Drug reference
Prophylaxis of severe persistent allergic asthma ▶BY SUBCUTANEOUS INJECTION ▶Adult: Dose according to immunoglobulin E concentration and body-weight (consult product literature) Add-on therapy for chronic spontaneous urticaria in patients who have had an inadequate response to H1 antihistamine treatment ▶BY SUBCUTANEOUS INJECTION ▶Adult: 300 mg every 4 weeks
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Autoimmune disease. susceptibility to helminth infection—discontinue if infection does not respond to anthelmintic
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NICE decisions ▶Omalizumab for severe persistent allergic asthma (April 2013) NICE TA278 Omalizumab is recommended as an option for treating severe persistent confirmed allergic IgE-mediated asthma as an add-on to optimised standard therapy in patients aged 6 years and over: . who need continuous or frequent treatment with oral corticosteroids (defined as 4 or more courses in the previous year), and . only if the manufacturer makes omalizumab available with the discount agreed in the patient access scheme. Optimised standard therapy is defined as a full trial of and, if tolerated, documented compliance with inhaled high- dose corticosteroids, long-acting beta2 agonists, leukotriene receptor antagonists, theophyllines, oral corticosteroids, and smoking cessation if clinically appropriate. Patients currently receiving omalizumab whose disease does not meet the criteria should be able to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta278 ▶Omalizumab for previously treated chronic spontaneous urticaria (June 2015) NICE TA339 Omalizumab is an option as add-on therapy for the treatment of severe chronic spontaneous urticaria in patients 12 years and over, only if: . the severity of the condition is assessed objectively, for example, using a weekly urticaria activity score of 28 or more, . the patient’s condition has not responded to standard treatment with H1-antihistamines and leukotriene receptor antagonists, . omalizumab is stopped at or before the fourth dose if the condition has not responded, . omalizumab is stopped at the end of a course of treatment (6 doses) if the condition has responded and is restarted only if the condition relapses, . omalizumab is administered under the management of a secondary care specialist in dermatology, immunology or allergy, . the manufacturer provides omalizumab with the discount agreed in the patient access scheme. Patients currently receiving omalizumab whose disease does not meet the above criteria should have the option to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta339 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (January 2015) that omalizumab (Xolair ®) is accepted for restricted use within NHS Scotland for the treatment of chronic spontaneous urticaria in patients aged 12 years and over, who have had an inadequate response to combination therapy with H1-antihistamines, leukotriene receptor antagonists and H2-antihistamines, used according to current treatment guidelines.
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▶Common or very common Headache. skin reactions ▶Uncommon Cough. diarrhoea. dizziness. drowsiness. dyspepsia. fatigue. flushing. increased risk of infection. influenza like illness. limb swelling. nausea. paraesthesia . photosensitivity reaction. postural hypotension. respiratory disorders. syncope. weight increased ▶Rare or very rare Angioedema. hypersensitivity. systemic lupus erythematosus (SLE) ▶Frequency not known Alopecia. eosinophilic granulomatosis with polyangiitis. immune thrombocytopenic purpura. joint disorders. lymphadenopathy. myalgia SIDE-EFFECTS, FURTHER INFORMATION Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) Churg-Strauss syndrome has occurred rarely in patients given omalizumab; the reaction is usually associated with the reduction of oral corticosteroid therapy. Churg-Strauss syndrome can present as eosinophilia, vasculitic rash, cardiac complications, worsening pulmonary symptoms, or peripheral neuropathy. Hypersensitivity reactions Hypersensitivity reactions can also occur immediately following treatment with omalizumab or sometimes more than 24 hours after the first injection.
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Manufacturer advises avoid unless essential—crosses the placenta.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises caution (no information available).
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Manufacturer advises caution—no information available.
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Xolair (Novartis Pharmaceuticals UK Ltd) Omalizumab 150 mg per 1 ml Xolair 150mg/1ml solution for injection pre-filled syringes | 1 pre-filled disposable injection P £256.15 DT = £256.15 Xolair 75mg/0.5ml solution for injection pre-filled syringes | 1 pre- filled disposable injection P £128.07 DT = £128.07
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Dose according to immunoglobulin E
First-line fragment. Read the complete Indications and Dose section above.
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300 mg every 4 weeks
First-line fragment. Read the complete Indications and Dose section above.
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