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HSA Approval

NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/ML

SIN16171P

NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/ML

NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/ML

April 27, 2021

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

Formulation Information

INJECTION, SOLUTION

**Dosage and Administration** Pharmaceutical form: Solution for injection in a pre-filled pen (auto-injector) Solution for injection in a 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_ may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate and the patient or caregiver are trained in injection techniques. **Populations** **Severe Eosinophilic asthma** **Adults and Adolescents (12 years and older)** The recommended dose is 100 mg of _NUCALA_ administered by subcutaneous (SC) injection once every 4 weeks. **CRSwNP** **Adults** The recommended dose is 100 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks. **Children** Use in patients less than 18 years of age is not relevant for CRSwNP. **EGPA** Injection sites should be at least 5 cm apart (see _Use and Handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Adults** The recommended dose is 300 mg of _NUCALA_ administered by subcutaneous (SC) injection once every 4 weeks. EGPA: _NUCALA_ is not indicated in patients under 18 years of age. **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. **HES** Injection sites should be at least 5 cm apart (see _Use and Handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Adults** The recommended dose is 300 mg of _NUCALA_ administered by subcutaneous (SC) injection once every 4 weeks. **Children** The safety and efficacy of _NUCALA_ have not been established in children. **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** **Severe Eosinophilic Asthma** _NUCALA_ is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 12 years and older. **Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)** _NUCALA_ is indicated as add-on maintenance treatment of severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. **Eosinophilic Granulomatosis with Polyangiitis (EGPA)** _NUCALA_ is indicated as add-on treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients. **Hypereosinophilic Syndrome (HES)** _NUCALA_ is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

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

R03DX09

mepolizumab

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

Glaxo Operations UK Ltd (Trading as Glaxo Wellcome Operations)

Active Ingredients

Mepolizumab

100mg/ml

Mepolizumab

Documents

Package Inserts

Nucala Solution for Injection PI.pdf

Approved: October 20, 2022

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