Fasenra treatment should be initiated by physicians experienced in the diagnosis and treatment of conditions for which benralizumab is indicated (see Indications/Uses).
After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see Precautions), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. Self-administration should only be considered in patients already experienced with Fasenra treatment.
Posology: Fasenra is intended for long-term treatment. A decision to continue the therapy should be made at least annually based on disease severity, level of disease control and blood eosinophil counts.
Asthma: 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.
EGPA: The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks. Patients who develop life-threatening manifestations of EGPA should be evaluated for the need for continued therapy, as Fasenra has not been studied in this population.
Missed Dose: 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.
Elderly: No dose adjustment is required for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Renal and hepatic impairment: No dose adjustment is required for patients with renal or hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Fasenra in children and adolescents aged 6 to 17 years with asthma has not been established.
Currently limited data in children 6 to 11 years old and data in adolescents aged 12 to 17 are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
The safety and efficacy of Fasenra in children less than 6 years with asthma have not been established. No data are available.
The safety and efficacy of Fasenra in children and adolescents less than 18 years with EGPA have not been established.
Method of administration: Fasenra is administered as a subcutaneous injection.
It should be injected into the thighs, 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.
Comprehensive instructions for administration using the pre-filled syringe (Fasenra) are provided in the 'Instructions for Use' under Patient Counselling Information.
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