- Approval Id
- b01ec688a8a92b1a
- Drug Name
- NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.4ML
- Product Name
- NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.4ML
- Approval Number
- SIN16811P
- Approval Date
- 2023-06-19
- 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 40 mg/0.4 mL 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_ should be prescribed by physicians experienced in the diagnosis and treatment of severe eosinophilic asthma.
_NUCALA_ must be administered by a healthcare professional or a caregiver. It may be administered by a caregiver if a healthcare professional determines that it is appropriate, and the caregiver is trained in injection techniques.
**Populations**
**Severe Eosinophilic asthma**
**Children aged 6 to 11 years old:**
The recommended dose is 40 mg of _NUCALA_ administered by subcutaneous (SC) injection once every 4 weeks.
The safety and efficacy of _NUCALA_ have not been established in children less than 6 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**
**Severe Eosinophilic Asthma**
_NUCALA_ is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 6 to 11 years old (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/cac9b4e7bceb9ea7/glaxosmithkline-pte-ltd
