- Approval Id
- 7d1d905ead40d2f1
- Drug Name
- NUCALA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
- Product Name
- NUCALA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
- Approval Number
- SIN16172P
- Approval Date
- 2021-04-27
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **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_).
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- **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
- **Contraindications**
Hypersensitivity to mepolizumab or to any of the excipients.
- Atc Code
- R03DX09
- Atc Item Name
- mepolizumab
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/glaxosmithkline-pte-ltd
