mg 1 grey + 1 grey

Preparing to inject Xolair
Step 1. Bring to room temperature
Remove the carton containing the pen from the refrigerator, do not open it, and allow it to reach room temperature (at least 30 minutes).
Note: If more than one pen (each carton contains one pen) is needed to administer the full dose (see Dosing Table), remove all cartons from the refrigerator at the same time.

Step 2. Prepare injection supplies
You will need the following items (not included in the carton):

• alcohol swab
• cotton ball or gauze pad
• sharps disposal container
• adhesive bandage

Step 3. Remove the pen

Take the pen out of the carton.
Do not remove the cap until just before injection.

Step 4. Examine the pen

Look through the observation window of the pen. The liquid inside should be clear to slightly cloudy. The color may range from colorless to pale yellow-brown. Air bubbles in the liquid are normal.

• Do not use the pen if the liquid contains particles or is clearly cloudy or clearly brown.
• Do not use the pen if it appears damaged.
• Do not use the pen after the expiry date printed on the label (EXP) and on the carton (Scad.).

If any of these conditions apply, consult your doctor, nurse, or pharmacist.
Expiry date

Step 5. Choose the injection site

The injection should be given in the front of the thighs or the lower abdomen, but not within 5 cm of the navel.
Do not inject where the skin is tender, damaged, red, scaly, or hard, or in areas with scars or stretch marks.
Note: If more than one pre-filled pen is needed to achieve the full dose, administer injections at least 2 cm apart from each other.
If the injection is administered by a caregiver, doctor, or nurse, the outer upper arm may also be used.

Injecting Xolair
Step 6. Clean the injection site
Wash your hands.
Clean the chosen injection site with an alcohol swab. Allow it to dry before injecting.
Do not touch or blow on the cleaned skin before injection.

Step 7. Remove the cap

Firmly pull the cap off in the direction of the arrow.
Do not re-cap the pen. Discard the cap.

Step 8. Position the pen

Hold the pen comfortably with the needle shield
pressed directly against the skin.
The pen must be held at a 90° angle to the skin, as shown.

Step 9. Start the injection

Press and hold the pen firmly against the skin.
You will hear the 1st click, indicating that the injection has started.
1st CLICK

Step 10. Monitor the injection

Continue to hold the pen firmly pressed against the skin. The green indicator shows the progress of the injection.

Step 11. Complete the injection

You will hear the 2nd click, indicating that the injection is almost complete.
2nd CLICK
Continue to hold the pen in place until the green indicator has stopped moving, to ensure the injection is fully completed. Remove the pen from the skin. The needle will be automatically covered by the needle shield. The injection is now complete.

After the injection
Step 12. Check the green indicator

If the green indicator has not completely filled the observation window, consult your doctor or nurse.
There may be a small amount of bleeding at the injection site.
You may press a cotton ball or gauze pad over the injection site until bleeding stops.
Do not rub the injection site. If needed, cover the injection site with a small adhesive bandage.
Note: If more than one pen is required to administer the full dose, dispose of the used pen as described in Step 13.
Repeat Steps 2 to 13 for each pen needed to deliver the full dose.
Perform injections immediately one after the other.
Ensure that injections are administered at least 2 cm apart from each other.

Step 13. Dispose of the pen
Immediately after use, place the used pen in a sharps disposal container (i.e., a closable, puncture-resistant container).
Ask your doctor or pharmacist how to properly dispose of the sharps container. Local regulations for disposal may apply.

Patient Information Leaflet: Information for the User

Xolair 150 mg solution for injection in pre-filled syringe

(pre-filled syringe with 26-gauge pre-attached needle, purple cap)
omalizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Xolair is and what it is used for
2. What you need to know before using Xolair
3. How to use Xolair
4. Possible side effects
5. How to store Xolair
6. Contents of the pack and other information

1. What Xolair is and what it is used for

Xolair contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
proteins naturally produced by the body. It belongs to a class of medicines called monoclonal
antibodies.
Xolair is used to treat:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal cavities) with nasal polyps
• chronic spontaneous urticaria (CSU)

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of severe allergic
asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma
medicines, but in whom asthma symptoms are not well controlled by medicines such as high-dose
inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age)
who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but in
whom symptoms are not well controlled by these medicines. Nasal polyps are small growths on the
nasal mucosa. Xolair helps reduce the size of the polyps and improves symptoms, including nasal
congestion, loss of sense of smell, mucus in the back of the throat, and runny nose.
Chronic spontaneous urticaria (CSU)
This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (from 12 years
of age) who are already taking antihistamines, but whose CSU symptoms are not well controlled by
these medicines.
Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body.
IgE contributes to a type of inflammation that plays a key role in causing allergic asthma, chronic
rhinosinusitis with nasal polyps, and CSU.

2. What you need to know before using Xolair

Do not use Xolair

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic to any of the ingredients, inform your doctor as you must not use Xolair.

Warnings and precautions
Talk to your doctor before using Xolair:

• if you have kidney or liver problems
• if you have a disorder in which your immune system attacks part of your body (autoimmune disease)
• if you plan to travel to areas where infections caused by parasites are common, because Xolair may reduce your resistance to these infections.
• if you have previously had a severe allergic reaction (anaphylaxis), for example, due to a medicine, an insect sting, or food.
• if you have ever had an allergic reaction to latex. The needle cap of the syringe may contain rubber (latex).

Xolair does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Xolair must not be used to treat these symptoms.
Do not use Xolair to prevent or treat other allergic conditions such as sudden allergic reactions, hyperimmunoglobulinemia E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease), food allergy, eczema, or hay fever, as Xolair has not been studied in these conditions.
Be alert to signs of allergic reactions and other serious side effects
Xolair may potentially cause serious side effects. You must be alert to the signs of these conditions while using Xolair. Seek immediate medical help if you notice any signs of a serious allergic reaction or other serious side effects. These signs are listed in section 4, under "Serious side effects".
Before you self-inject Xolair or before the injection is administered by someone who is not a healthcare professional, it is important that you receive instructions from your doctor on how to recognize early symptoms of severe allergic reactions and how to manage these reactions if they occur (see section 3, "How to use Xolair"). Most severe allergic reactions occur within the first 3 doses of Xolair.
Children and adolescents
Allergic asthma
Xolair is not recommended in children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Xolair is not recommended in children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Chronic spontaneous urticaria (CSU)
Xolair is not recommended in children under 12 years of age. Use in children under 12 years has not been studied.
Other medicines and Xolair
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines for the treatment of a parasitic infection, as Xolair may reduce the effectiveness of these medicines,
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will discuss with you the benefits and potential risks of using this medicine during pregnancy.
If you become pregnant while being treated with Xolair, inform your doctor immediately.
Xolair may pass into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.
Driving and using machines
It is unlikely that Xolair will affect your ability to drive or operate machinery.

3. How to use Xolair

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor, nurse, or pharmacist.

How to use Xolair
Xolair is administered as an injection under the skin (known as a subcutaneous injection).

Xolair injection

• Your doctor will decide whether you can inject Xolair yourself. The first 3 doses must always be administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained on how to inject the medicine before administering the injection yourself.
• A person assisting you (e.g. a family member) may also give you the Xolair injection after having been adequately trained.

For detailed instructions on how to inject Xolair, see “Instructions for using the Xolair pre-filled syringe” at the end of this leaflet.

Instructions on recognizing severe allergic reactions
It is also important that you do not self-inject Xolair until you have been instructed by your doctor or nurse on:

• how to recognize early signs and symptoms of a severe allergic reaction;
• what to do if symptoms occur. For further information on early signs and symptoms of severe allergic reactions, see section 4.

Dosage
Allergic asthma and chronic rhinosinusitis with nasal polyps
Your doctor will determine the dose of Xolair you need and how often you should use it. This depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE level in the blood.
You will need between 1 and 4 injections at a time. You will require injections every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Xolair. Do not stop taking your asthma and/or nasal polyps medications without first consulting your doctor.
You may not notice immediate improvement after starting Xolair treatment. In patients with nasal polyps, effects become apparent after 4 weeks of treatment. In patients with asthma, the full effect is usually achieved after 12–16 weeks.

