Omalizumab 150 mg solution for injection in pre-filled syringe

What Omalizumab is used for:

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. Omalizumab is used for the treatment of:
•    allergic asthma
•    chronic rhinosinusitis with nasal polyps
•    chronic spontaneous urticaria

Do not use Omalizumab:

•    if you are allergic to omalizumab or any of the other ingredients of this medicine
Warnings and precautions
Talk to your doctor before using Omalizumab:
•    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 region where infections caused by parasites are common
•    Omalizumab 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.
•    if you have ever had an allergic reaction to latex. The needle cap of the syringe may contain dry rubber (latex).

Possible side effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Omalizumab are usually mild to moderate but can occasionally be serious. Seek medical attention immediately if you notice any signs of the severe allergic reactions.
Other side effects include:
•    fever
•    reactions at the injection site
•    headache
•    upper respiratory tract infection
•    sinusitis, sinus headache
•    pain in joints
•    feeling dizzy
•    feeling sleepy
•    numbness of the hands or feet
•    low blood pressure
•    sore throat, coughing
•    acute breathing problems
•    nausea, diarrhea, indigestion
•    sensitivity of the skin to sun
•    weight increase
•    flu-like symptoms
•    swelling arms

Other medicines and Omalizumab:

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 Omalizumab may reduce the effect of your medicines,
•    inhaled corticosteroids and other medicines for allergic asthma.

How to use Omalizumab:

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure
Omalizumab is used as an injection under your skin.
Use in adults:
•    Allergic asthma and chronic rhinosinusitis with nasal polyps
•    Your doctor will decide how much Omalizumab you need and how often you will need 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 need 1 to 4 injections at a time. You will need the injections either every two weeks, or every four weeks.
•    Chronic spontaneous urticaria
•    You will need two 150 mg injections at a time every four weeks.
Use in children and adolescents
•    Allergic asthma
•    Omalizumab can be used in 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 Omalizumab your child needs and how often it needs to be given.
•    Chronic spontaneous urticaria (CSU)
•   Omalizumab can be used in adolescents aged 12 years of age and older, who are already receiving antihistamines but whose CSU symptoms are not well controlled by these medicines. The dose for adolescents aged 12 years and above is the same as for adults.

How to store Omalizumab:

•    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 the original package in order to protect from light.
•    Store in a refrigerator (2°C – 8°C). Do not freeze.
•    Do not use any pack that is damaged or shows signs of tampering.
* Dosage form and route of administration of Omalizumab 75 mg solution for injection in pre-filled syringe should be prescribed according to therapeutic indication and disease severity of each individual patient.