NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.4ML

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

INJECTION, SOLUTION

**Dosage and Administration** Pharmaceutical form: Solution for injection in 40 mg/0.4 mL pre-filled syringe (safety syringe) _NUCALA_ should only be administered as a subcutaneous injection (see _Use and Handling and Instructions for Use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _NUCALA_ should be prescribed by physicians experienced in the diagnosis and treatment of severe eosinophilic asthma. _NUCALA_ must be administered by a healthcare professional or a caregiver. It may be administered by a caregiver if a healthcare professional determines that it is appropriate, and the caregiver is trained in injection techniques. **Populations** **Severe Eosinophilic asthma** **Children aged 6 to 11 years old:** The recommended dose is 40 mg of _NUCALA_ administered by subcutaneous (SC) injection once every 4 weeks. The safety and efficacy of _NUCALA_ have not been established in children less than 6 years of age. _**Elderly (65 years or older)**_ No dosage adjustment is recommended in patients 65 years or older (see _Pharmacokinetics – Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Renal Impairment**_ Dose adjustments in patients with renal impairment are unlikely to be required (see _Pharmacokinetics – Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Hepatic Impairment**_ Dose adjustments in patients with hepatic impairment are unlikely to be required (see _Pharmacokinetics – Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).