Xolair 150 mg powder and solvent for solution for injection

The active substance of Xolair is omalizumab. Omalizumab is a man-made protein that is similar to natural proteins produced by the body; it belongs to a class of medicines called monoclonal antibodies.It is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in adults and children (6 years of age and older) who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers or beta-agonist inhalers.

Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body. IgE plays a key role in causing allergic asthma.

You should not be given Xolair

• if you are allergic (hypersensitive) to omalizumab or any of the other ingredients of Xolair. The ingredients are listed in section 6 of this leaflet. If you think you may be allergic to any of the ingredients, tell your doctor since you should not be given Xolair.

Take special care with Xolair

Xolair contains a protein, and proteins can cause serious allergic reactions in some people. Signs include rash, difficulty in breathing, swelling or feeling faint. If you have an allergic reaction after taking Xolair, contact a doctor as soon as you can.

A certain type of allergic reaction called serum sickness has been observed in patients treated with Xolair. The symptoms of serum sickness can be one or more of the following symptoms: joint pain with or without swelling or stiffness, rash, fever, swollen lymph nodes, muscle pain. If you experience any of these symptoms, or in particular if you experience a combination of such symptoms, contact your doctor immediately.

Churg-Strauss and Hypereosinophilic syndrome have been observed in patients treated with Xolair. The symptoms may include one or more of the following: swelling, pain or rash around blood or lymph vessels, high level of a specific type of white blood cells (marked eosinophilia), worsening problems with breathing, nasal congestion, heart problems, pain, numbness, tingling in the arm and legs. If you experience any of these symptoms, or in particular if you experience a combination of such symptoms, contact your doctor immediately.

Tell your doctor before you are given Xolair:

• if you have kidney or liver problems.
• if you have a disorder where your own immune system attacks parts of your own body (autoimmune disease).
• if you live in a region where infections caused by parasites are common or if you are travelling to such a region as Xolair may weaken your resistance to such infections.

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

Xolair is not meant to prevent or treat other allergy-type conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungus-related lung disease), food allergy, eczema or hay fever.

Children (under 6 years of age)

Xolair should not be given to children under 6 years of age. There are not enough data in this group.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is especially important if you are taking:

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

Pregnancy and breast-feeding

You should not take Xolair when you are pregnant, unless this is considered necessary by your doctor.

If you plan to become pregnant, tell your doctor before starting treatment with Xolair. Your doctor will discuss with you the benefits and potential risks of being given this medicine during pregnancy.

If you become pregnant while being treated with Xolair, tell your doctor immediately.

You should not take Xolair when you are breast-feeding.

Driving and using machines

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

Instructions on how to use Xolair are given in the section ?Information for the healthcare professional?.

Xolair is given to you by a doctor or nurse as an injection just under the skin (subcutaneously).

Your doctor will work out how much Xolair you need and how often you will be given it. This depends on your body weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in your blood.

Follow carefully all instructions given by your doctor or nurse.

How much you will be given

You will be given 1 to 4 injections at a time, either every two weeks, or every four weeks.

Carry on taking your current asthma medicine during Xolair treatment. Do not stop taking any asthma medicines without talking to your doctor.

You may not see an immediate improvement in your asthma after beginning Xolair therapy. It usually takes between 12 and 16 weeks to have the full effect.

Use in children

Xolair can be given to children and adolescents aged 6 years or older, who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high dose steroid inhalers or beta-agonist inhalers. Your doctor will work out how much Xolair your child needs and how often it needs to be given. This will depend on your child-s weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in his/her blood.

If a dose of Xolair is missed
Contact your doctor or hospital as soon as possible to re-schedule your appointment.

If you stop treatment with Xolair

Do not stop taking Xolair unless your doctor tells you to. Interrupting or stopping the treatment with Xolair may cause your asthma symptoms to come back.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, Xolair 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.

The frequency of possible side effects listed below is defined using the following convention:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data.

