Omalizumab (CRSwNP)

Chronic rhinosinusitis with nasal polyps (CRSwNP) and allergic asthma follow the same dosing principles: the appropriate dose and frequency are determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Based on these measurements, 75 to 600 mg of omalizumab in 1 to 4 injections may be needed for each administration (§4.2). IMPORTANT: the numeric cells of dose-determination Table 2 (administration every 4 weeks) and Table 3 (administration every 2 weeks) were NOT captured in the fetched text — the clinician must read the dose tables directly from the SPC to assign an individual dose. Patients whose baseline IgE levels or body weight fall outside the limits of the dose table should not be given omalizumab; body weights below 30 kg were not studied in the pivotal CRSwNP trials. Doses should be adjusted for significant changes in body weight. Total IgE is elevated during treatment and for up to one year after stopping, so re-testing during treatment cannot guide dosing; after interruptions of less than one year use the original IgE result, and re-test only if treatment has been interrupted for one year or more. In CRSwNP, changes in nasal polyp and nasal congestion scores were observed at 4 weeks and the need for continued therapy should be reassessed periodically. Safety and efficacy in CRSwNP below 18 years of age have not been established. Treatment should be initiated by physicians experienced in the relevant conditions; the first 3 doses must be administered by or under the supervision of a healthcare professional, and patients with no known history of anaphylaxis may self-inject from the 4th dose onwards if the physician agrees. Where more than one injection is needed, divide injections across two or more sites. Other indication in the same SPC: chronic spontaneous urticaria — 300 mg by subcutaneous injection every four weeks (dosing not based on IgE or weight). Source product: Xolair 150 mg solution for injection in pre-filled syringe (UK SPC); US labelling agrees on 75-600 mg SC every 2 or 4 weeks for CRSwNP, by total IgE and body weight.