75 mg solution for injection in a pre-filled syringe
omalizumab
What Xolair is and what it is used for
Xolair contains the active substance omalizumab, an artificial protein that is similar to the natural proteins produced in the body. Omalizumab belongs to a group of medicines called monoclonal antibodies.
Xolair is used to treat:
- Allergic asthma
- Chronic inflammation of the nose and sinuses ( rhinosinusitis ) with nasal polyps
Allergic asthma
This medicine is used to prevent the worsening of asthma by controlling the symptoms of severe allergic asthma in adults, adolescents, and children (aged 6 and over) who are already taking other asthma medicines, but whose asthma symptoms are not well controlled despite medicines such as high- dose inhaled steroids and beta stimulators for inhalation.
Chronic inflammation of the nose and sinuses with nasal polyps
This medicine is used to treat chronic inflammation of the nose and sinuses with nasal polyps in adults (from the age of 18) who are already using a corticosteroid that is taken into the nose (cortisone nasal spray), but whose symptoms are not well-controlled. Nasal polyps are small growths on the mucous membrane of the nose. Xolair helps reduce the size of the polyps and improves symptoms such as nasal congestion, impaired sense of smell, mucus in the back of the throat, and runny nose.
Xolair works by blocking a substance called IgE (short for immunoglobulin E), which is produced in the body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and chronic inflammation of the nose and sinuses with nasal polyps.
What you need to know before you use Xolair
Do not use 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 use Xolair.
Warnings and precautions
Talk to your doctor before using Xolair:
- if you have kidney or liver problems
- if you have a disease where your immune system attacks parts of the body ( autoimmune disease)
- if you travel to an area where infections caused by parasites are common – Xolair may weaken your resistance to such infections
- if you have previously had a severe allergic reaction ( anaphylactic reaction ), e.g. as a result of medicines, insect bites, or food
- if you have ever had an allergic reaction to latex – the needle guard on the syringe may contain dry rubber (latex).
Xolair should not be used to treat acute asthma symptoms, eg a sudden asthma attack.
Xolair is not intended to prevent or treat other allergic conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a lung disease caused by mold), food allergy, eczema, or hay fever because Xolair has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious side effects
Xolair can cause serious side effects. You need to look out for signs of these when using Xolair. Seek immediate medical attention if you notice any signs of a severe allergic reaction or another serious side effect. Such signs are listed under “Serious side effects” in section 4.
Before you or a family member injects Xolair, you must be trained in how to recognize the early symptoms of serious allergic reactions and how to deal with them if they occur (see section 3 “How to use Xolair”). The majority of serious allergic reactions occur with the first 3 doses of Xolair.
Children and young people
Allergic asthma
Xolair is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic inflammation of the nose and sinuses with nasal polyps
Xolair is not recommended for children and adolescents under 18 years of age. Use in patients under 18 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:
- medicine to treat a parasitic infection, as Xolair can reduce the effect of the medicine
- inhaled steroids and other medicines for allergic asthma.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. The doctor will discuss the benefits and possible risks of using this medicine during pregnancy with you.
If you become pregnant while being treated with Xolair, tell your doctor immediately.
Xolair can pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine.
Driving ability and use of machinery
Xolair is unlikely to affect your ability to drive or use machines.
How to use Xolair
Always use this medicine as directed by your doctor. Consult a doctor, nurse, or pharmacist if you are unsure.
How Xolair is given
Xolair should be given as an injection under the skin (so-called subcutaneous injection ).
Injection of Xolair
- You and your doctor will decide whether you should inject Xolair yourself. The first 3 doses should always be given by, or under the supervision of, healthcare professionals (see section 2).
- Before you inject yourself, you must receive proper training in how to inject the medicine.
- A relative (for example, a parent) can also give Xolair injections after they have been properly trained.
For detailed instructions on how to inject Xolair, see “Instructions for using the Xolair pre-filled syringe” at the end of this leaflet.
Education to recognize severe allergic reactions
You mustn’t inject Xolair yourself until you have been trained by your doctor or nurse to:
- how to recognize early signs and symptoms of serious allergic reactions
- what to do if symptoms occur.
For more information on the early signs and symptoms of serious allergic reactions, see section 4.
What dose to use
Your doctor will decide how much Xolair you need and how often you will be treated. It is based on your body weight and the amount of IgE in your blood. A blood sample to measure the amount of IgE is taken before treatment begins.
You will need 1 to 4 injections each time, either every two or four weeks.
Continue to take your usual asthma medication and/or nasal polyp medication during treatment with Xolair. Do not stop taking any of your asthma and/or nasal polyp medications without talking to your doctor.
You may not see any improvement immediately after starting treatment with Xolair. In patients with nasal polyps, an effect has been seen 4 weeks after starting treatment. In asthma patients, it generally takes 12 to 16 weeks for the treatment to be fully effective.
Use for children and adolescents
Allergic asthma
Xolair can be used by children and adolescents who are 6 years of age and older and who are already taking other asthma medications, but whose asthma symptoms are not well controlled despite medications such as high-dose inhaled steroids and inhaled beta-stimulators. The doctor calculates how much Xolair the child needs and how often it needs to be given. This is calculated based on the child’s body weight and the results of the blood samples taken before the start of treatment to measure the amount of IgE in the blood.
