Active Ingredient: Benralizumab
Benralizumab is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 30 milligrams benralizumab, once every 4 weeks, 3 doses in total. Afterwards, subcutaneous, 30 milligrams benralizumab, once every 8 weeks.
The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. If an injection is missed on the planned date, dosing should resume as soon as possible on the indicated regimen; a double dose must not be administered.
Benralizumab is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on disease severity, level of exacerbation control and blood eosinophil counts.
It should be injected into the thigh or abdomen. If the healthcare professional or caregiver administers the injection, the upper arm can also be used. It should not be injected into areas where the skin is tender, bruised, erythematous, or hardened.
For:
Regimen A: In case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≤ 35 kg, subcutaneous, 10 milligrams benralizumab, once every 4 weeks, 3 doses in total. Afterwards, in case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≤ 35 kg, subcutaneous, 10 milligrams benralizumab, once every 8 weeks.
Regimen B: In case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 35 kg, subcutaneous, 30 milligrams benralizumab, once every 4 weeks, 3 doses in total. Afterwards, in case that patient age in years is ≥ 6 and patient age in years is ≤ 11 and patient weight is ≥ 35 kg, subcutaneous, 30 milligrams benralizumab, once every 8 weeks.
The recommended dosage of benralizumab for pediatric patients 6 to 11 years of age is based on body weight as provided in the followinf table.
Recommended dosage of benralizumab in pediatric patients 6 to 11 years of age:
| Body weight | Recommended dosage |
|---|---|
| Less than 35 kg | 10 mg (one injection) administered subcutaneously every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. |
| 35 kg or more | 30 mg (one injection) administered subcutaneously every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. |
Administer benralizumab into the thigh or abdomen. The upper arm can also be used if a healthcare provider or caregiver administers the injection.
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