Serious side effects include:
Rare side effects
- Sudden severe allergic reactions: if you notice any serious sudden signs of allergy or combination of signs such as rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (voice box), windpipe or other parts of the body, fast heart beat, dizziness and light-headedness, shortness of breath, wheezing or trouble breathing, or any other new symptoms, tell your doctor or nurse immediately.
Not known
- Development of one or more of the following symptoms: swelling, pain or rash around blood or lymph vessels, high level of a specific type of white blood cells (marked eosinophilia), worsening problems with breathing, nasal congestion, heart problems, pain, numbness, tingling in the arms and legs (signs of so-called ?Churg-Strauss syndrome or hypereosinophilic syndrome?).
- Low blood platelet count with symptoms such as bleeding or bruising more easily than normal.

- Development of any of the following symptoms, especially if in combination: joint pain with or without swelling or stiffness, rash, fever, swollen lymph nodes, muscle pain (signs of serum sickness).
If you experience any of these, tell your doctor or nurse straight away.

Other side effects include:

Very common side effects
- fever (in children)

Common side effects
- reactions at the injection site including pain, swelling, itching and redness
- pain in the upper part of the tummy (in children)
- headache (very common in children)

Uncommon side effects feeling dizzy, sleepy or tired tingling or numbness of the hands or feet fainting, low blood pressure while sitting or standing postural hypotension, flushing sore throat, coughing, acute breathing problems feeling sick nausea, diarrhoea, indigestion itching, hives, rash, increased sensitivity of the skin to sun weight increase flu-like symptoms swelling arms

Rare side effects
- parasitic infection

Not known
- joint pain, muscle pain and joint swelling
- hair loss

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

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, histidine hydrochloride monohydrate and polysorbate 20.

What Xolair looks like and contents of the pack

Xolair 150 mg powder and solvent for solution for injection is supplied as an off-white powder in a small glass vial together with an ampoule containing 2 ml of water for injections. The powder is reconstituted in the water before it is injected by a doctor or nurse.

Xolair is available in packs containing one, four or ten vials of powder for solution for injection and one, four or ten ampoules of 2 ml water for injections. Not all pack sizes may be marketed.

Xolair is also available in vials with 75 mg omalizumab.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma S.A.S.
Centre de Biotechnologie
8, rue de l-Industrie
F-68330 Huningue
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

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

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

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

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

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only:

The lyophilised medicinal product takes 15-20 minutes to dissolve, although in some cases it may take longer. The fully reconstituted medicinal product will appear clear or slightly opaque and may have a few small bubbles or foam around the edge of the vial. Because of the viscosity of the reconstituted medicinal product care must be taken to withdraw all of the medicinal product from the vial before expelling any air or excess solution from the syringe in order to obtain the 1.2 ml.

To prepare Xolair 150 mg vials for subcutaneous administration, please adhere to the following instructions:

1. Draw1.4 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.

2. With the vial placed upright on a flat surface, insert the needle and transfer the water for injections into the vial containing the lyophilised powder using standard aseptic techniques, directing the water for injections directly onto the powder.

3. Keeping the vial in an upright position, vigorously swirl it (do not shake) for approximately 1 minute to evenly wet the powder.

4. To aid in dissolution after completing step 3, gently swirl the vial for 5-10 seconds approximately every 5 minutes in order to dissolve any remaining solids.

Note that in some cases it may take longer than 20 minutes for the powder to dissolve completely. If this is the case, repeat step 4 until there are no visible gel-like particles in the solution.

When the medicinal product is fully dissolved, there should be no visible gel-like particles in the solution. Small bubbles or foam around the edge of the vial are common. The reconstituted medicinal product will appear clear or slightly opaque. Do not use if solid particles are present.

5. Invert the vial for at least 15 seconds in order to allow the solution to drain towards the stopper. Using a new 3-ml syringe equipped with a large-bore, 18-gauge needle, insert the needle into the inverted vial. Keeping the vial inverted position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.

6. Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.

7. Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 ml dose. A thin layer of small bubbles may remain at the top of the solution in the syringe. Because the solution is slightly viscous, it may take 5-10 seconds to administer the solution by subcutaneous injection.

The vial delivers 1.2 ml (150 mg) of Xolair. For a 75 mg dose, draw up 0.6 ml into the syringe and discard the remaining solution.

8. The injections are administered subcutaneously in the deltoid region of the arm or the thigh.