XOLAIR 75 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Xolair 75mg solution for injection in pre-filled syringe

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

omalizumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Xolair and what is it used for
2. What you need to know before you use Xolair
3. How to use Xolair
4. Possible side effects
5. Storing Xolair
6. Package contents and further information

1. What is Xolair and what is it 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

Allergic asthma

This medicine is used to prevent asthma from getting worse by controlling the symptoms of severe allergic asthma in adults, adolescents, and children (from 6 years of age) who are already taking asthma medicines, but whose symptoms are not adequately controlled with 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 taking intranasal corticosteroids (nasal spray with corticosteroids), but whose symptoms are not well controlled with these medicines. Nasal polyps are small growths in the lining of the nose. Xolair helps to reduce the size of the polyps and improve symptoms including nasal congestion, loss of sense of smell, mucus in the back of the throat, and nasal discharge.

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 you use Xolair

Do not use Xolair

• if you are allergic to omalizumab or 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 should not use Xolair.

Warnings and precautions

Tell your doctor before using Xolair:

• if you have kidney or liver problems,
• if you have a condition where your immune system attacks parts of your body (autoimmune disease),
• if you are going to travel to a region where parasitic infections are common, as Xolair may reduce your resistance to these infections,
• if you have had a severe allergic reaction (anaphylaxis) in the past, for example, as a result of taking a medicine, an insect sting, or food,
• if you have had an allergic reaction to latex. The needle cap of the pre-filled syringe may contain dry natural rubber (latex).

Xolair does not treat acute asthma symptoms, 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 conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (inherited immune disorder), aspergillosis (lung disease caused by a fungus), food allergy, eczema, or hay fever, as Xolair has not been studied in these conditions.

Monitor for signs of allergic reactions and other serious side effects

Xolair may cause serious side effects. You should monitor for signs of these effects while using Xolair. Seek medical help immediately if you notice any signs that indicate a severe allergic reaction or other serious side effects. These signs are mentioned in "Serious side effects" in section 4.

Before you or someone else injects Xolair, it is essential that you receive training from your doctor on how to recognize the early symptoms of severe allergic reactions and how to act 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 in children under 6 years of age has not been studied.

Chronic rhinosinusitis with nasal polyps

Xolair is not recommended for children and adolescents under 18 years of age. Its use in patients under 18 years of age 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 using:

• medicines to treat a parasitic infection, as Xolair may reduce the effect of your 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 have a baby, ask your doctor for advice before taking 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, ask your doctor for advice before taking this medicine.

Driving and using machines

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

3. How to use Xolair

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask your doctor, pharmacist, or nurse again.

How to use Xolair

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

Xolair injection

• You and your doctor will decide if you will inject Xolair yourself. The first three doses will always be injected under the supervision of a healthcare professional (see section 2).
• It is essential that you have received proper training on how to inject the medicine before you do it yourself.
• The caregiver (e.g., parents) can give the Xolair injection after proper training.

For detailed instructions on how to inject Xolair, see "Instructions for use of Xolair in pre-filled syringe" at the end of this leaflet.

Training to recognize severe allergic reactions

It is also essential that you do not inject Xolair yourself until your doctor or nurse has taught you:

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

For more information on the signs and symptoms of severe allergic reactions, see section 4.

How much to use

Your doctor will decide how much Xolair you need and how often you should use it. This depends on your body weight and the results of a blood test done 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 2 or 4 weeks.

Continue taking your current asthma and/or nasal polyp medication while you are being treated with Xolair. Do not stop any asthma and/or nasal polyp medication without talking to your doctor.

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

Use in children and adolescents

Allergic asthma

Xolair can be used in children and adolescents from 6 years of age who are already taking asthma medication, but whose asthma symptoms are not well controlled by medicines such as high-dose inhaled corticosteroids and inhaled beta-agonists. Your doctor will tell you how much Xolair your child needs and how often it should be given. This will depend on the child's weight and the results of blood tests done before starting treatment to determine the level of IgE in their blood.

Children (from 6 to 11 years of age) are not expected to inject Xolair themselves. However, if the doctor considers it appropriate, the caregiver can give the injection after proper training.

Chronic rhinosinusitis with nasal polyps

Xolair should not be used in children and adolescents under 18 years of age.

If you miss a dose of Xolair

If you miss a visit, contact your doctor or hospital as soon as possible to reschedule.

If you forget to inject a dose of Xolair, inject it as soon as you remember. Then, talk to your doctor to find out when you should have your next dose.

If you stop using Xolair

Do not stop using Xolair unless your doctor tells you to. Stopping or ending treatment with Xolair may cause your symptoms to come back.

If you have any further questions on 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 to moderate but can occasionally be serious.

Serious side effects:

Seek medical help immediately if you notice any of the signs of the following side effects:

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 (voice box), trachea, or other parts of the body, fast heartbeat, dizziness, and lightheadedness, confusion, shortness of breath, wheezing, or difficulty breathing, blue-tinged 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 greater risk of developing a severe allergic reaction after using Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, pain and swelling of the joints, rash, fever, weight loss, and fatigue.

