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What Xolair is and what it is used for
The active substance of Xolair is omemalumab. Omalizumab is an artificially created protein that mimics the natural proteins produced by the body. It belongs to a class of drugs called monoclonal antibodies. It is used to prevent asthma aggravation by controlling the symptoms of severe allergic asthma in adults and children (6 years of age and older) who are already receiving asthma medications but where the symptoms of asthma are not well controlled by the medication Such as high doses of inhaled corticosteroids or inhaled beta-agonists.
Xolair works by blocking a substance called immunoglobulin E (IgE) that is formed by the body. IgE plays a key role in causing allergic asthma.
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
(Listed in section 6).
If you think you may be allergic to any of the ingredients, tell your doctor as Xolair should not be given to you.
Warnings and precautions
Xolair contains protein and proteins can cause serious allergic reactions in some people. Signs include rash, difficulty in breathing, swelling, or fainting. If you get an allergic reaction after taking Xolair, contact your doctor as soon as possible.
A certain type of allergic reaction, called serum sickness, has been observed in patients treated with Xolair. Symptoms of serum sickness may be one or more of the following: joint pain with or without edema or stiffness, rash, fever, swollen lymph nodes, muscle pain. If you get any of these symptoms and especially if you get a combination of the above symptoms, contact your doctor immediately.
Churg-Strauss syndrome and Hypereosinophilic syndrome have been observed in patients treated with Xolair. Symptoms may include one or more of the following: swelling, pain or rash during the course of lymph or blood vessels, increased white blood cell count (pronounced eosinophilia), aggravated breathing problems, nasal blockage, heart problems , Pain, numbness, tingling of the hands and feet. If you get any of these symptoms and especially if you get a combination of the above symptoms, contact your doctor immediately.
Talk to your doctor before you are given Xolair:
- If you have kidney or liver problems.
- If you have a condition where your 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 traveling to such a region because Xolair may weaken your resistance to such infections.
Xolair can not cure acute asthma symptoms such as sudden asthma attacks. Therefore, Xolair should not be used to treat such symptoms.
Xolair is not intended for the prevention or treatment of other allergic conditions such as sudden allergic reactions, hypermunoenglobin E syndrome (congenital immune disease), aspergillosis (fungal-related lung disease), food allergy, eczema or urticaria.
Children (under 6 years of age)
Xolair should not be used in children below the age of 6 years. There is insufficient data for this age group.
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 infections caused by parasites, as Xolair may reduce the effect of your medicines,
-inhiral corticosteroids and other medicines for the treatment of allergic asthma.
Pregnancy and breastfeeding
You should not be given Xolair when you are pregnant unless your doctor thinks it necessary.
If you are planning to become pregnant, tell your doctor before starting treatment with Xolair. Your doctor will discuss with you the benefits and possible risks of taking this medicinal product during pregnancy.
If you become pregnant while you are being treated with Xolair, tell your doctor immediately.
You should not be given Xolair when you are breast-feeding.
Driving and using machines
Xolair is unlikely to affect your ability to drive and use machines.
3. How Xolair is given
For instructions on the use of Xolair, see the "Information for Healthcare Professionals" section.
Xolair will be given by a doctor or nurse as an injection under the skin (subcutaneously).
Your doctor will calculate how much Xolair you need and how often you will be given. This will depend on your body weight and on the results of blood tests performed before starting treatment to determine the amount of IgE in your blood.
Observe carefully all instructions given to you by your doctor or nurse.
How much will you get?
You will be given 1 to 4 injections at a specific time, or every two weeks, or every four weeks.
Continue to take your current asthma medication while taking Xolair. Do not stop taking any asthma medication without speaking to your doctor.
You may not see immediate improvement in your asthma after starting treatment with Xolair. It usually takes between 12 and 16 weeks to get the full effect.
Use in children and adolescents
Xolair can be given to children and adolescents 6 years of age and older who are already receiving asthma treatment but whose symptoms of asthma are not well controlled by the medications administered as high doses of inhaled corticosteroids or beta-agonists. Your doctor will decide how much Xolair needs your child and how often it should be used. This will depend on the weight of the child and the blood test results taken prior to initiating treatment to determine IgE levels in his / her blood.
If you forget to take Xolair
Contact your doctor or hospital to get a new appointment as soon as possible.
If you stop taking Xolair
Do not stop taking Xolair until your doctor tells you to. Discontinuing or stopping treatment with Xolair may result in a new onset of your asthma symptoms.
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 everyone gets them. Side effects caused by Xolair are usually mild to moderate but sometimes may be serious.
Serious side effects include:
Rare side effects (may affect up to 1 in 1,000 people)
Sudden severe allergic reactions: if you notice any serious signs of allergy or a combination of signs such as rash, itching or blistering on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or
Other parts of the body, rapid heartbeat, dizziness, shortness of breath, wheezing or difficulty in breathing, or any other new symptoms, tell your doctor or nurse immediately.
Not known (frequency can not be estimated from the available data)
Development of one or more of the following symptoms: swelling, pain or rash in the blood or lymph vessels, increased number of white blood cells (pronounced eosinophilia), aggravated breathing problems, nasal blockage, heart problems, Pain, numbness, tingling in the hands and feet (signs of the so-called "Churg-Strauss syndrome or hypereosinophilic syndrome").
Low platelet counts, which are bleeding symptoms
How to store Xolair
-Due to keep out of 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 (2C - 8C). Do not freeze.
6. Package Contents and Additional Information
What Xolair contains
The active substance is omalizumab. One vial contains 75 mg omalizumab. After reconstitution, one vial contains 125 mg / ml 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 provided as a light gray powder in a small glass vial together with an ampoule containing 2 ml of water for injections. The powder dissolves in the water before being injected by a doctor or nurse.
Xolair is available in packs containing one vial of powder for solution for injection and one ampoule containing 2 ml of water for injections.
Xolair is also available in 150 mg omalizumab bottles.
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