Omalizumab

Xolair® (Omalizumab)

Novartis

Binding to free IgE

From 12 years of age Chronic spontaneous urticaria (CSU) with inadequate response to H1 antihistamines applied in 4-fold dose for 4-6 weeks

No

Chronic spontaneous urticaria (CSU) in adults and adolescents (12 years and older) with inadequate response to treatment with H1 antihistamines, provided that treatment is prescribed by a specialist in allergology and clinical immunology or dermatology and venereology.

Lyophilisate

No screening required

Not required

Not required

Not required

s.c.

300 mg as subcutaneous injection every 4 weeks

After 1-3 months

Observation required for two hours after the first injection (CAVE: hypotension), 60 minutes for all follow-up injections to avoid allergic reactions, allow 20-30 minutes to elapse in the vortex device.

14'694.4 at standard dose 150mg: CHF 524.80

Possible

Stop or reduce dosage after 3 months if no symptoms occur: Either extend injection intervals to 6 weeks for 12 weeks, or reduce dosage to 150 mg every 4 weeks.

None known

Over-sensitivity to one of the active substances pregnancy: no data available, but with good tolerability prior to pregnancy, in the case of severe urticaria it would be possible to continue therapy in close cooperation with the treating gynaecologist after strict indication and clarification as well as written consent of the patient.

Occasionally: fatigue; extremely rare: Headache, abdominal pain, erythema, pruritus, smouldering, temperature increase (pyrexia), anaphylaxis

No information

Rather no risk increase, discuss with infectiologist

No risk increase according to literature, discuss with infectiologist

No enzyme induction, no interaction known

Not verified

Inj

systemic