FASENRA SOLUTION FOR INJECTION 30MG/ML (PRE-FILLED SYRINGE)

INJECTION, SOLUTION

**4.2 Posology and method of administration** **Posology** The recommended dose is 30 mg of FASENRA by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter. 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 exacerbation control and blood eosinophil counts. **_Paediatric population_** Available data of FASENRA in adolescents aged 12 to less than 18 years are described in section 5.1, however no posology recommendations can be made – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. The safety and efficacy of FASENRA in children aged less than 12 years have not been established. **_Elderly patients_** No dose adjustment is required for elderly patients (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Renal and hepatic impairment_** No dose adjustment is required for patients with renal or hepatic impairment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** FASENRA is administered as a subcutaneous injection. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended (see section 4.4, Hypersensitivity Reactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Administer FASENRA into the thigh, or abdomen. If somebody else administers the injection, the upper arm can also be used. Do not administer into areas where the skin is tender, bruised, erythematous, or hardened. A patient may self-inject FASENRA or the patient’s caregiver may administer FASENRA if their healthcare professional determines it is appropriate. However, the healthcare professional should ensure appropriate initiation and follow-up of patients. Proper training in subcutaneous injection technique using the prefilled syringe should be provided according to the ‘Instructions for Use’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.