Chronic spontaneous urticaria (CSU)
Two injections of 150 mg each will be required every four weeks.
Continue taking your current CSU medication during treatment with Xolair. Do not stop taking any medications without consulting your doctor.

Use in children and adolescents
Allergic asthma
Xolair can be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled by high-dose inhaled steroids and inhaled beta agonists. Your doctor will determine the amount of Xolair the child needs and how often it should be administered. This will depend on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s IgE level in the blood.
Self-administration of Xolair is not recommended for children (aged 6 to 11 years).
However, if your doctor considers it appropriate, the Xolair injection may be given by a caregiver after proper training.

Chronic rhinosinusitis with nasal polyps
Xolair must not be used in children and adolescents under 18 years of age.

Chronic spontaneous urticaria (CSU)
Xolair can be used in adolescents aged 12 years and older who are already taking antihistamines but whose CSU symptoms are not well controlled by these medications. The dose for adolescents aged 12 years and older is the same as for adults.

If you miss a dose of Xolair
If you miss an appointment, contact your doctor or hospital as soon as possible to schedule a new one.
If you forget to administer a dose of Xolair, inject the missed dose as soon as you remember. Then contact your doctor to determine when you should administer the next dose.

If you stop treatment with Xolair
Do not stop treatment with Xolair unless instructed by your doctor. Stopping or interrupting treatment with Xolair may cause symptoms to return.
However, if you are being treated for CSU, your doctor may temporarily discontinue Xolair treatment from time to time to assess your symptoms. Follow your doctor’s instructions.

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects caused by Xolair are usually mild or moderate in severity, but occasionally they can be serious.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical attention:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) unrelated to Xolair, you may have an increased risk of developing a severe allergic reaction following the use of Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood vessels or lymphatic vessels, elevated levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, or tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• Fever (in children)

Common (may affect up to 1 in 10 people)

• Injection site reactions such as pain, swelling, itching, and redness
• Pain in the upper abdomen
• Headache (very common in children)
• Upper respiratory tract infections such as pharyngitis and common cold
• Feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache)
• Joint pain (arthralgia)
• Dizziness

Uncommon (may affect up to 1 in 100 people)

• Feeling sleepy or tired
• Tingling or numbness in hands or feet
• Fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• Sore throat, cough, acute breathing problems
• Feeling unwell (nausea), diarrhoea, indigestion
• Itching, hives, rash, increased sensitivity of the skin to sunlight
• Weight gain
• Influenza-like symptoms
• Swollen arms

Rare (may affect up to 1 in 1,000 people)

• Parasitic infection

Not known (frequency cannot be estimated from the available data)

• Muscle pain and joint swelling
• Hair loss

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xolair

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled syringe can be stored for a total period of up to 48 hours at room temperature (25°C).
• Store in the original packaging to protect the medicine from light.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Do not use if the packaging is damaged or shows any signs of tampering.

6. Package contents and other information

What Xolair contains

• The active substance is omalizumab. One 1 mL syringe of solution contains 150 mg of omalizumab.
• The other components are arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, and water for injections.
• The needle cap of the syringe may contain dry rubber (latex).

Description of the appearance of Xolair and contents of the pack
Xolair solution for injection is a clear or slightly opalescent, colourless to pale yellowish-brown solution contained in a pre-filled syringe.
Xolair 150 mg solution for injection in pre-filled syringe with a presoldered 26-gauge needle and purple protective cap is available in packs containing 1 pre-filled syringe and in multiple packs containing 4 (4 x 1), 6 (6 x 1) or 10 (10 x 1) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF XOLAIR PREFILLED SYRINGE

Before the injection, read ALL of these instructions completely. If your doctor decides that you or a caregiver may administer the Xolair injection at home, you must be trained by a doctor, nurse, or pharmacist before self-injecting or injecting someone else.
Children (aged 6 to less than 12 years) are not expected to self-inject Xolair; however, if the doctor considers it appropriate, a caregiver may administer the injection after receiving proper training. The carton contains a plastic tray with individually sealed prefilled syringe(s) of Xolair.
Xolair 150 mg injectable solution in prefilled syringe
Plunger
Flange
Stopper

Syringe
Observation
Needle
Syringe
Syringe
Label and
Window
Cover
Guard
Cap
Expiration Date
After injecting the medicine, the syringe guard is automatically activated, covering the needle. This is to protect against accidental needle-stick injuries.

What else is needed for the injection:

• Alcohol swab
• Gauze or cotton ball
• Sharps disposal container

Important safety information
Warning: Keep the syringe out of the sight and reach of children.

• The needle cap may contain rubber (latex) and must not come into contact with individuals allergic to this substance.
• Do not open the sealed outer carton until the time of medicine use.
• Do not use this medicine if the carton seal or the plastic tray seal is broken, as use may not be safe.
• Do not use the syringe if it has fallen onto a hard surface or if it has been dropped after removing the needle cap.
• Do not leave the syringe where others could tamper with it.
• Do not shake the syringe.
• Be careful not to touch the syringe guard wings before use. Touching them may cause premature activation of the syringe guard.
• Do not remove the needle cap until the time of injection.
• The syringe is not reusable. Immediately dispose of the used syringe in a sharps disposal container after use.

Storage of Xolair injectable solution in prefilled syringe

• Store the sealed medicine in the carton to protect it from light. Store in a refrigerator at 2°C to 8°C. DO NOT FREEZE.
• Remember to remove the syringe from the refrigerator so it can reach room temperature (25°C) before preparing for injection (this takes approximately 30 minutes). Leave the syringe in the carton to protect it from light. The syringe must not remain at room temperature (25°C) for longer than 48 hours before use.
• Do not use the syringe after the expiration date printed on the carton and syringe label. If expired, return the entire package to the pharmacy.

Injection site

The injection site is the part of the body where the syringe will be used.

• The recommended site is the front of the thighs. The lower abdomen may also be used, but not the area within 5 centimeters around the navel.
• If more than one injection is required for the full dose, select a different injection site each time.
• Do not inject into areas where the skin is tender, damaged, red, or hard. Avoid areas with scars or stretch marks. If the injection is administered by a caregiver, the outer upper arms may also be used.

Preparation for use of Xolair injectable solution in prefilled syringe
Note: Depending on the dose prescribed by your doctor, you may need to prepare one or more prefilled syringes and inject the contents of all syringes. The following table provides examples of how many injections of each dosage strength are needed for a given dose:

1. Remove the carton containing the syringe from the refrigerator and leave it closed for about 30 minutes to allow the syringe to reach room temperature (leave the syringe in the carton to protect it from light).
2. When ready to use the syringe, wash your hands thoroughly with soap and water.
3. Clean the injection site with an alcohol swab.
4. Remove the paper tray from the carton and peel off the paper film. Lift the syringe from the tray by holding the center of the blue guard.
5. Examine the syringe. The liquid should be clear or slightly cloudy. Its color may range from colorless to pale yellow-brown. A small air bubble may be visible, which is normal. DO NOT USE the syringe if it is broken or if the liquid is distinctly cloudy, distinctly brown, or contains particles. In these cases, return the entire package to the pharmacy.
6. Holding the syringe horizontally, look through the observation window to check the expiration date printed on the label. Note: The inner part of the syringe barrel can be rotated to allow reading of the label through the observation window. DO NOT USE the medicine if it is expired. If expired, return the entire package to the pharmacy.

How to use Xolair injectable solution in prefilled syringe

Carefully remove the needle cap from the syringe. Discard the needle cap. A small drop of liquid at the tip of the needle may be visible. This is normal.

Gently pinch the skin at the injection site and insert the needle as shown in the figure. Push the needle fully in to ensure complete delivery of the medicine.

Hold the syringe as shown in the figure. Slowly push the plunger down completely until the plunger stopper is fully within the syringe guard wings.

