Xolair 75 mg solution for injection

Package leaflet: Information for the user

Introduction

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 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the 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 human 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 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 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 sense of smell, postnasal drip, and runny nose.

Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body. IgE is involved in 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 components, 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 parts of your own body (autoimmune disease),
• if you are traveling 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 acute asthma symptoms, such as a sudden asthma attack. Therefore, Xolair should not be used to treat these types of symptoms.

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 immediate medical help if you notice any signs indicating a severe allergic reaction or other serious adverse effects. These signs are described under "Serious adverse effects" in section 4.

Before you or someone other than a healthcare professional administers Xolair, it is important that you receive training from your doctor on how to recognize early symptoms of severe allergic reactions and what to do 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.

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 are planning to become pregnant, consult 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, consult your doctor before using this medicine.

Driving and using machines

Xolair is unlikely to affect your ability to drive or operate machinery.

3. How to use Xolair

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

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 will self-inject Xolair. The first three doses will always be 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 before self-administering it.
• A caregiver (e.g., 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 the pre-filled 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 on the early signs and symptoms of severe allergic reactions, see section 4.

How much to use

Your doctor will decide 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 level of IgE in your blood.

You will need between 1 and 4 injections at the same time. You will need 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 experience 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.

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 of 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-administer Xolair. However, if considered appropriate by the doctor, a caregiver may administer the injection 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 forget a dose of Xolair

If you have missed 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.

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 severe.

Serious adverse effects:

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

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

• Severe allergic reactions (including anaphylaxis). Symptoms may include rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (voice box), trachea or other parts of the body, rapid heartbeat, dizziness and a slight feeling of faintness, confusion, shortness of breath, wheezing or difficulty breathing, blue-colored skin or lips, collapse and loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Xolair, you may be at 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 cells (marked eosinophilia), worsening respiratory problems, nasal congestion, heart problems, pain, numbness, or tingling in arms and legs.
• Low platelet count, with symptoms such as bleeding or bruising occurring more easily than normal.
• Serum sickness. Symptoms may include one or more of the following: joint pain with or without inflammation 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)
• dizziness
• joint pain (arthralgia)

Uncommon (may affect up to 1 in 100 patients)

• feeling sleepy or tired
• tingling or numbness in hands or feet
• fainting, drop in blood pressure when sitting or standing up (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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after CAD/EXP. The expiry date refers to the last day of the month indicated. The pack 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 0.5 ml syringe of solution contains 75 mg of omalizumab.
• The other components are arginine hydrochloride, monohydrate histidine hydrochloride, histidine, polysorbate 20, and water for injections.
• The needle cap of the syringe may contain dry rubber (latex).

Nature of the product and pack contents

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

Xolair 75 mg solution for injection in a pre-filled syringe with a fixed 26-gauge needle and blue syringe cap is available in packs containing 1 pre-filled syringe and in multiple packs containing 4 (4 × 1) or 10 (10 × 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 Nürnberg
Germany

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: 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, their caregiver may administer Xolair after receiving proper training. The pack contains the pre-filled syringe(s) of Xolair individually sealed in a plastic tray.

Your Xolair 75 mg pre-filled syringe for injection

Once the medicine has been injected, the syringe shield 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:

Important safety information

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

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

Storage of Xolair pre-filled syringe for injection solution

• Store this sealed medicine in its carton to protect from light. Store in a refrigerator between 2°C and 8°C. DO NOT FREEZE.
• Remember to remove the syringe from the refrigerator so it can reach room temperature (25°C) before preparing the injection (this will take approximately 30 minutes). Leave the syringe in its 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

Preparation of Xolair Injectable Solution in a Ready-to-Use Prefilled Syringe

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. Clean the injection site thoroughly 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 range from colorless to pale yellowish-brown. Small air bubbles may be present, which is 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: the inner part of the syringe may be rotated so that the label can be read through the viewing window. DO NOT USE if the medicine has expired. If expired, return the complete package to the pharmacy.

How to use the Xolair prefilled syringe for injectable solution

Disposal instructions