BELKYRA INJECTION 10 MG/ML FOR SUBCUTANEOUS USE

Product Information

Registration Status: Active

BELKYRA INJECTION 10 MG/ML is approved to be sold in Singapore with effective from 2018-06-21. It is marketed by ALLERGAN SINGAPORE PTE LTD, with the registration number of SIN15509P.

This product contains Deoxycholic Acid 10mg/mL in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.

This product is manufactured by Hospira in UNITED STATES.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Description

Deoxycholic acid is a a bile acid which emulsifies and solubilizes dietary fats in the intestine, and when injected subcutaneously, it disrupts cell membranes in adipocytes and destroys fat cells in that tissue. In April 2015, deoxycholic acid was approved by the FDA for the treatment submental fat to improve aesthetic appearance and reduce facial fullness or convexity. It is marketed under the brand name Kybella by Kythera Biopharma and is the first pharmacological agent available for submental fat reduction, allowing for a safer and less invasive alternative than surgical procedures.

Indication

For improvement in appearance of moderate to severe fullness associated with submental fat in adults.

Mechanism of Action

As a bile acid, deoxycholic acid emulsifies fat in the gut. Synthetically derived deoxycholic acid, when injected, stimulates a targeted breakdown of adipose cells by disrupting the cell membrane and causing adipocytolysis. This results in an inflammatory reaction and clearing of the adipose tissue remnants by macrophages. Deoxycholic acid's actions are reduced by albumin and tissue-associated proteins, therefore its effect is limited to protein-poor subcutaneous fat tissue. Protein-rich tissues like muscle and skin are unaffected by deoxycholic acid, contributing to its safety profile.

Pharmacokinetics

Absorption: Deoxycholic acid is rapidly absorbed after subcutaneous administration. After maximum recommended single treatment dose, 100mg, the post-treatment plasma levels returned to endogenous levels within 24 hours. With the proposed treatment guideline, no accumulation is expected.
Distribution
Metabolism: Deoxycholic acid is not metabolized to any significant extent under normal conditions.
Elimination

Active Ingredient/Synonyms

Source of information: Drugbank (External Link). Last updated on: 3^rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.