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HSA Approval

NUCALA POWDER FOR SOLUTION FOR INJECTION 100mg

SIN15396P

NUCALA POWDER FOR SOLUTION FOR INJECTION 100mg

NUCALA POWDER FOR SOLUTION FOR INJECTION 100mg

December 14, 2017

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

Formulation Information

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**Dosage and Administration** Pharmaceutical form: Powder for solution for infusion. _NUCALA_ should be administered by a health care professional. _NUCALA_ should be prescribed by physicians experienced in the diagnosis and treatment of severe eosinophilic asthma. Following reconstitution, _NUCALA_ should only be administered as a subcutaneous injection (e.g. upper arm, thigh, or abdomen) (see _Use and Handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Populations** **Adults and Adolescents (12 years and older)** The recommended dose is 100 mg of _NUCALA_ administered by subcutaneous (SC) injection once every 4 weeks. **Children (up to 12 years of age)** The safety and efficacy of _NUCALA_ have not been established in children less than 12 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_).

SUBCUTANEOUS

Medical Information

**Indications** _NUCALA_ is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 12 years and older (see _Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

**Contraindications** Hypersensitivity to mepolizumab or to any of the excipients.

R03DX09

mepolizumab

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

GlaxoSmithKline Manufacturing S.p.A.,

Active Ingredients

Mepolizumab

100mg/vial

Mepolizumab

Documents

Package Inserts

Nucala Powder for solution for infusion PI.pdf

Approved: March 16, 2021

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