Continue to hold the plunger fully depressed while carefully withdrawing the needle from the injection site.
Slowly release the plunger and allow

the syringe guard to automatically cover the exposed needle.
There may be a small amount of blood at the injection site. Press a cotton ball or gauze pad against the site and hold for 30 seconds. Do not rub the injection site. If needed, the injection site may be covered with a small adhesive bandage.

Disposal instructions

Immediately dispose of the used syringe in a sharps disposal container (puncture-resistant, leak-proof, and with a lid). For your safety and the safety of others, used needles and syringes must never be reused. Any unused medicine and waste materials from this medicine must be disposed of in accordance with local regulations. Do not flush medicines down the toilet or into household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

Patient Information Leaflet: Information for the User

Xolair 150 mg solution for injection in pre-filled syringe

(pre-filled syringe with 27-gauge pre-attached needle, purple plunger)
Xolair 300 mg solution for injection in pre-filled syringe
omalizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Xolair is and what it is used for
2. What you need to know before using Xolair
3. How to use Xolair
4. Possible side effects
5. How to store Xolair
6. Contents of the pack and other information

1. What is Xolair and what is it used for?

Xolair contains the active substance omalizumab. Omalizumab is a synthetic protein similar to the
natural proteins produced by the body. It belongs to a class of medicines called monoclonal antibodies.
Xolair is used to treat:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps
• chronic spontaneous urticaria (CSU)

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of moderate-to-severe
allergic asthma in adults, adolescents, and children (from 6 years of age) who are already receiving
asthma medications, but whose asthma symptoms are not well controlled with medications such as
high-dose inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age)
who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but whose
symptoms are not well controlled with these medicines. Nasal polyps are small growths on the nasal
mucosa. Xolair helps reduce the size of nasal polyps and improves symptoms, including nasal
congestion, loss of smell, mucus in the back of the throat, and runny nose.
Chronic spontaneous urticaria (CSU)
This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (from 12 years of
age) who are already taking antihistamines, but whose CSU symptoms are not well controlled with
these medicines.
Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body.
IgE contributes to a type of inflammation that plays a key role in causing allergic asthma, chronic
rhinosinusitis with nasal polyps, and CSU.

2. What you need to know before using Xolair

Do not use Xolair

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of the ingredients, inform your doctor, as you must not use Xolair.

Warnings and precautions
Talk to your doctor before using Xolair:

• if you have kidney or liver problems
• if you have a condition in which your immune system attacks part of your body (autoimmune disease)
• if you plan to travel to areas where parasitic infections are common, because Xolair may reduce your resistance to these infections
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, to a medicine, insect sting, or food.

Xolair does not treat acute asthma symptoms, such as sudden asthma attacks. Therefore, Xolair must not be used to treat these symptoms.
Do not use Xolair to prevent or treat other allergic conditions such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease), food allergy, eczema, or hay fever, as Xolair has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious adverse effects
Xolair may potentially cause serious adverse effects. You should be alert for signs of these conditions while using Xolair. Seek immediate medical help if you notice any sign of a severe allergic reaction or other serious adverse effects. These signs are listed in section 4 under “Serious adverse effects”.
Before you self-inject Xolair or before someone who is not a healthcare professional administers the injection, it is important that your doctor provides instructions on how to recognize early symptoms of severe allergic reactions and how to manage these reactions if they occur (see section 3, “How to use Xolair”). Most severe allergic reactions occur within the first 3 doses of Xolair.

Children and adolescents
Allergic asthma
Xolair is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Xolair is not recommended for children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Chronic spontaneous urticaria (CSU)
Xolair is not recommended for children under 12 years of age. Use in children under 12 years has not been studied.

Other medicines and Xolair
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines used to treat a parasitic infection, as Xolair may reduce the effectiveness of these medicines
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will discuss with you the benefits and potential risks of using this medicine during pregnancy.
If you become pregnant while being treated with Xolair, inform your doctor immediately.
Xolair may pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine.

Driving and using machines
It is unlikely that Xolair will affect your ability to drive or operate machinery.

3. How to use Xolair

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.
How to use Xolair
Xolair is administered as an injection under the skin (known as a subcutaneous injection).
Xolair injection

• You and your doctor will decide whether you can self-inject Xolair. The first 3 doses are always administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained in how to inject the medicine before giving yourself an injection.
• A person assisting you (e.g. a relative) may also administer Xolair after being adequately trained.

For detailed instructions on how to inject Xolair, see “Instructions for use of Xolair pre-filled syringe” at the end of this leaflet.
Instructions on how to recognize severe allergic reactions
It is also important that you do not self-inject Xolair until you have been trained by your doctor or nurse on:

• how to recognize early signs and symptoms of a severe allergic reaction;
• what to do if symptoms occur. For further information on early signs and symptoms of severe allergic reactions, see section 4.

Dosage
Allergic asthma and chronic rhinosinusitis with nasal polyps
Your doctor will determine the dose of Xolair you need and how often you should use it. This depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE levels in the blood.
You will need between 1 and 4 injections at a time. You will require injections every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Xolair. Do not stop taking your asthma and/or nasal polyps medication without first consulting your doctor.
You may not notice immediate improvement after starting Xolair treatment. In patients with nasal polyps, effects are seen after 4 weeks of starting treatment. In asthmatic patients, full effect is usually achieved after 12–16 weeks.
Chronic spontaneous urticaria (CSU)
Two injections of 150 mg each at a time or one injection of 300 mg every four weeks will be required.
Continue taking your current CSU medication during treatment with Xolair. Do not stop taking your medication without consulting your doctor.
Use in children and adolescents
Allergic asthma
Xolair can be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled with high-dose inhaled corticosteroids and inhaled beta agonists. Your doctor will determine the amount of Xolair needed and how often it should be administered. This will depend on the child's body weight and the results of a blood test performed before starting treatment to measure the child's IgE levels in the blood.
Self-administration of Xolair is not recommended for children (aged 6 to 11 years).
However, if your doctor considers it appropriate, Xolair injections may be given by a caregiver after proper training.
Xolair 300 mg pre-filled syringe must not be used in children under 12 years of age. In children aged 6 to 11 years with allergic asthma, Xolair 75 mg pre-filled syringe, Xolair 150 mg pre-filled syringe, or Xolair powder and solvent for injectable solution may be used.
Chronic rhinosinusitis with nasal polyps
Xolair must not be used in children and adolescents under 18 years of age.
Chronic spontaneous urticaria (CSU)
Xolair can be used in adolescents aged 12 years and older who are already taking antihistamines but whose CSU symptoms are not well controlled with these medications. The dose for adolescents aged 12 years and older is the same as for adults.
If you miss a dose of Xolair
If you miss an appointment, contact your doctor or hospital as soon as possible to schedule a new one.
If you forget to administer a dose of Xolair, inject the missed dose as soon as you remember. Then contact your doctor to determine when you should administer the next dose.
If you stop treatment with Xolair
Do not stop treatment with Xolair unless instructed by your doctor. Stopping or interrupting treatment with Xolair may cause symptoms to return.
However, if you are being treated for CSU, your doctor may temporarily discontinue Xolair treatment from time to time to assess your symptoms. Follow your doctor's instructions.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects caused by Xolair are usually mild or moderate in severity, but occasionally they can be severe.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical help:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: skin rash, itching or hives, swelling of the face, lips, tongue, larynx (vocal cords), trachea, or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) unrelated to Xolair, you may have an increased risk of developing a severe allergic reaction following the use of Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, skin rash, fever, weight loss, and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain, or rash around blood or lymph vessels, high levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, or tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as unusual bleeding or bruising.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• Fever (in children)

Common (may affect up to 1 in 10 people)

• Injection site reactions such as pain, swelling, itching, and redness
• Pain in the upper part of the stomach
• Headache (very common in children)
• Upper respiratory tract infections such as pharyngitis and common cold
• Feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache)
• Joint pain (arthralgia)
• Dizziness

Uncommon (may affect up to 1 in 100 people)

• Feeling drowsy or tired
• Tingling or numbness in hands or feet
• Fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• Sore throat, cough, acute breathing problems
• Feeling unwell (nausea), diarrhea, indigestion
• Itching, hives, rash, increased sensitivity of the skin to sunlight
• Weight gain
• Flu-like symptoms
• Swollen arms

Rare (may affect up to 1 in 1,000 people)

• Parasitic infection

Not known (frequency cannot be estimated from the available data)

• Muscle pain and joint swelling
• Hair loss

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xolair

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled syringe may be stored for a total period of 48 hours at room temperature (25°C).
• Store in the original packaging to protect the medicine from light.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Do not use if the packaging is damaged or shows signs of tampering.

