Omalizumab

For use from the age of 12 for chronic spontaneous urticaria (CSU) where there has been an inadequate response to H1 antihistamines, administered at four times the usual dose for a duration of 4–6 weeks.

Severe allergic asthma resistant to other treatments (from the age of 12).

Nasal polyps (from 18 years of age).

Yes

Chronic spontaneous urticaria (CSU) in adults and adolescents (aged 12 years and over) who have responded inadequately to treatment with H1 antihistamines

Prescription/indication to be provided exclusively by a specialist in allergology and clinical immunology or dermatology and venereology.

Solution for injection in a pre-filled syringe.

No screening required

Allergic reactions, anaphylaxis, Churg-Strauss syndrome and hypereosinophilic syndrome, immunogenicity, cerebrovascular diseases, parasitic (worm) infections, malignancies.

150–300 mg every 4 weeks; if the patient responds, the dose may be reduced or the dosing interval extended.

After 12–16 weeks.

Monitoring is required for a period of two hours following the first injection (CAVE: hypotension), and for 60 minutes following all subsequent injections to prevent allergic reactions.

Most anaphylactic reactions occurred during the first 3 administrations of Xolair. Therefore, the first 3 doses must be administered by healthcare professionals or under their supervision.

In patients with a history of anaphylaxis, Xolair must be administered by healthcare professionals, as there is an increased risk of recurrent anaphylaxis.

447 (standard dose 150 mg), 10,748 (annual cost at 300 mg every 4 weeks).

Discontinue or reduce the dose after 3 months if symptoms have resolved: either extend the injection intervals to 6 weeks for a period of 12 weeks, or reduce the dose to 150 mg every 4 weeks.

Rare, low antibody titres of approximately <0.1 %.

Hypersensitivity to any of the active substances. Pregnancy: no data available; however, if the medicine was well tolerated prior to pregnancy, it may be possible to continue treatment in cases of severe urticaria, in close collaboration with the treating gynaecologist, following a strict assessment of the indication, full information and the patient’s written consent.

Occasional: fatigue; extremely rare: headache, abdominal pain, erythema, pruritus, swelling, elevated temperature (pyrexia), anaphylaxis.

Unlikely to increase the risk; discuss with infectious disease specialists.

No increased risk; discuss with infectious disease specialists.

No enzyme induction.

As IgE may be involved in the immune response to some worm infections, omalizumab may indirectly reduce the efficacy of medicines used to treat worm or other parasitic infections.

Not proven