Xolair 150 mg solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Xolair 150mg solution for injection in pre-filled syringe

(pre-filled syringe with fixed 26-gauge needle, purple syringe protector)

omalizumab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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 human 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 sinuses) with nasal polyps
• chronic spontaneous urticaria (CSU)

Allergic asthma

This medicine is used to prevent worsening of asthma by controlling the symptoms of severe allergic asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma medications, but whose symptoms are not adequately 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 receiving intranasal corticosteroids (nasal corticosteroid spray), but whose symptoms are not well controlled with these medications. Nasal polyps are small growths in the lining of the nose. Xolair helps reduce the size of nasal polyps and improves symptoms including nasal congestion, loss of smell, postnasal drip, 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 receiving antihistamines but whose CSU symptoms are not well controlled by these medications.

Xolair works by blocking a substance called immunoglobulin E (IgE) that is produced by the body. IgE is involved in 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 own immune system attacks parts of your body (autoimmune disease),
• if you are travelling to an area where parasitic infections are common, as Xolair may reduce your resistance to such 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 had an allergic reaction to latex. The needle cap of the syringe may contain dry rubber (latex).

Xolair does not treat symptoms of acute asthma, such as a sudden asthma attack. Therefore, Xolair should not be used to treat this type of symptom.

Xolair is not intended to prevent or treat other allergic-type conditions such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a lung disease caused by a fungus), food allergy, eczema, or hay fever, as Xolair has not been studied in these conditions.

Watch for signs of allergic reactions and other serious adverse effects

Xolair may cause serious adverse effects. You should monitor for signs of these effects while using Xolair. Seek medical help immediately if you notice any signs indicating a severe allergic reaction or other serious adverse effects. These signs are described under “Serious adverse reactions” in section 4.

Before you or someone else (not a healthcare professional) injects Xolair, it is important that you receive training from your doctor on how to recognize early symptoms of severe allergic reactions and how to respond if they occur (see section 3, “How to use Xolair”). Most severe allergic reactions occur during the first three doses of Xolair.

Children and adolescents

Allergic asthma

Xolair is not recommended for children under 6 years of age. Its use has not been studied in children under 6 years of age.

Chronic rhinosinusitis with nasal polyps

Xolair is not recommended for children and adolescents under 18 years of age. Its use has not been studied in patients under 18 years of age.

Chronic spontaneous urticaria (CSU)

Xolair is not recommended for children under 12 years of age. Its use has not been studied in children under 12 years of age.

Other medicines and Xolair

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

This is especially important if you are taking:

• medicines 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 plan to become pregnant, talk to your doctor before using this medicine. Your doctor will discuss with you the potential benefits and risks of using this medicine during pregnancy.

Tell your doctor immediately if you become pregnant while being treated with Xolair.

Xolair may pass into breast milk. If you are breastfeeding or plan to breastfeed, talk to your doctor before using this medicine.

Driving and using machines

It is unlikely that Xolair will affect your ability to drive or use machines.

3. How to use Xolair

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

How Xolair is used

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

Xolair injection

• You and your doctor will decide whether you will self-inject Xolair. The first three doses are always administered under the supervision of a healthcare professional (see section 2).

• It is important that you have received proper training on how to inject the medicine yourself before doing so.

• A caregiver (for example, parents) may administer the Xolair injection after receiving appropriate training.

For detailed instructions on how to inject Xolair, see “Instructions for use of Xolair in prefilled syringe” at the end of this leaflet.

Training for recognizing severe allergic reactions

It is also important that you do not self-inject Xolair until your doctor or nurse has taught you:

• how to recognize the early signs and symptoms of severe allergic reactions,
• what to do if symptoms occur.

For more information about the 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 it should be administered. This depends on your body weight and the results of a blood test performed before starting treatment to determine the concentration of IgE in your blood.

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

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

You may not notice immediate improvement after starting treatment with Xolair. In patients with nasal polyps, effects have been observed 4 weeks after starting treatment. In patients with asthma, it generally takes between 12 and 16 weeks for the medicine to achieve its full effect.

Chronic spontaneous urticaria (CSU)

You will need two 150 mg injections at the same time every four weeks.

