- Approval Id
- de727317a735dcf3
- Drug Name
- BELKYRA INJECTION 10 MG/ML
- Product Name
- BELKYRA INJECTION 10 MG/ML
- Approval Number
- SIN15509P
- Approval Date
- 2018-06-21
- Registrant
- ABBVIE PTE. LTD.
- Licence Holder
- ABBVIE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **6\. RECOMMENDED DOSE**
BELKYRA™ is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm2 (0.2 mL) per injection side.
- A single treatment consists of up to maximum of 50 injections, 0.2 mL each (up to a total of 10 mL), spaced 1 cm apart.
- The maximum dose of 100 mg (10 mL or 50 injections) should not be exceeded in one treatment session.
- Treatments should not be administered at intervals of less than 4 weeks.
- Up to 6 single treatments may be administered in clinical trials. Most patients experience improvement following 2–4 treatment sessions.
See _General Considerations for Administration (7.1) and Injection Technique (7.2)_ before injection – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- **5\. INDICATION**
5.1 Fullness Associated with Submental Fat
BELKYRA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
5.2 Limitation of use
The safe and effective use of BELKYRA™ for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
- Contraindications
- **8\. CONTRAINDICATION**
BELKYRA™ is contraindicated in the patients with the following conditions
- presence of infection at the injection sites.
- hypersensitivity to deoxycholic acid or any of the excipients.
- Atc Code
- D11AX24
- Atc Item Name
- deoxycholic acid
- Pharma Manufacturer Name
- ABBVIE PTE. LTD.
- Company Detail Path
- /organization/abbvie-pte-ltd
