Omalizumab

Treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma, CRSwNP or chronic spontaneous urticaria. Prior to the initial dose, total serum IgE must be determined by any commercial assay for dose assignment. Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should NOT be given omalizumab. Allergic asthma patients with baseline IgE lower than 76 IU/ml were less likely to benefit; prescribers should ensure adults and adolescents with IgE below 76 IU/ml, and children 6 to under 12 years with IgE below 200 IU/ml, have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy. Dose-to-syringe conversion (SPC Table 1) for each administration: 75 mg = 1 injection (0.5 ml); 150 mg = 1 injection (1.0 ml); 225 mg = 2 injections (1.5 ml); 300 mg = 1 injection (2.0 ml); 375 mg = 2 injections (2.5 ml); 450 mg = 2 injections (3.0 ml); 525 mg = 3 injections (3.5 ml); 600 mg = 2 injections (4.0 ml). Allergic asthma is a long-term treatment: at least 12-16 weeks are needed for effectiveness, and patients should be assessed at 16 weeks for a marked improvement in overall asthma control before further injections. In CRSwNP, changes in nasal polyps score and nasal congestion score were observed at 4 weeks; reassess the need for continued therapy periodically. Total IgE levels rise during treatment and stay elevated for up to one year after stopping, so re-testing IgE during treatment cannot guide dose determination; dose after an interruption of less than one year should use the original baseline IgE, and IgE may be re-tested if treatment has been interrupted for one year or more. Doses must be adjusted for significant changes in body weight. Not indicated for acute asthma exacerbations, acute bronchospasm or status asthmaticus. Do not abruptly discontinue systemic or inhaled corticosteroids after starting omalizumab. The first 3 doses must be given by, or under the supervision of, a healthcare professional because most anaphylactic reactions occur within the first 3 doses; patients with a known history of anaphylaxis must be dosed by a healthcare professional. Patients with no known history of anaphylaxis may self-inject or be injected by a trained caregiver from the 4th dose onwards if the physician judges it appropriate. Paediatric: no per-kg dose is stated - paediatric dosing also comes from the IgE/weight tables. Safety and efficacy have not been established below 6 years in allergic asthma, below 18 years in CRSwNP, or below 12 years in CSU. The 75 mg and 150 mg pre-filled syringes may be used in children 6 to 11 years with allergic asthma; the 300 mg pre-filled syringe is not intended for use in patients under 12 years. Verify paediatric dosing against a children's formulary and the SPC tables. Product source: Omlyclo 150 mg solution for injection in pre-filled syringe.