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
Documents
Package Inserts
Nucala Solution for Injection PI.pdf
Approved: October 20, 2022