Allergic asthma
Active Ingredient: Omalizumab
Indication for Omalizumab
Population group:
only
children (1 year - 12 years old)
, adolescents (12 years - 18 years old)
, adults (18 years old or older)
Therapeutic intent: Curative procedure
Omalizumab is indicated in adults, adolescents and children (6 to <12 years of age).
Omalizumab treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.
Adults and adolescents (12 years of age and older)
Omalizumab is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Children (6 to <12 years of age)
Omalizumab is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
For this indication, competent medicine agencies globally authorize below treatments:
75-600 mg once every 4 or 2 weeks
Dosage regimens
Regimen A: In case that patient age in years is ≥ 6, subcutaneous, between 75 milligrams omalizumab and 600 milligrams omalizumab, once every 28 days.
Regimen B: In case that patient age in years is ≥ 6, subcutaneous, between 75 milligrams omalizumab and 600 milligrams omalizumab, once every 14 days.
Detailed description
The appropriate dose and frequency of omalizumab 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 omalizumab may be needed for each administration.
Patients with IgE lower than 76 IU/ml were less likely to experience benefit. 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 1 and 2 for the dose determination charts in adults, adolescents and children (6 to <12 years of age).
Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should not be given omalizumab.
The maximum recommended dose is 600 mg omalizumab every two weeks.
Table 1. ADMINISTRATION EVERY 4 WEEKS. omalizumab doses (milligrams per dose) administered by subcutaneous injection every 4 weeks:
Table 2. ADMINSTRATION EVERY 2 WEEKS. omalizumab doses (milligrams per dose) administered by subcutaneous injection every 2 weeks:
Treatment duration, monitoring and dose adjustments
Omalizumab is intended for long-term treatment. Clinical trials have demonstrated that it takes at least 12-16 weeks for omalizumab treatment to show effectiveness. At 16 weeks after commencing omalizumab therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered. The decision to continue omalizumab following the 16-week timepoint, or on subsequent occasions, should be based on whether a marked improvement in overall asthma control is seen.
Discontinuation of 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 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 has been interrupted for one year or more.
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