6. Package contents and other information

What Xolair contains

• The active substance is omalizumab.
• A 1 mL syringe of solution contains 150 mg of omalizumab.
• A 2 mL syringe of solution contains 300 mg of omalizumab.
• The other components are arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, and water for injections.

Description of the appearance of Xolair and contents of the pack
Xolair injectable solution is a clear or slightly opalescent, colourless to pale yellowish-brown solution contained in a pre-filled syringe.
Xolair 150 mg solution for injection in pre-filled syringe with a 27-gauge pre-attached needle and a purple plunger is available in packs containing 1 pre-filled syringe and in multiple packs containing 3 (3 x 1) or 6 (6 x 1) pre-filled syringes.
Xolair 300 mg solution for injection in pre-filled syringe is supplied in packs containing 1 pre-filled syringe and in multiple packs containing 3 (3 x 1) or 6 (6 x 1) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF XOLAIR PREFILLED SYRINGE

These “Instructions for Use” contain information on how to inject Xolair.
If your doctor decides that you or a caregiver may administer Xolair injections at home, make sure your doctor or nurse shows you or the caregiver how to prepare and administer the injection using the Xolair prefilled syringe before using it for the first time.
Children under 12 years of age are not expected to self-inject Xolair. However, if the doctor considers it appropriate, a caregiver may administer the Xolair injection after receiving proper training.
Make sure you have read and understood these “Instructions for Use” before administering the injection with the

Xolair pre-filled syringe. If you have any doubts, please consult your doctor.

Plunger head
Plunger
Safety shield wings
Expiry date
Safety shield
Observation window
Needle
Needle cap
Important information you must know before injecting Xolair

• Xolair is for subcutaneous injection only (injection directly into the fatty layer beneath the skin).
• Do not use the pre-filled syringe if the seal on the carton or the seal of the plastic tray is broken.
• Do not use if the pre-filled syringe has been dropped onto a hard surface or if it has been dropped after removing the needle cap.
• Do not inject if the pre-filled syringe has been out of the refrigerator for a total period exceeding 48 hours. Dispose of the syringe (see Step 12) and use a new pre-filled syringe for injection.
• The pre-filled syringe has a safety shield that automatically activates to cover the needle after injection. The safety shield helps prevent needlestick injuries to anyone handling the pre-filled syringe after injection.
• Do not attempt to reuse or disassemble the pre-filled syringe.
• Do not pull back the plunger.

How to store Xolair

• Store in a refrigerator (from 2°C to 8°C). Before use, the carton containing the pre-filled syringe may be stored at room temperature (25°C) for a total period of up to 48 hours.

• Do not freeze.

• Keep the pre-filled syringe in its original packaging until use to protect it from light.

• Keep the pre-filled syringe out of the sight and reach of children.

• DOSING TABLE

Xolair pre-filled syringe is available in 3 dose strengths (one pre-filled syringe per carton).
These instructions apply to all 3 dose strengths.
Depending on the dose prescribed by your doctor, you will need to select one or more pre-filled syringes and inject all of their contents to administer the full dose. The Dosing Table below indicates the combinations of pre-filled syringes required to deliver the full dose.

If you have any doubts about the Dosing Table, consult your doctor.

Xolair 75 mg pre-filled syringe Xolair 150 mg pre-filled syringe Xolair 300 mg pre-filled syringe
with blue plunger with purple plunger with grey plunger
blue purple grey
Blue plunger Purple plunger Grey plunger
DOSE Blue Purple Grey
75 mg 150 mg 300 mg
75 mg 1 blue
150 mg 1 purple
225 mg 1 blue + 1 purple
300 mg (over 12 years of age) 1 grey
300 mg (children under
2 purple
12 years of age)
375 mg (over 12 years of age) 1 blue + 1 grey
375 mg (children under
1 blue + 2 purple
12 years of age)
450 mg (over 12 years of age) 1 purple + 1 grey
450 mg (children under
3 purple
12 years of age)
525 mg (over 12 years of age) 1 blue + 1 purple + 1 grey
525 mg (children under
1 blue + 3 purple
12 years of age)
600 mg (over 12 years of age) 2 grey
600 mg (children under
4 purple
12 years of age)

Preparing the Xolair injection
Step 1. Bring to room temperature
Remove the carton containing the pre-filled syringe from the refrigerator, do not open it, and allow it to reach room temperature (at least 30 minutes).
Note: If more than one pre-filled syringe (each carton contains one pre-filled syringe) is needed to administer the full dose (see Dosing Table), remove all cartons from the refrigerator at the same time.

Step 2. Prepare what is needed for the injection
You will need the following items (not included in the carton):

• alcohol swab
• cotton ball or gauze pad
• sharps disposal container
• adhesive bandage

Step 3. Remove the syringe

Open the plastic tray by lifting the protective film. Remove the pre-filled syringe by holding it in the center, as shown.
Do not remove the needle cap until just before injection.

Step 4. Examine the pre-filled syringe

Look through the inspection window of the pre-filled syringe. The liquid inside should be from clear to slightly cloudy. The color may vary from colorless to pale yellow-brown. Air bubbles may be visible in the liquid, but this is normal. Do not attempt to remove the air bubbles. Inspection window

• Do not use the pre-filled syringe if the liquid contains particles, or if it is clearly cloudy or clearly brown.
• Do not use the pre-filled syringe if it appears damaged or has leaked.
• Do not use the pre-filled syringe after the expiry date printed on the label of the pre-filled syringe (EXP) and on the carton (Scad.).

In any of these cases, consult your doctor, nurse, or pharmacist.

Step 5. Choose the injection site

The injection should be given in the front of the thighs or the lower abdomen, but not within a 5 cm area around the navel.
Do not inject where the skin is tender, damaged, red, scaly, hard, or in areas with scars or stretch marks.
Note: If more than one pre-filled syringe is needed to administer the full dose, administer the injections at least 2 cm apart from each other.
If the injection is administered by a caregiver, doctor, or nurse, the outer upper arm may also be used.

Injecting Xolair
Step 6. Clean the injection site
Wash your hands.
Clean the chosen injection site with an alcohol swab. Allow it to dry before injecting.
Do not touch or blow on the cleaned skin before injection.

Step 7. Remove the needle cap
Firmly pull to remove the needle cap from the pre-filled syringe. A drop of liquid at the tip of the needle may be visible. This is normal.
Do not replace the needle cap. Discard the needle cap.

Step 8. Insert the needle
Gently pinch the skin at the injection site and maintain the pinch throughout the injection. With the other hand, insert the needle into the skin at an angle of approximately 45 degrees, as shown.
Do not press the plunger while inserting the needle.

Step 9. Begin the injection
Continue pinching the skin. Slowly push the plunger all the way down. This delivers the full dose.

Step 10. Complete the injection
Ensure that the plunger tip is between the safety shield wings, as shown. This allows the safety shield to activate and cover the needle after the injection is complete.

Step 11. Release the plunger
While keeping the pre-filled syringe in the injection site, slowly release the plunger until the safety shield automatically covers the needle. Remove the syringe from the injection site and release the skin pinch.
There may be a small amount of bleeding at the injection site. You may press a cotton ball or gauze pad over the injection site until bleeding stops. Do not rub the injection site. If needed, cover the injection site with a small adhesive bandage.
Note: If more than one pre-filled syringe is needed to administer the full dose, discard the used syringe as described in Step 12.
Repeat Steps 2 through 12 for each pre-filled syringe required to administer the full dose.
Perform the injections immediately one after the other.
Ensure that the injections are at least 2 cm apart from each other.

