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Xolair 150 mg powder and solvent for solution for injection

Xolair 150 mg powder and solvent for solution for injection

Omalizumab

Read all of this leaflet carefully before you start using Xolair.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • 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.

In this leaflet:

  • 1. What Xolair is and what it is used for
  • 2. Before you are given Xolair
  • 3. How Xolair is given
  • 4. Possible side effects
  • 5. How to store Xolair
  • 6. Further information

What Xolair Is And What It Is Used For

Xolair is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in patients (6 years of age and older) who are already receiving asthma medication, 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.

Before You Are Given Xolair

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

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 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.

Xolair does not treat acute asthma symptoms, such as a sudden asthma attack.

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, allergic skin rash or hay fever.

Children (under 6 years of age)

Do not give Xolair 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.

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

Xolair may make you feel dizzy, sleepy or faint. If this happens to you, do not drive or use machines.

Important information about some of the ingredients of Xolair

If you are a diabetic or have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Xolair. Xolair contains sucrose.

How Xolair Is Given

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

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 several weeks to have the full effect.

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

Interrupting or stopping the treatment with Xolair may cause your asthma symptoms to come back.

Possible Side Effects

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.

Very common side effects (affects 10 or more users in 100)

Common side effects (affects 1 to 10 users in 100)

Uncommon side effects (affects 1 to 10 users in 1,000)

Rare side effects (affects 1 to 10 users 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 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 any combination of the following symptoms: pain, numbness, tingling in the arms and legs, lumps or raised patches in the skin, worsening problems with breathing, nasal congestion (signs of so-called “Churg-Strauss 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, 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 abdomen (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, joint pain, muscle pain and joint swelling
  • hair loss

Rare side effects

  • parasitic infection

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.

How To Store Xolair

  • Keep out of the reach and sight of children.
  • Do not use after the expiry date which is stated on the label.
  • Store in the original package.
  • Store in a refrigerator (2°C - 8°C). Do not freeze.

Further Information

What Xolair contains

  • The active substance is omalizumab.
  • The other ingredients are sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
  • An ampoule containing 2 ml of water for injections, which is used to dissolve the powder before injection, is also provided in the pack.

What Xolair looks like and contents of the pack

Xolair 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 health professional. Each vial delivers 150 mg of omalizumab.

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.

United Kingdom
Novartis Pharmaceuticals UK Ltd.
Tel: +44 1276 698370

This leaflet was last approved in January 2010





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