Xolair 150 mg powder and solvent for solution for injection - United Kingdom[英国药品]

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Xolair 150 mg powder and solvent for solution for injection

2014-11-07 00:08:51 来源: 作者: 【大中小】浏览:378次评论:0条

For doctors

What is it and how is it used?

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.

What do you have to consider before using it?

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:

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:

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.

How is it used?

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.

What are 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.

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.

How should it be stored?

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For doctors

What is it?

Xolair is a medicine that contains the active substance omalizumab. It is available in two forms: as a vial containing a powder and solvent that are made up into a solution for injection; and as a prefilled syringe containing a solution for injection. Each vial and syringe contains 75 or 150 mg of omalizumab.

What is it used for?

Xolair is used to improve the control of severe persistent asthma that is caused by an allergy. It is used as an add-on to existing asthma treatment in patients aged six years or over.

All patients receiving Xolair must meet the following criteria:

they must have had a positive skin test result for an allergy caused by an allergen a stimulus that causes an allergy in the air, such as house dust mites, pollen or mould

they must have frequent symptoms during the day or waking up during the night

they must have had many severe exacerbations of asthma where asthma gets worse, requiring rescue treatment with other medicines despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist.

Patients aged 12 years or over must also have reduced lung function (less than 80% of normal).

For patients of all ages, Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE).

The medicine can only be obtained with a prescription.

How is it used?

Xolair treatment should be started by a doctor who has experience in the treatment of severe persistent asthma.

Before giving Xolair, the doctor must measure the level of IgE in the patient’s blood. Patients with low IgE levels are less likely to benefit from the medicine. Xolair is given by a healthcare professional as an injection under the skin of the shoulder or the thigh every two or four weeks. The dose of Xolair and how often it is given depend on the level of IgE in the blood and body weight. The usual dose range is between 75 and 600 mg in one to four injections, and the maximum recommended dose is 600 mg every two weeks.

Xolair is intended for long-term use. It usually takes 12 to 16 weeks for Xolair to show a benefit. See the summary of product characteristics (also part of the EPAR) for further information.

How does it work?

The active substance in Xolair, omalizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Omalizumab has been designed to attach to human IgE, which is produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen. By attaching to IgE, omalizumab ‘mops up’ the free IgE circulating in the blood. This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction. This helps to reduce the symptoms of allergy, such as asthma attacks.

How has it been studied?

Xolair has been studied in over 2,000 patients aged 12 years or over with allergic asthma in five main studies, including one study involving 482 patients with severe allergic asthma that was not controlled by conventional treatments. It has also been studied in 627 children aged between six and 12 years.

In all of the studies, Xolair was compared with placebo (a dummy treatment), when they were added to the patients’ existing treatment. The main measures of effectiveness were the number of exacerbations, the number of patients who had an exacerbation, quality of life (assessed using standard questionnaires), and the amount of inhaled corticosteroid that the patients needed to take to treat their asthma.

What benefits has it shown during the studies?

In patients aged 12 years or over, Xolair reduced the number of exacerbations by around half. Over the first 28 or 52 weeks of treatment in the first three studies, there were around 0.5 exacerbations per year in the Xolair group and around one per year in the placebo group. In addition, fewer of the patients receiving Xolair had exacerbations than those receiving placebo. They also reported a greater improvement in quality of life and used less fluticasone (a corticosteroid). The effects of Xolair were greater in patients with severe asthma.

In the study of patients with severe allergic asthma, there was no difference in the number of asthma exacerbations between Xolair and placebo, but Xolair led to a similar reduction in the number of exacerbations as in previous studies.

In the study in children aged between six and 12 years, the number of exacerbations was lower in those receiving Xolair. Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there was an average of 0.4 exacerbations over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo.

What is the risk associated?

In patients aged 12 years and over, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache and injection site reactions, including swelling, redness, pain and itching. In children aged between six and 12 years, the most common side effects (seen in more than 1 patient in 10) are headache and pyrexia (fever). For the full list of all side effects reported with Xolair, see the package leaflet.

Xolair should not be used in people who may be hypersensitive (allergic) to omalizumab or any of the other ingredients.

Why has it been approved?

The CHMP concluded that, overall, there was a pattern of results in the studies of Xolair that show that it is effective in treating severe allergic asthma. Therefore, the Committee decided that Xolair’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Xolair to Novartis Europharm Limited on 25 October 2005. After five years, the marketing authorisation was renewed for a further five years.

For more information about treatment with Xolair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2010.

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