After the injection
Step 12. Dispose of the pre-filled syringe
Place the pre-filled syringe into a sharps disposal container (i.e., a puncture-resistant, closable container) immediately after use.
Do not attempt to replace the needle cap on the syringe.
Ask your doctor or pharmacist how to properly dispose of the sharps container. There may be local regulations for disposal.

Package leaflet: Information for the user

Xolair 150 mg solution for injectable use in pre-filled pen, 300 mg solution for injectable use in pre-filled pen

omalizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Xolair is and what it is used for
2. What you need to know before using Xolair
3. How to use Xolair
4. Possible side effects
5. How to store Xolair
6. Contents of the pack and other information

1. What Xolair is and what it is used for

Xolair contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
natural proteins produced by the body. It belongs to a class of medicines called monoclonal
antibodies.
Xolair is used to treat:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps
• chronic spontaneous urticaria (CSU)

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of severe allergic asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma medications, but in whom asthma symptoms are not well controlled with medications such as high-dose inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age) who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but in whom symptoms are not well controlled with these medicines. Nasal polyps are small growths on the mucous membrane of the nose. Xolair helps reduce the size of nasal polyps and improves symptoms, including nasal congestion, loss of smell, mucus in the back of the throat, and runny nose.
Chronic spontaneous urticaria (CSU)
This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (from 12 years of age) who are already taking antihistamines, but whose CSU symptoms are not well controlled with these medicines.
Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the
body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma, chronic rhinosinusitis with nasal polyps, and CSU.

2. What you should know before using Xolair

Do not use Xolair

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic to any of the ingredients, inform your doctor as you must not use Xolair.

Warnings and precautions
Talk to your doctor before using Xolair:

• if you have problems with your kidneys or liver
• if you have a disorder in which your immune system attacks part of your body (autoimmune disease)
• if you plan to travel to areas where infections caused by parasites are common, because Xolair may reduce your resistance to these infections.
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, following a medicine, an insect sting, or food.

Xolair does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Xolair must not be used to treat these symptoms.
Do not use Xolair to prevent or treat other allergic conditions such as sudden allergic reactions, hyperimmunoglobulinemia E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease), food allergy, eczema, or hay fever, because Xolair has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious side effects
Xolair may potentially cause serious side effects. You should be alert for signs of these conditions while using Xolair. Seek immediate medical help if you notice any sign of a serious allergic reaction or other serious side effects. These signs are listed in section 4 under "Serious side effects".
Before you self-inject Xolair or before someone who is not a healthcare professional administers the injection, it is important that you receive instructions from your doctor on how to recognize early symptoms of severe allergic reactions and how to manage these reactions if they occur (see section 3, "How to use Xolair"). Most severe allergic reactions occur within the first 3 doses of Xolair.
Children and adolescents
Allergic asthma
Xolair is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Xolair is not recommended for children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Chronic spontaneous urticaria (CSU)
Xolair is not recommended for children under 12 years of age. Use in children under 12 years has not been studied.
Other medicines and Xolair
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines for the treatment of an infection caused by a parasite, as Xolair may reduce the effectiveness of these medicines,
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning a pregnancy, ask your doctor for advice before using this medicine. Your doctor will discuss with you the benefits and potential risks of using this medicine during pregnancy.
If you become pregnant while being treated with Xolair, inform your doctor immediately.
Xolair may pass into breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice before using this medicine.
Driving and using machines
It is unlikely that Xolair will affect your ability to drive or operate machinery.

3. How to use Xolair

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.
How Xolair is used
Xolair is administered as an injection under the skin (known as a subcutaneous injection).
Xolair injection

• You and your doctor will decide whether you can self-inject Xolair. The first 3 doses are always administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained in how to inject the medicine before giving yourself an injection.
• A person assisting you (e.g. a family member) may also administer the Xolair injection after receiving appropriate training.

For detailed instructions on how to inject Xolair, see “Instructions for use of the Xolair pre-filled pen” at the end of this leaflet.
Instructions on how to recognize serious allergic reactions
It is also important that you do not self-inject Xolair until you have been trained by your doctor or nurse on:

• how to recognize the early signs and symptoms of a serious allergic reaction;
• what to do if symptoms occur. For further information on the early signs and symptoms of serious allergic reactions, see section 4.

Dosage
Allergic asthma and chronic rhinosinusitis with nasal polyps
Your doctor will determine the dose of Xolair you need and how often you should use it. This depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE level in the blood.
You will need 1 to 3 injections at a time. You will require injections every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Xolair. Do not stop taking your asthma and/or nasal polyps medication without first consulting your doctor.
You may not notice immediate improvement after starting Xolair treatment. In patients with nasal polyps, effects become apparent after 4 weeks of starting treatment. In asthmatic patients, full effect is usually achieved after 12–16 weeks.
Chronic spontaneous urticaria (CSU)
Two injections of 150 mg each at a time or one injection of 300 mg every four weeks will be required.
Continue taking your current medication for CSU during treatment with Xolair. Do not stop taking your medication without consulting your doctor.
Use in children and adolescents
Allergic asthma
Xolair may be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled by high-dose inhaled corticosteroids and inhaled beta agonists. Your doctor will determine the amount of Xolair the child needs and how often it should be administered. This will depend on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s IgE level in the blood.
Self-administration of Xolair is not intended for children (aged 6 to 11 years).
However, if your doctor considers it appropriate, Xolair injections may be given by a caregiver after receiving adequate training.
Xolair pre-filled pens must not be used in children under 12 years of age. In children aged 6 to 11 years with allergic asthma, Xolair 75 mg pre-filled syringe, Xolair 150 mg pre-filled syringe, or Xolair powder and solvent for injectable solution may be used.
Chronic rhinosinusitis with nasal polyps
Xolair must not be used in children and adolescents under 18 years of age.
Chronic spontaneous urticaria (CSU)
Xolair may be used in adolescents aged 12 years and older who are already taking antihistamines but whose CSU symptoms are not well controlled by these medications. The dose for adolescents aged 12 years and older is the same as for adults.
If you miss a dose of Xolair
If you miss an appointment, contact your doctor or hospital as soon as possible to schedule a new one.
If you forget to administer a dose of Xolair, inject the missed dose as soon as you remember. Then contact your doctor to determine when you should administer the next dose.
If you stop treatment with Xolair
Do not stop treatment with Xolair unless your doctor tells you to. Stopping or discontinuing treatment with Xolair may cause symptoms to return.
However, if you are being treated for CSU, your doctor may temporarily discontinue Xolair treatment from time to time to assess your symptoms. Follow your doctor’s instructions.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects caused by Xolair are usually mild or moderate in severity, but occasionally they can be serious.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical help:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Xolair, you may have an increased risk of developing a severe allergic reaction after using Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood or lymph vessels, high levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, tingling in arms and legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• reactions at the injection site such as pain, swelling, itching and redness
• pain in the upper abdomen
• headache (very common in children)
• upper respiratory tract infections such as pharyngitis and common cold
• feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache)
• joint pain (arthralgia)
• dizziness

Uncommon (may affect up to 1 in 100 people)

• feeling sleepy or tired
• tingling or numbness in hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute breathing problems
• feeling unwell (nausea), diarrhoea, indigestion
• itching, hives, rash, increased sensitivity of the skin to sunlight
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known (frequency cannot be estimated from the available data)

• muscle pain and joint swelling
• hair loss

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xolair

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Prior to use, the carton containing the pre-filled pen may be stored for a total period of 48 hours at room temperature (25°C). Store in the original packaging to protect the medicine from light. Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use if the packaging is damaged or shows any signs of tampering.