Continue taking your current medication for CSU during treatment with Xolair. Do not stop 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 receiving asthma medication but whose asthma symptoms are not well controlled by medications such as high-dose inhaled corticosteroids and inhaled beta-agonists. Your doctor will inform you about the dose of Xolair your child needs and how often it should be administered. This will depend on the child's body weight and the results of blood tests performed before starting treatment to determine the level of IgE in their blood.

Children (aged 6 to 11 years) are not expected to self-inject Xolair. However, if considered appropriate by the doctor, a caregiver may administer the injection 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 receiving 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 forget a dose of Xolair

If you miss an appointment, contact your doctor or hospital as soon as possible to reschedule.

If you forget to self-inject a dose of Xolair, inject it as soon as you remember. Then consult your doctor to determine when the next dose should be administered.

If you stop treatment with Xolair

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

However, if you are being treated for CSU, your doctor may occasionally stop treatment with Xolair to assess your symptoms. Follow your doctor's instructions.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Adverse effects caused by Xolair are generally mild to moderate, but occasionally they may be serious.

Serious adverse effects:

Seek immediate medical attention if you notice any of the signs of the following adverse effects:

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

• Severe allergic reactions (including anaphylaxis). Symptoms may include rash, itching, hives, swelling of the face, lips, tongue, larynx (voice box), trachea, or other parts of the body, rapid heartbeat, dizziness and mild light-headedness, confusion, shortness of breath, wheezing or difficulty breathing, bluish skin or lips, collapse, and 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 after using Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.

Frequency not known (cannot be estimated from available data)

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

Other adverse effects include:

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

• fever (in children)

Common (may affect up to 1 in 10 patients)

• injection site reactions including pain, swelling, itching, and redness
• upper abdominal pain
• 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 patients)

• 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
• nausea, diarrhea, indigestion
• itching, hives, rash, increased skin sensitivity to sunlight
• weight gain
• flu-like symptoms
• swollen arms

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

• parasitic infection

Frequency not known (cannot be estimated from available data)

• muscle pain and joint inflammation
• hair loss

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month indicated. The carton containing the pre-filled syringe may be stored for up to 48 hours at room temperature (25°C) prior to use.
• Store in the original packaging to protect from light.
• Store in a refrigerator (between 2°C and 8°C). Do not freeze.
• Do not use any container that is damaged or shows signs of deterioration.

6. Contents of the pack and other information

Composition of Xolair

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

Nature of the product and contents of the pack

Xolair solution for injection is presented as a solution ranging from clear to slightly opalescent, colourless to light brownish-yellow, in a pre-filled syringe.

Xolair 150 mg solution for injection in a pre-filled syringe with a fixed 26-gauge needle and a purple syringe cap is available in packs containing 1 pre-filled syringe and in multiple packs containing 4 (4 × 1), 6 (6 × 1), or 10 (10 × 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

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11	Lithuania SIA Novartis Baltics Lithuania branch Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Tel: +359 2 489 98 28	Luxembourg/Luxembourg Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11
Czech Republic Novartis s.r.o. Tel: +420 225 775 111	Hungary Novartis Hungária Kft. Tel.: +36 1 457 65 00
Denmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Germany Novartis Pharma GmbH Tel: +49 911 273 0	Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 111
Estonia SIA Novartis Baltics Estonia branch Tel: +372 66 30 810	Norway Novartis Norge AS Tlf: +47 23 05 20 00
Greece Novartis (Hellas) S.A.E. Tel: +30 210 281 17 12	Austria Novartis Pharma GmbH Tel: +43 1 86 6570
Spain Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Poland Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Croatia Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1	Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Cyprus Novartis Pharma Services Inc. Tel: +357 22 690 690	Sweden Novartis Sverige AB Tel: +46 8 732 32 00
Latvia SIA Novartis Baltics Tel: +371 67 887 070

Date of last review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

INSTRUCTIONS FOR USE OF XOLAIR PRE-FILLED SYRINGE

Read ALL instructions before injecting the medicine. If your doctor decides that you or your caregiver may administer your Xolair injections at home, you must receive training from your doctor, nurse, or pharmacist before you inject the medicine yourself or administer it to others. Children (6 to less than 12 years of age) are not expected to self-inject Xolair; however, if your doctor considers it appropriate, a caregiver may administer Xolair to them after receiving proper training. The pack contains the pre-filled syringe(s) of Xolair individually sealed in a plastic tray.

