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Posology: Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP): Dosing for allergic asthma and CRSwNP follows the same dosing principles. The appropriate dose and frequency of Xolair for these conditions is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Prior to administration of the initial dose, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment. Based on these measurements, 75 to 600 mg of Xolair in 1 to 4 injections may be needed for each administration.
Allergic asthma patients with baseline IgE lower than 76 IU/ml were less likely to experience benefit (see Pharmacology: Pharmacodynamics under Actions). Prescribing physicians should ensure that adult and adolescent patients with IgE below 76 IU/ml and children (6 to <12 years of age) with IgE below 200 IU/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
See Tables 5 and 6 for a conversion chart and Tables 7 and 8 for the dose determination charts.
Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should not be given Xolair.
The maximum recommended dose is 600 mg omalizumab every two weeks. (See Tables 3, 4, 5, and 6.)
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Click on icon to see table/diagram/imageTreatment duration, monitoring and dose adjustments: Allergic asthma: Xolair is intended for long-term treatment. Clinical trials have demonstrated that it takes at least 12-16 weeks for Xolair treatment to show effectiveness. At 16 weeks after commencing Xolair therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered. The decision to continue Xolair following the 16-week timepoint, or on subsequent occasions, should be based on whether a marked improvement in overall asthma control is seen (see Pharmacology: Pharmacodynamics: Physician's overall assessment of treatment effectiveness under Actions).
Chronic rhinosinusitis with nasal polyps (CRSwNP): In clinical trials for CRSwNP, changes in nasal polyps score (NPS) and nasal congestion score (NCS) were observed at 4 weeks. The need for continued therapy should be periodically reassessed based upon the patient's disease severity and level of symptom control.
Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP): Discontinuation of Xolair treatment generally results in a return to elevated free IgE levels and associated symptoms. Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination. Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more.
Doses should be adjusted for significant changes in body weight (see Tables 7 and 8).
Chronic spontaneous urticaria (CSU): The recommended dose is 300 mg by subcutaneous injection every four weeks.
Prescribers are advised to periodically reassess the need for continued therapy.
Clinical trial experience of long-term treatment in this indication is described in Pharmacology: Pharmacodynamics under Actions.
Special populations: Elderly (65 years of age and older): There are limited data available on the use of Xolair in patients older than 65 years but there is no evidence that elderly patients require a different dose from younger adult patients.
Renal or hepatic impairment: There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of omalizumab. Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment. While no particular dose adjustment is recommended for these patients, Xolair should be administered with caution (see Precautions).
Paediatric population: In allergic asthma, the safety and efficacy of Xolair in patients below the age of 6 years have not been established. No data are available.
In CRSwNP, the safety and efficacy of Xolair in patients below the age of 18 years have not been established.
In CSU, the safety and efficacy of Xolair in patients below the age of 12 years have not been established.
Method of administration: For subcutaneous administration only. Xolair must not be administered by the intravenous or intramuscular route.
Doses of more than 150 mg (Tables 3 and 4) should be divided across two or more injection sites.
Patients with no known history of anaphylaxis may self-inject Xolair or be injected by a caregiver from the 4th dose onwards if a physician determines that this is appropriate (see Precautions). The patient or the caregiver must have been trained in the correct injection technique and the recognition of the early signs and symptoms of serious allergic reactions.
Patients or caregivers should be instructed to inject the full amount of Xolair according to the instructions provided in the package leaflet.