6. Package contents and other information

What Xolair contains

• The active substance is omalizumab.
• A 1 mL pre-filled pen contains 150 mg of omalizumab.
• A 2 mL pre-filled pen contains 300 mg of omalizumab.
• The other components are arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, and water for injections.

Description of the appearance of Xolair and contents of the pack
Xolair injectable solution is a clear or slightly opalescent solution, colourless to pale yellowish-brown, contained in a pre-filled pen.
Xolair 150 mg injectable solution in a pre-filled pen is available in packs containing 1 pre-filled pen and in multiple packs containing 3 (3 x 1), 6 (6 x 1), or 10 (10 x 1) pre-filled pens.
Xolair 300 mg injectable solution in a pre-filled pen is available in packs containing 1 pre-filled pen and in multiple packs containing 3 (3 x 1) or 6 (6 x 1) pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF XOLAIR PRE-FILLED PEN

These “Instructions for Use” contain information on how to inject Xolair.
If your doctor decides that you or a caregiver may administer the Xolair injection at home, make sure your doctor or nurse shows you or the caregiver how to prepare and administer the injection using the Xolair pre-filled pen before using it for the first time.
The Xolair pre-filled pen is intended for patients aged 12 years and older.
Make sure you have read and understood these “Instructions for Use” before administering the injection with the

Xolair pre-filled pen. If you have any questions, consult your doctor.

Before use After use
xx mg xx mg
Label of the
Xolair
Xolair
device,
with brand name,
dosage and expiration date
Observation window
Green indicator
Cap
Cover cap
Protected needle inside
Important information you must know before injecting Xolair

• Xolair is for subcutaneous injection only (injection directly into the fatty layer under the skin).
• Do not use the pen if the seal on the carton is broken.
• Do not use if the pen has been dropped after removing the cap.
• Do not use if the pen has been out of the refrigerator for a total time exceeding 48 hours. Dispose of it (see Step 13) and use a new pen for the injection.
• Do not touch or press the cover cap as you may injure yourself. Touching or pressing the cover cap may result in needle-stick injuries.
• Do not attempt to reuse or disassemble the pen.
• Do not attempt to re-cap the pen after removing the cap.

How to store Xolair

• Store in a refrigerator (2°C to 6°C). Before use, the carton containing the pen may be stored at room temperature (25°C) for a total of up to 48 hours.
• Do not freeze.
• Keep the pen in its original packaging until use to protect it from light.
• Keep the pen out of the sight and reach of children.

DOSING TABLE
Xolair pens are available in 3 dosage strengths (one pen per carton). These instructions apply to all 3 dosage strengths.
Depending on the dose prescribed by your doctor, you will need to select one or more pens and inject all of their contents to administer the full dose. The Dosing Table below shows the pen combinations required to deliver the full dose.
If you have any doubts about the Dosing Table, consult your doctor.

Xolair 75 mg Xolair 150 mg
Xolair 300 mg
pen with blue cover cap pen with purple cover cap pen with grey cover cap
Blue cover cap Purple cover cap Grey cover cap
Dose Number of pens required Blue Purple Grey
for dose 75 mg 150 mg 300 mg
75 mg 1 blue
150 mg 1 purple
225 mg 1 blue + 1 purple
300 mg 1 grey
375 mg 1 blue + 1 grey
450 mg 1 purple + 1 grey
525 mg 1 blue + 1 purple + 1 grey
600 mg 1 grey + 1 grey
Preparing to inject Xolair
Step 1. Bring to room temperature
Remove the carton containing the pen from the
refrigerator, do not open it, and allow it to reach
room temperature (for at least 30 minutes).
Note: If more than one pen (each carton contains one pen) is needed to administer the full dose (see Dosing Table), remove all cartons from the refrigerator at the same time.
Step 2. Prepare supplies for injection
You will need the following items (not included
in the carton):

• alcohol swab
• cotton ball or gauze pad
• sharps disposal container
• adhesive bandage

Step 3. Remove the pen

Remove the pen from the carton.
Do not remove the cap until just before injection.
Step 4. Examine the pen

Look through the observation window of the pen.
The liquid inside should be clear to slightly
cloudy. The color may range from colorless to
pale yellow-brown. Air bubbles in the liquid are
normal.

• Do not use the pen if the liquid contains particles or if it is clearly cloudy or clearly brown.
• Do not use the pen if it appears damaged.
• Do not use the pen after the expiration date printed on the label (EXP) and on the carton (Scad.).

In any of these cases, consult your doctor,
nurse, or pharmacist.
Expiration date
Step 5. Choose the injection site

The injection should be given in the front of the thighs or the lower abdomen, but not within 5 centimeters of the navel.
Do not inject where the skin is tender, damaged, red, scaly, hard, or in areas with scars or stretch marks.
Note: If more than one pre-filled pen is needed to achieve the full dose, administer the injections at least 2 cm apart from each other.
If the injection is administered by a caregiver,
your doctor, or a nurse, the outer upper arm may
also be used.

Injecting Xolair
Step 6. Clean the injection site
Wash your hands.
Clean the chosen injection site with an alcohol swab. Allow it to dry before injecting.
Do not touch or blow on the cleaned skin before injecting.
Step 7. Remove the cap

Firmly pull the cap off in the direction of the arrow.
Do not re-cap the pen. Discard the cap.
Step 8. Position the pen

Hold the pen comfortably with the cover cap
pressed directly against the skin.
The pen should be at a 90° angle to the skin, as shown.
Step 9. Start the injection

Firmly press and hold the pen against the skin.
You will hear the 1st click, indicating the start of the injection.
1st CLICK
Step 10. Monitor the injection

Continue to firmly hold the pen pressed against the skin. The green indicator shows the progress of the injection.
Step 11. Complete the injection

You will hear the 2nd click, indicating that the injection is almost complete.
2nd CLICK
Continue to hold the pen in place
until the green indicator stops moving, to ensure the injection is complete. Remove the pen from the skin.
The needle is automatically covered by the cover cap. The injection is now complete.
After the injection
Step 12. Check the green indicator

If the green indicator has not completely filled the observation window, consult your doctor or nurse.
There may be a small amount of bleeding at the injection site.
You may press a cotton ball or gauze pad over the injection site until bleeding stops.
Do not rub the injection site. If needed, cover the injection site with a small adhesive bandage.
Note: If more than one pen is required to administer the full dose, dispose of the used pen as described in Step 13.
Repeat Steps 2 through 13 for each pen needed to administer the full dose.
Perform the injections immediately one after the other.
Ensure that the injections are at least 2 cm apart from each other.
Step 13. Dispose of the pen
Place the used pen immediately after use into a sharps disposal container (i.e., a closable, puncture-resistant container).
Ask your doctor or pharmacist how to properly dispose of the sharps container. Local regulations for disposal may apply.

Patient Information Leaflet: Information for the User

Xolair 75 mg powder and solvent for injectable solution

omalizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Xolair is and what it is used for
2. What you need to know before receiving Xolair
3. How Xolair is administered
4. Possible side effects
5. How to store Xolair
6. Contents of the pack and other information

1. What is Xolair and what is it used for?

Xolair contains the active substance omalizumab. Omalizumab is a synthetic protein similar to the
natural proteins produced by the body. It belongs to a class of medicines called monoclonal antibodies.
Xolair is used for the treatment of:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of moderate to severe allergic asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma medications, but in whom asthma symptoms are not well controlled with medications such as high-dose inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age) who are already receiving intranasal corticosteroids (nasal spray containing corticosteroids), but in whom symptoms are not well controlled with these medications. Nasal polyps are small growths on the lining of the nose. Xolair helps reduce the size of nasal polyps and improves symptoms, including nasal congestion, loss of sense of smell, mucus in the back of the throat, and runny nose.
Xolair works by blocking a substance known as immunoglobulin E (IgE), which is produced by the
body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and chronic rhinosinusitis with nasal polyps.

2. What you need to know before being given Xolair

Do not be given Xolair

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of the ingredients, inform your doctor, as Xolair must not be administered to you.

