Active Ingredient: Omalizumab
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.
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.
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:
Subcutaneous
75 - 600 mg
From 75 To 600 mg once every 14 day(s)
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 in 1 to 4 injections 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 Table 1 for a conversion chart and Tables 2 and 3 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. Conversion from dose to number of syringes, number of injections and total injection volume for each administration:
| Dose (mg) | Number of syringes | Number of injections | Total injection volume (ml) | |
|---|---|---|---|---|
| 75 mg | 150 mg | |||
| 75 | 1 | 0 | 1 | 0.5 |
| 150 | 0 | 1 | 1 | 1.0 |
| 225 | 1 | 1 | 2 | 1.5 |
| 300 | 0 | 2 | 2 | 2.0 |
| 375 | 1 | 2 | 3 | 2.5 |
| 450 | 0 | 3 | 3 | 3.0 |
| 525 | 1 | 3 | 4 | 3.5 |
| 600 | 0 | 4 | 4 | 4.0 |
Table 2. ADMINISTRATION EVERY 4 WEEKS. omalizumab doses (milligrams per dose) administered by subcutaneous injection every 4 weeks:
Table 3. ADMINSTRATION EVERY 2 WEEKS. omalizumab doses (milligrams per dose) administered by subcutaneous injection every 2 weeks:
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 omalizumab 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 omalizumab 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 omalizumab has been interrupted for one year or more.
Doses should be adjusted for significant changes in body weight (see Tables 2 and 3).
Subcutaneous
75 - 600 mg
From 75 To 600 mg once every 28 day(s)
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 in 1 to 4 injections 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 Table 1 for a conversion chart and Tables 2 and 3 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. Conversion from dose to number of syringes, number of injections and total injection volume for each administration:
| Dose (mg) | Number of syringes | Number of injections | Total injection volume (ml) | |
|---|---|---|---|---|
| 75 mg | 150 mg | |||
| 75 | 1 | 0 | 1 | 0.5 |
| 150 | 0 | 1 | 1 | 1.0 |
| 225 | 1 | 1 | 2 | 1.5 |
| 300 | 0 | 2 | 2 | 2.0 |
| 375 | 1 | 2 | 3 | 2.5 |
| 450 | 0 | 3 | 3 | 3.0 |
| 525 | 1 | 3 | 4 | 3.5 |
| 600 | 0 | 4 | 4 | 4.0 |
Table 2. ADMINISTRATION EVERY 4 WEEKS. omalizumab doses (milligrams per dose) administered by subcutaneous injection every 4 weeks:
Table 3. ADMINSTRATION EVERY 2 WEEKS. omalizumab doses (milligrams per dose) administered by subcutaneous injection every 2 weeks:
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 omalizumab 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 omalizumab 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 omalizumab has been interrupted for one year or more.
Doses should be adjusted for significant changes in body weight (see Tables 2 and 3).
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