Children (6 to 11 years) are not expected to self-administer Xolair. If the doctor considers it appropriate, for example, a guardian can administer Xolair after training.
Chronic inflammation of the nose and sinuses with nasal polyps
Xolair should not be given to children and adolescents under the age of 18.
If you forget a dose of Xolair
If you have missed an appointment for a Xolair injection, contact the doctor or hospital as soon as possible to make a new appointment.
If you forget to use a dose of Xolair yourself, inject dose one as soon as you remember. Then talk to your doctor about when to take the next dose.
If you stop using Xolair
Do not stop Xolair treatment unless your doctor tells you to. After stopping or stopping treatment with Xolair, your symptoms may return.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Xolair are generally mild to moderate but can be serious in some cases.
Serious side effects:
Seek immediate medical attention if you notice any signs of the following side effects:
Rare (may affect up to 1 in 1,000 people)
- Severe allergic reactions (including anaphylactic reactions). Symptoms may include skin rash, itching or hives, swelling of the face, lips, tongue, throat or trachea, or other parts of the body, fast heartbeat, dizziness and feeling drunk, confusion, shortness of breath, wheezing or difficulty breathing, bluish skin or lips, drop in blood pressure with fainting or loss of consciousness. If you have had severe allergic reactions (anaphylactic reactions) in the past that were not due to Xolair, the risk of a severe allergic reaction may be greater when using Xolair.
- Systemic lupus erythematosus ( SLE ). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.
No known frequency (frequency cannot be calculated from available data)
- Churg-Strauss or hypereosinophilic syndrome. Symptoms may include one or more of the following: swelling, pain, or rash around blood or lymph vessels, increased levels of a certain type of white blood cell (pronounced eosinophilia ), worsening breathing problems, nasal congestion, heart problems, aches, numbness, tingling in the arms or legs.
- Low thrombocyte levels ( platelets ), can cause symptoms such as bleeding or bruising more easily than usual.
- Serum sickness. Symptoms may include one or more of the following: joint pain with or without swelling or stiffness, skin rash, fever, swollen lymph nodes, and muscle pain.
Other side effects are:
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, such as pain, swelling, itching, and redness
- pain in the upper part of the stomach
- headache (very common in children)
- dizziness
- joint pain ( arthralgia )
Uncommon (may affect up to 1 in 100 people)
- feeling sleepy or tired
- tingling or numbness in the hands or feet
- fainting, low blood pressure when sitting or standing up ( postural hypotension ), flushing
- sore throat, cough, acute respiratory problems
- feeling sick (nausea), diarrhea, indigestion
- itching, hives, skin rash, increased photosensitivity
- weight gain
- flu-like symptoms
- swollen arms.
Rare (may affect up to 1 in 1,000 people)
- parasitic infection.
No known frequency (frequency cannot be calculated from available data)
- muscle pain and swollen joints
- hair loss.
How to store Xolair
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the label. The expiration date is the last day of the specified month.
- Store in the original packaging. Light sensitive.
- Store in a refrigerator (2ºC- 8ºC). Do not freeze.
- Do not use a package that is damaged or shows signs of tampering.
Contents of the packaging and other information
Contents declaration
- The active substance is omalizumab. One syringe of 0.5 ml solution for injection contains 75 mg omalizumab.
- Other ingredients are L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, and water for injections.
- The needle guard on the syringe may contain dry rubber (latex).
Appearance and package sizes of the medicine
Xolair solution for injection is supplied as a clear to slightly opalescent, colorless to slightly brown-yellow solution in a pre-filled syringe.
Xolair 75 mg solution for injection is supplied in packs containing 1 pre-filled syringe and in multipacks containing 4 (4 x 1) or 10 (10 x 1) pre-filled syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
D‑90429 Nuremberg
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienNovartis Pharma NVTél/Tel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lietuvos filialasPhone: +370 5 269 16 50 |
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| Czech RepublicNovartis s.r.oPhone: +420 225 775 111 | MagyarországNovartis Hungária Kft.Tel.: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A/SPhone: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Phone: +356 2122 2872 |
| DeutschlandNovartis Pharma GmbHPhone: +49 911 273 0 | The NetherlandsNovartis Pharma BVPhone: +31 88 04 52 111 |
| EstoniaSIA Novartis Baltics Eesti branch phone: +372 66 30 810 | NorwayNovartis Norway iPhone: +47 23 05 20 00 |
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| SpainNovartis Farmacéutica, SAPhone: +34 93 306 42 00 | PolishNovartis Poland Sp. z o. iPhone: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Produtos Farmacêuticos, SAPhone: +351 21 000 8600 |
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| ItalyNovartis Pharma SpAPhone: +39 02 96 54 1 | Finland/FinlandNovartis Finland OyTel: +358 (0)10 6133 200 |
| CyprusNovartis Pharma Services Inc.Phone: +357 22 690 690 | SwedenNovartis Sweden ABPhone: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsPhone: +371 67 887 070 | United Kingdom (Northern Irelan |