Your Xolair pre-filled syringe 150 mg solution for injection

Once the medicine has been injected, the syringe needle guard will automatically activate to cover the needle. This is designed to protect against injuries from accidental needle sticks.

What else you need for the injection:

Alcohol wipe. Cotton or gauze. Container for disposal of sharp objects.

Important safety information

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

• The needle cap of the syringe may contain dried rubber (latex), which should not be touched by individuals sensitive to this substance.
• Do not open the sealed carton until you are ready to use this medicine.
• Do not use this medicine if the carton seal or the plastic tray seal is broken, as it may not be safe to use.
• Do not use if the syringe has been dropped onto a hard surface or dropped after removing the needle cap.
• Never leave the syringe where others might handle it.
• Do not shake the syringe.
• Take great care not to touch the activation clips before use. Doing so may cause the needle shield to activate prematurely.
• Do not remove the needle cap until immediately before administering the injection.
• The syringe is not reusable. After use, dispose of the syringe in a sharps disposal container.

Storage of Xolair pre-filled syringe for injection

• Store this medicine sealed in its original carton to protect it from light. Store in a refrigerator between 2 °C and 8 °C. DO NOT FREEZE.
• Remember to remove the syringe from the refrigerator to allow it to reach room temperature (25 °C) before preparing the injection (this will take approximately 30 minutes). Leave the syringe in the carton to protect it from light. The total time the syringe may remain at room temperature (25 °C) before use must not exceed 48 hours.
• Do not use the syringe after the expiry date stated on the carton or syringe label. If expired, return the complete package to the pharmacy.

Injection site

The injection site is the location where you will use the syringe The recommended site is the upper thigh. The lower abdomen may also be used, but not within a 5 cm area around the navel (belly button). If more than one injection is needed for the full dose, select a different injection site each time. Do not inject into areas where the skin is tender, damaged, red, scaly, or hardened. Avoid areas with scars or stretch marks. If the injection is administered by a caregiver, the upper arm may also be used.

Preparation of Xolair Injectable Solution in Prefilled Syringe Ready to Use

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 of them. The following table provides examples of the number of injections of each concentration that you may need for a given dose:

1. Remove the box containing the syringe from the refrigerator and leave it unopened for approximately 30 minutes, until it reaches room temperature (keep the syringe inside the box to protect it from light).
2. When ready to use the syringe, wash your hands thoroughly with soap and water.
3. Properly disinfect the injection site with an alcohol wipe.
4. Remove the plastic tray from the box and peel off the paper covering it. Hold the syringe by the middle of its blue protector and remove the syringe from the tray.
5. Inspect the syringe. The liquid should be from clear to slightly cloudy. Its color may vary from colorless to pale yellowish-brown. Small air bubbles are normal. DO NOT USE if the syringe is broken or if the liquid is clearly cloudy, has a distinctly brown color, or contains particles. In all these cases, return the complete package to the pharmacy.
6. Hold the syringe horizontally to check the expiration date printed on the label through the viewing window. Note: it is possible to rotate the inner part of the syringe so that the label can be read through the viewing window. DO NOT USE if the medication has expired. If expired, return the complete package to the pharmacy.

How to use the Xolair pre-filled syringe for injectable solution

	Carefully remove the needle cap from the syringe. Discard the cap. You may see a drop at the tip of the needle. This is normal.
	Gently pinch the skin at the injection site and insert the needle as shown in the figure. Insert the needle completely to ensure that the full dose of medication is delivered.
	Hold the syringe as shown. Slowly push the plunger all the way down until the plunger head engages the activation clips of the needle shield.
	Keep the plunger fully depressed while carefully withdrawing the needle from the injection site.
	Slowly release the plunger and allow the syringe's needle guard to automatically cover the needle. There may be a small amount of blood at the injection site. You may press the injection site with a cotton ball or gauze for 30 seconds. Do not rub the injection site. You may apply a bandage if needed.

Removal Instructions

Dispose of the used syringe in a sharps disposal container (a closed, puncture-resistant container). For safety and health reasons (for yourself and others), needles and syringes must never be reused. The disposal of unused medication and of all materials that have come into contact with it must be carried out in accordance with local regulations. Medicines should not be disposed of via drains or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.