Xolair - patient leaflet, side effects, dosage

1. What Xolair is and what it is used for

Xolair contains the active substance 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.

Xolair is used for the treatment of:

• – 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 symptoms of severe allergic asthma in adults, adolescents 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 and beta-agonist inhalers.

Chronic rhinosinusitis with nasal polyps

This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (18 years of age and older) who are already receiving intranasal corticosteroids (corticosteroid nasal spray), but whose symptoms are not well controlled by these medicines. Nasal polyps are small growths on the lining of the nose. Xolair helps to 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.

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 and chronic rhinosinusitis with nasal polyps.

2. What you need to know before you are given Xolair

You should not be given 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 be given Xolair.

Warnings and precautions

Talk to 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 are travelling to a region where infections caused by parasites are common – Xolair may

weaken your resistance to such infections.

• – if you have had a previous severe allergic reaction (anaphylaxis) for example resulting from a

medicine, an insect bite or food.

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 because Xolair has not been studied in these conditions.

Look out for signs of allergic reactions and other serious side effects

Xolair can potentially cause serious side effects. You must look out for signs of these conditions while you use Xolair. Seek medical help immediately if you notice any signs indicating a possible serious side effect. Such signs are listed under “Serious side effects” in section 4. The majority of 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. 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 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

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. 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.

Xolair may pass into breast milk. If you are breast-feeding or plan to breast-feed, ask your doctor for advice before using this medicine.

Driving and using machines

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

• 3. How Xolair is given

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).

Follow carefully all instructions given by your doctor or nurse.

How much you will be given

Your doctor will decide 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.

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

Keep taking your current asthma and/or nasal polyps medicine during Xolair treatment. Do not stop taking any asthma and/or nasal polyps medicine without talking to your doctor.

You may not see an immediate improvement after beginning Xolair therapy. In patients with nasal polyps effects have been seen 4 weeks after the start of the treatment. In asthma patients it usually takes between 12 and 16 weeks to have the full effect.

Use in children and adolescents

Allergic asthma

Xolair can be given to children and adolescents aged 6 years and older, who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high dose steroid inhalers and 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.

Chronic rhinosinusitis with nasal polyps

Xolair should not be given to children and adolescents under 18 years of age.

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 treatment with Xolair unless your doctor tells you to. Interrupting or stopping the 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 attention immediately if you notice any 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), windpipe or other parts of the body, fast heartbeat, dizziness and light-headedness, confusion, shortness of breath, wheezing or trouble breathing, blue skin or lips, collapsing and losing consciousness. If you have a history of severe allergic reactions (anaphylaxis) unrelated to Xolair you may be more at 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. 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 arms and legs.

• – Low blood 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 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 including pain, swelling, itching and redness

• – pain in the upper part of the tummy

• – headache (very common in children)

• – feeling dizzy

• – pain in joints (arthralgia)

Uncommon (may affect up to 1 in 100 people)

• – feeling 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 (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, 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 via the national reporting system listed in 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. The expiry date refers

to the last day of that month.

• – Store in a refrigerator (2°C – 8°C). Do not freeze.

6. Contents of the pack 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 ingredients are sucrose, L-histidine, L-histidine hydrochloride monohydrate and

polysorbate 20.

What Xolair looks like 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 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 vial of powder for solution for injection and one ampoule of 2 ml water for injections.

Xolair is also available in vials with 150 mg omalizumab.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

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

België/Belgiqu­e/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11	Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Efc^rapufl Novartis Bulgaria EOOD Ten.: +359 2 489 98 28	Luxembourg/Lu­xemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Česká republika Novartis s.r.o. Tel: +420 225 775 111	Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00
Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0	Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810	Norge Novartis Norge AS Tlf: +47 23 05 20 00
EÀÀàôa Novartis (Hellas) A.E.B.E. Tql: +30 210 281 17 12	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
España Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Polska 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
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	România Novartis Pharma Services Romania SRL 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	Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200

Kûnpoç

Novartis Pharma Services Inc.

Tql: +357 22 690 690

United Kingdom (Northern Ireland)

Novartis Ireland Limited

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for 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 to slightly opalescent, colourless to pale brownish-yellow 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 0.6 ml.

To prepare Xolair 75 mg vials for subcutaneous administration, please adhere to the following instructions:

• 1. Draw 0.9 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 to slightly opalescent, colourless to pale brownish-yellow. 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 0.6 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 0.6 ml (75 mg) of Xolair.

• 8. The injections are administered subcutaneously in the deltoid region of the arm, the lower abdomen (but not the area 5 centimetres around the navel) or the thigh.