Abbreviated Prescribing Information
FASENRA PEN (Benralizumab)

Presentation: Benralizumab 30 mg solution for injection in pre-filled pen. Indications: Add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose ICS/LABA. Dosage: Subcutaneous injection, 30 mg every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: Should not be used to treat acute asthma exacerbations; Seek medical advice if asthma remains uncontrolled or worsens after initiation of treatment; Abrupt discontinuation of corticosteroids after initiation of Benralizumab is not recommended. Reduction in corticosteroid doses should be gradual and performed under the supervision of a physician; Patients with pre-existing helminth infections should be treated before initiating therapy of Benralizumab. Interactions: No formal drug interaction studies have been conducted. Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of Benralizumab. Undesirable Effects: Headache, pharyngitis, hypersensitivity reactions, pyrexia and injection site reaction. Full local prescribing information is available upon request. API.HK.FAS.0521

HK-10000 19/02/2024