- Approval Id
- eead29d9e21770b3
- Drug Name
- NUCALA POWDER FOR SOLUTION FOR INJECTION 100mg
- Product Name
- NUCALA POWDER FOR SOLUTION FOR INJECTION 100mg
- Approval Number
- SIN15396P
- Approval Date
- 2017-12-14
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- **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_).
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- **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
- **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