Warnings and precautions
Talk to your doctor before being given Xolair:

• if you have kidney or liver problems;
• if you have a disorder in which your immune system attacks part of your body (autoimmune disease);
• if you plan to travel to areas where infections caused by parasites are common, as Xolair may reduce your resistance to these infections;
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, to a medicine, an insect sting, or food.

Xolair does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Xolair must not be used to treat these symptoms.
Do not use Xolair to prevent or treat other allergic conditions such as sudden allergic reactions, hyperimmunoglobulinemia E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease), food allergy, eczema, or hay fever, as Xolair has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious adverse effects
Xolair may potentially cause serious adverse effects. You should be alert for signs of these conditions while using Xolair. Seek immediate medical help if you notice any sign of a possible severe allergic reaction. These signs are listed in section 4 under “Serious adverse reactions”. Most severe allergic reactions occur within the first 3 doses of Xolair.
Children and adolescents
Allergic asthma
Xolair is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Xolair is not recommended for children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Other medicines and Xolair
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines for the treatment of a parasitic infection, as Xolair may reduce the effectiveness of these medicines;
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine. Your doctor will discuss with you the benefits and potential risks of administering this medicine during pregnancy.
If you become pregnant while being treated with Xolair, inform your doctor immediately.
Xolair may pass into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.
Driving and using machines
It is unlikely that Xolair will affect your ability to drive or operate machinery.

3. How Xolair is administered

Instructions on how to use Xolair are provided in the section “Information for healthcare professionals”.
Xolair is administered to you by a doctor or nurse as a subcutaneous injection.
Carefully follow the instructions given by your doctor or nurse.
Dose administered
Your doctor will determine the dose of Xolair you need and how often it should be administered.
This depends on your body weight and the results of a blood test performed before starting treatment to measure the level of IgE in your blood.
You will receive from 1 to 4 injections at a time, every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Xolair. Do not stop taking your asthma and/or nasal polyps medications without consulting your doctor.
You may not notice immediate improvement after starting Xolair treatment. In patients with nasal polyps, effects become evident after 4 weeks of starting treatment. In asthmatic patients, full effect is usually achieved after 12–16 weeks.
Use in children and adolescents
Allergic asthma
Xolair can be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled by high-dose inhaled corticosteroids and inhaled beta agonists. Your doctor will determine the amount of Xolair the child needs and how often it should be given. This will depend on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s IgE blood level.
Chronic rhinosinusitis with nasal polyps
Xolair must not be used in children and adolescents under 18 years of age.
If you have missed a dose of Xolair
Contact your doctor or hospital as soon as possible to schedule a new appointment.
If you stop treatment with Xolair
Do not stop treatment with Xolair unless your doctor tells you to. Stopping or discontinuing treatment with Xolair may cause symptoms to return.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects caused by Xolair are usually mild or moderate, but occasionally they can be severe.

Serious side effects:
If you notice any of the symptoms listed below, seek immediate medical help:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Xolair, you may have an increased risk of developing a severe allergic reaction after using Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood vessels or lymphatic vessels, high levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• reactions at the injection site such as pain, swelling, itching and redness
• pain in the upper part of the stomach
• headache (very common in children)
• feeling dizzy
• joint pain (arthralgia)

Uncommon (may affect up to 1 in 100 people)

• feeling drowsy or tired
• tingling or numbness in the hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute respiratory problems
• feeling unwell (nausea), diarrhoea, indigestion
• itching, hives, rash, increased sensitivity of the skin to sunlight
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known: frequency cannot be estimated from the available data

• muscle pain and joint swelling
• hair loss

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xolair

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The
expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.

6. Package contents and other information

What Xolair contains

• The active substance is omalizumab. One vial contains 75 mg of omalizumab. After reconstitution, one vial contains 125 mg/mL of omalizumab (75 mg in 0.6 mL).
• The other components are sucrose, histidine, monohydrochloride monohydrate histidine, polysorbate 20.

Description of the appearance of Xolair and contents of the pack
Xolair 75 mg powder and solvent for solution for injection is supplied as a white to off-white powder
in a small glass vial together with a vial containing 2 mL of water for injections. Before being injected by a doctor or nurse, the powder is reconstituted
with the water.
Xolair is available in packs containing one vial of powder for solution for injection and one
vial with 2 mL of water for injections.
Xolair is also available in vials containing 150 mg of omalizumab.
Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information about this medicinal product, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaa Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/
INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended exclusively for healthcare professionals:
The lyophilized medicine requires 15–20 minutes for dissolution, although in some cases a longer time may be needed. The fully reconstituted medicine appears from clear to slightly opalescent, colourless to pale yellow-brown, and may contain small bubbles or foam around the edge of the vial. Due to the viscosity of the reconstituted medicine, care must be taken to withdraw all the medicine from the vial before expelling any air or excess solution from the syringe, in order to obtain 0.6 mL.
To prepare vials of Xolair 75 mg for subcutaneous administration, follow the instructions below:

1. Draw up 0.9 mL of water for injections from the vial into a syringe fitted with a large-bore 18-gauge needle.
2. With the vial held upright on a flat surface, insert the needle and transfer the water for injections into the vial containing the lyophilized powder, following standard sterile techniques, directing the water for injections directly onto the powder.
3. Holding the vial upright, vigorously invert it (do not shake) repeatedly for about 1 minute to uniformly wet the powder.
4. To facilitate dissolution, after completing step 3, gently invert the vial for 5–10 seconds approximately every 5 minutes to dissolve any remaining solid particles.

Note that in some cases more than 20 minutes may be required for the powder to dissolve completely. In such cases, repeat step 4 until no gel-like particles are visible in the solution.
When the medicine is completely dissolved, no gel-like particles should be visible in the solution. Small bubbles or foam around the edge of the vial are common. The reconstituted medicine will appear from clear to slightly opalescent, colourless to pale yellow-brown. Do not use if solid particles are present.

5. Invert the vial for at least 15 seconds to allow the solution to flow toward the stopper. Using a new 3 mL syringe fitted with a large-bore 18-gauge needle, insert the needle into the inverted vial. While holding the vial inverted, position the tip of the needle at the bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull back fully on the plunger to the end of the syringe barrel to withdraw all solution from the inverted vial.
6. Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
7. Expel air, larger bubbles, and any excess solution to obtain the required 0.6 mL solution. A thin layer of small bubbles at the top of the solution in the syringe may remain. Because the solution is slightly viscous, administration of the solution by subcutaneous injection may take 5–10 seconds.

The vial provides 0.6 mL (75 mg) of Xolair.

8. Injections are administered subcutaneously in the deltoid region of the arm, the lower abdomen (but not within the 5 cm area around the umbilicus), or the thigh.

Package leaflet: Information for the user

Xolair 150 mg powder and solvent for injectable solution

omalizumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Xolair is and what it is used for
2. What you need to know before receiving Xolair
3. How Xolair is administered
4. Possible side effects
5. How to store Xolair
6. Package contents and other information

1. What Xolair is and what it is used for

Xolair contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
proteins naturally produced by the body. It belongs to a class of medicines called monoclonal
antibodies.
Xolair is used to treat:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps
• chronic spontaneous urticaria (CSU)

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of moderate to severe
allergic asthma in adults, adolescents, and children (from 6 years of age) who are already receiving
asthma medications, but whose asthma symptoms are not well controlled with medications such as
high-dose inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age)
who are already receiving intranasal corticosteroids (corticosteroid nasal spray), but whose symptoms
are not well controlled with these medicines. Nasal polyps are small growths on the lining of the nose.
Xolair helps reduce the size of nasal polyps and improves symptoms, including nasal congestion, loss
of sense of smell, mucus in the back of the throat, and runny nose.
Chronic spontaneous urticaria (CSU)
This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (from 12 years of
age) who are already taking antihistamines, but whose CSU symptoms are not well controlled with
these medicines.
Xolair works by blocking a substance known as immunoglobulin E (IgE), which is produced by the
body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma, chronic
rhinosinusitis with nasal polyps, and CSU.

