Omalizumab

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.

Common side effects:

• Fever

• Reactions at the injection site including pain, swelling, itching and redness

• Pain in the upper part of the tummy

• Headache

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

Serious, but 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 heartbeat, dizziness and lightheadedness, shortness of breath, wheezing or trouble breathing, or any other new symptoms, tell your doctor or nurse immediately.

• 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 “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.

Talk to your doctor before you are given Omalizumab:

• If you are allergic to omalizumab or any of the other ingredients of this medicine (L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, Polysorbate 20 and latex).
• If you have kidney or liver problems.
• If you have a disorder where your own immune system attacks parts of the body (autoimmune disease).
• If you are travelling to such a region where infections caused by parasites are common as Omalizumab may weaken your resistance to such infections.

Your doctor will work out how much Omalizumab 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.

Omalizumab will be given to your child by a doctor or nurse as an injection under the skin (subcutaneously).

Your child may be given 1 to 4 injections at a time, either every two weeks, or every four weeks.

Ensure that your child continues taking his or her current medicines during Omalizumab treatment. Do not stop taking any medicines without talking to your doctor.

You may not see an immediate improvement in your asthma or CSU after beginning Omalizumab therapy. It usually takes between 12 and 16 weeks to have the full effect.

Tell your doctor, pharmacist or nurse if you are taking, has 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.

Do not stop Omalizumab treatment unless your doctor tells you to. Interrupting or stopping treatment with Omalizumab may cause your symptoms to come back.