Agent and target | US FDA-approved age | Approved indication¶ | Route | Dose | Dosing interval | Adverse effects |
Omalizumab (anti-IgE) | ≥6 years | IgE 30 to 700 int. units/mL in United States; 30 to 1500 int. units/mL in Europe | SCΔ | Based on weight and IgE Doses ≥225 mg need to be divided over >1 injection site Maximal dose: 375 mg every 2 weeks in United States; 600 mg every 2 weeks in Europe | 2 to 4 weeks depending on IgE level and body weight |
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Mepolizumab (anti-IL-5) | ≥6 years | Peripheral blood eosinophils ≥150/microL | SCΔ | Adults and adolescents: 100 mg Children age 6 to 11 years: 40 mg | 4 weeks |
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Benralizumab (anti-IL-5 receptor alpha) | ≥6 years | Peripheral blood eosinophils ≥150/microL | SC | Adults and adolescents: 30 mg Children age 6 to 11 years: 10 mg, for children weighing <35 kg; 30 mg, for children weighing ≥35 kg | 4 weeks for first 3 doses, then 8 weeks |
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Dupilumab (anti-IL-4 receptor subunit alpha)§ | ≥6 years | Peripheral blood eosinophils ≥150/microL | SCΔ | Adults and adolescents: First week, 400 mg once (given as two 200 mg injections), then 200 mg Children age 6 to 11 years: 300 mg◊, for children weighing 15 to <30 kg; 200 mg, for children weighing ≥30 kg | Adults, adolescents, and children weighing ≥30 kg: 2 weeks Children age 6 to 11 weighing 15 to 30 kg: 4 weeks |
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First week, 600 mg once (given as two 300 mg injections), then 300 mg§ | 2 weeks | |||||
Reslizumab (anti-IL-5) | ≥18 years | Peripheral blood eosinophils ≥400/microL | IV | 3 mg/kg | 4 weeks |
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Tezepelumab | ≥12 years | No additional requirements | SCΔ | 210 mg | Every 4 weeks |
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FEV1: forced expiratory volume in one second; IgE: total serum immunoglobulin E; IL-5: interleukin-5; IV: intravenous infusion; SC: subcutaneous injection; TSLP: thymic stromal lymphopoietin; US FDA: United States Food and Drug Association.
* Helminth infection should be excluded or treated prior to initiation of therapy. These agents should be administered in a setting prepared to handle anaphylaxis. Patients should be observed for two hours after each of the first three injections and for 30 minutes after each subsequent injection. It is advised that patients receiving omalizumab should carry an epinephrine autoinjector for at least 24 hours after each injection due to late occurrences of anaphylaxis.
¶ This column notes indications in addition to the diagnosis of poorly controlled severe asthma despite inhaled therapies, which is required for all biologic agents.
Δ Mepolizumab, dupilumab, and tezepelumab can be administered at home after appropriate training. Omalizumab is available for home administration in some countries, including the United States. Refer to UpToDate content for additional information.
◊ For children age 6 to 11 years 15 to <30 kg with severe asthma, dupilumab is dosed 300 mg every four weeks. Alternative dosing regimens are used for moderate to severe atopic dermatitis.
§ The higher dose of dupilumab is advised for adults or adolescents with oral glucocorticoid-dependent asthma or comorbid moderate to severe atopic dermatitis.Do you want to add Medilib to your home screen?