BELKYRA INJECTION 10 MG/ML

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.

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.