2. What you should know before being given Xolair

Do not take Xolair

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic to any of the ingredients, tell your doctor, as Xolair must not be given to you.

Warnings and precautions
Talk to your doctor before being given Xolair:

• if you have kidney or liver problems;
• if you have a condition in which your immune system attacks part of your body (autoimmune disease);
• if you plan to travel to areas where infections caused by parasites are common, because Xolair may reduce your resistance to these infections;
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, following a medicine, insect sting, or food.

Xolair does not treat acute asthma symptoms such as sudden asthma attacks. Therefore, Xolair must not be used to treat these symptoms.
Do not use Xolair to prevent or treat other allergic conditions such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease), food allergy, eczema, or hay fever, as Xolair has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious side effects
Xolair may potentially cause serious side effects. You should be aware of the signs of these conditions while using Xolair. Seek immediate medical help if you notice any signs of a possible serious allergic reaction. These signs are listed in section 4 under “Serious side effects”. Most serious allergic reactions occur within the first 3 doses of Xolair.
Children and adolescents
Allergic asthma
Xolair is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Xolair is not recommended for children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Chronic spontaneous urticaria (CSU)
Xolair is not recommended for children under 12 years of age. Use in children under 12 years has not been studied.
Other medicines and Xolair
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines used to treat a parasitic infection, as Xolair may reduce the effectiveness of these medicines,
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine. Your doctor will discuss with you the benefits and potential risks of using this medicine during pregnancy.
If you become pregnant while being treated with Xolair, inform your doctor immediately.
Xolair may pass into breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice before using this medicine.
Driving and using machines
It is unlikely that Xolair will affect your ability to drive or operate machinery.

3. How Xolair is administered

Instructions on how to use Xolair are provided in the section “Information for healthcare professionals”.
Xolair is administered to you by a doctor or nurse as a subcutaneous injection.
Carefully follow the instructions given by your doctor or nurse.

Dosage administered
Allergic asthma and chronic rhinosinusitis with nasal polyps
Your doctor will determine the dose of Xolair you need and how often it will be administered.
This depends on your body weight and the results of a blood test performed before starting treatment to measure your blood IgE levels.
You will receive from 1 to 4 injections at a time, either every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Xolair. Do not stop taking your asthma and/or nasal polyps medication without consulting your doctor.
You may not notice an immediate improvement after starting Xolair treatment. In patients with nasal polyps, effects are seen after 4 weeks from the start of treatment. In asthmatic patients, full effect is usually achieved after 12–16 weeks.

Chronic spontaneous urticaria (CSU)
You will receive two 150 mg injections at a time every four weeks.
Continue taking your current medication for CSU during treatment with Xolair. Do not stop taking any medication without consulting your doctor.

Use in children and adolescents
Allergic asthma
Xolair can be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled by high-dose inhaled corticosteroids and inhaled beta agonists. Your doctor will determine the amount of Xolair the child needs and how often it should be administered. This depends on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s blood IgE levels.

Chronic rhinosinusitis with nasal polyps
Xolair must not be used in children and adolescents under 18 years of age.

Chronic spontaneous urticaria (CSU)
Xolair can be used in adolescents aged 12 years and older who are already taking antihistamines but whose CSU symptoms are not well controlled by these medications. The dose for adolescents aged 12 years and older is the same as for adults.

If you miss a dose of Xolair
Contact your doctor or hospital as soon as possible to schedule a new appointment.

If you stop treatment with Xolair
Do not stop treatment with Xolair unless your doctor tells you to do so. Stopping or interrupting treatment with Xolair may cause symptoms to return.
However, if you are being treated for CSU, your doctor may temporarily interrupt Xolair treatment from time to time to assess your symptoms. Follow your doctor’s instructions.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects caused by Xolair are usually mild or moderate in severity, but occasionally they can be serious.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical help:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) unrelated to Xolair, you may have a higher risk of developing a severe allergic reaction after using Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss and fatigue.

Not known (frequency cannot be estimated from available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood vessels or lymphatic vessels, elevated levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness or tingling in arms and legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• reactions at the injection site such as pain, swelling, itching and redness
• pain in the upper abdomen
• headache (very common in children)
• upper respiratory tract infections such as pharyngitis and common cold
• feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache)
• joint pain (arthralgia)
• dizziness

Uncommon (may affect up to 1 in 100 people)

• feeling sleepy or tired
• tingling or numbness in the hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute breathing problems
• feeling unwell (nausea), diarrhea, indigestion
• itching, hives, rash, increased sensitivity of the skin to sunlight
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known: frequency cannot be estimated from available data

• muscle pain and joint swelling
• hair loss

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xolair

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.

6. Package contents and other information

What Xolair contains

• The active substance is omalizumab. One vial contains 150 mg of omalizumab. After reconstitution, one vial contains 125 mg/mL of omalizumab (150 mg in 1.2 mL).
• The other ingredients are sucrose, histidine, monohydrochloride monohydrate of histidine, polysorbate 20.

Description of the appearance of Xolair and contents of the pack
Xolair 150 mg powder and solvent for solution for injection is supplied as a white to off-white
powder in a small glass vial together with a vial containing 2 mL of water for injections.
Before being injected by a doctor or nurse, the powder is reconstituted with the water.
Xolair 150 mg powder and solvent for solution for injection is available in packs containing
1 vial of powder for solution for injection and 1 vial with 2 mL of water for injections, and in
multiple packs containing 4 (4 x 1) vials of powder and 4 (4 x 1) vials of water for injections or
10 (10 x 1) vials of powder and 10 (10 x 1) vials of water for injections.
Not all pack sizes may be marketed.
Xolair is also available in vials containing 75 mg of omalizumab.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended exclusively for healthcare professionals:
The lyophilized medicine requires 15–20 minutes for dissolution, although in some cases a longer time may be needed. The fully reconstituted medicine appears clear to slightly opalescent, colourless to pale yellow-brown, and may contain small bubbles or foam around the edge of the vial. Due to the viscosity of the reconstituted medicine, care should be taken to withdraw all of the medicine from the vial before expelling any air or excess solution from the syringe, in order to obtain 1.2 mL.

To prepare vials of Xolair 150 mg for subcutaneous administration, follow the instructions below:

1. Draw up 1.4 mL of water for injections from the vial into a syringe fitted with a large-bore 18-gauge needle.
2. With the vial held upright on a flat surface, insert the needle and transfer the water for injections into the vial containing the lyophilized powder, using standard sterile techniques, directing the water directly onto the powder.
3. Holding the vial upright, vigorously invert (do not shake) repeatedly for about 1 minute to uniformly wet the powder.
4. To aid dissolution, after completing step 3, gently invert the vial for 5–10 seconds approximately every 5 minutes to dissolve any remaining solid particles.

Note that in some cases more than 20 minutes may be required for the powder to dissolve completely. In such cases, repeat step 4 until no gel-like particles are visible in the solution.
When the medicine is completely dissolved, no gel-like particles should be visible in the solution. Small bubbles or foam around the edge of the vial are common. The reconstituted medicine will appear clear to slightly opalescent, colourless to pale yellow-brown. Do not use if solid particles are present.

5. Invert the vial for at least 15 seconds to allow the solution to flow towards the stopper. Using a new 3 mL syringe fitted with a large-bore 18-gauge needle, insert the needle into the inverted vial. While holding the vial inverted, place the tip of the needle at the bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, fully pull back the plunger to the end of the syringe barrel to withdraw all solution from the inverted vial.
6. Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
7. Expel air, larger bubbles, and any excess solution to achieve the required 1.2 mL solution. A thin layer of small bubbles at the top of the solution in the syringe may remain. Because the solution is slightly viscous, administration by subcutaneous injection may take 5–10 seconds.

The vial provides 0.6 mL (75 mg) of Xolair. For a 75 mg dose, draw up 0.6 mL into a syringe and discard the remaining solution.

8. Injections are administered subcutaneously in the deltoid region of the arm, the lower abdomen (but not within 5 cm around the umbilicus), or the thigh.