Regulatory Information
ABBVIE PTE. LTD.
ABBVIE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION, SOLUTION
**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_.
SUBCUTANEOUS
Medical Information
**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.
**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.
D11AX24
deoxycholic acid
Manufacturer Information
ABBVIE PTE. LTD.
Hospira, Inc.
Active Ingredients
Documents
Package Inserts
Belkyra PI.pdf
Approved: March 6, 2023