Frequency not known (cannot be estimated from the 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 lymph nodes, high 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 blood platelet count with symptoms such as bleeding or bruising that occurs 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, swelling of the 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 including pain, swelling, itching, and redness
• upper stomach pain
• 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 of hands or feet
• fainting, low blood pressure when sitting or standing up (postural hypotension), flushing
• sore throat, cough, acute respiratory problems
• feeling sick (nausea), diarrhea, indigestion
• itching, hives, rash, increased sensitivity of the skin to the sun
• weight gain
• flu-like symptoms
• swollen arms

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

• parasitic infection

Frequency not known (cannot be estimated from the available data)

• muscle pain and joint inflammation
• hair loss

Reporting of side effects

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

5. Storing 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 is the last day of the month shown. The pre-filled syringe can be stored for a total of 48 hours at room temperature (25°C) before use.
• Store in the original package to protect from light.
• Store in a refrigerator (between 2°C and 8°C). Do not freeze.
• Do not use any packaging that is damaged or shows signs of deterioration.

6. Package Contents and Additional Information

Xolair Composition

• The active ingredient is omalizumab. A 0.5 ml solution syringe contains 75 mg of omalizumab.
• The other components are arginine hydrochloride, histidine monohydrochloride monohydrate, histidine, polysorbate 20, and water for injectable preparations.
• The needle shield of the syringe may contain dry rubber (latex).

Product Appearance and Package Contents

Xolair injectable solution is presented as a clear to slightly opalescent, colorless to pale yellowish-brown solution, in a pre-filled syringe.

Xolair 75 mg injectable solution in a pre-filled syringe with a fixed 26-gauge needle and a blue syringe shield is available in packs containing 1 pre-filled syringe and in multipacks containing 4 (4 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 Nürnberg

Germany

You can request more information about this medicinal product from the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:

Other Sources of Information

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

XOLAIR PRE-FILLED SYRINGE INSTRUCTIONS FOR USE

Read ALL the instructions before injecting the medicine. If your doctor decides that you or the person caring for you can administer your Xolair injections at home, you will need to receive training from your doctor, nurse, or pharmacist before you inject the medicine or inject it into others. It is not expected that children (from 6 years to less than 12 years of age) will self-inject Xolair; however, if your doctor considers it appropriate, their caregiver may inject Xolair after receiving proper training. The box contains the Xolair pre-filled syringe(s) individually closed in a plastic tray.

Your Xolair 75 mg Solution for Injection Pre-filled Syringe

Once the medicine has been injected, the syringe shield will activate to cover the needle. This is designed to protect against accidental needlestick injuries.

What you will need for the injection:

Important Safety Information

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

• The needle cap of the syringe may contain dry rubber (latex) that should not be touched by people sensitive to this substance.
• Do not open the sealed box until you are ready to use this medicine.
• Do not use this medicine if the box seal or 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 has been dropped after removing the needle cap.
• Never leave the syringe in places where others may touch it.
• Do not shake the syringe.
• Be very careful not to touch the activation clips before use. If you do, the needle shield will activate too early.
• Do not remove the needle cap until just before injecting.
• The syringe cannot be reused. Once used, dispose of the syringe in a sharps container.

Storage of Xolair Solution for Injection Pre-filled Syringe

• Store this medicine sealed in its box 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 to allow it to reach room temperature (25°C) before preparing the injection (this will take approximately 30 minutes). Leave the syringe in the box to protect it from light. The total time the syringe can remain at room temperature (25°C) before use should not exceed 48 hours.
• Do not use the syringe after the expiry date shown on the box or on the syringe label. If it has expired, return the complete package to the pharmacy.

Injection Site

Preparing Xolair Solution for Injection Pre-filled Syringe for Use

1. Remove the box with the syringe from the refrigerator and leave it unopenedfor approximately 30 minutes, until it reaches room temperature (leave the syringe inside the box to protect it from light).
2. When you are ready to use the syringe, wash your hands well with soap and water.
3. Disinfect the injection site well with an alcohol wipe.
4. Remove the plastic tray from the box and remove the paper covering it. Hold the syringe by the middle of its blue shield and pull the syringe out of the tray.
5. Inspect the syringe. The liquid should be clear to slightly turbid. Its color may vary from colorless to pale yellowish-brown. There may be a small air bubble, which is normal. DO NOT USE if the syringe is broken or if the liquid is clearly turbid, has a clearly brown color, or contains particles. In all these cases, return the complete package to the pharmacy.
6. Hold the syringe horizontally to check the expiry date printed on the label through the viewer. Note: You can rotate the inner part of the syringe so that the label can be read through the viewer window. DO NOT USE if the medicine has expired. If it has expired, return the complete package to the pharmacy.

Using the Xolair Solution for Injection Pre-filled Syringe

Disposal Instructions