KYBELLA™

Clinical pharmacology

Initial U.S. Approval: 2015

Mechanism of Action: KYBELLA is a cytolytic drug, which when injected into tissue physically destroys the cell membrane causing lysis.

Indications and usage

INDICATIONS AND USAGE:
1.1 Fullness Associated with Submental Fat
KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

1.2 Limitation of use
The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

Dosage and administration

Drug UPDATES: KYBELLA™- deoxycholic acid injection
[Drug information / PDF] Click link for the latest monograph
Dosing: Click (+) next to Dosage and Administration section (drug info link)

How supplied

HOW SUPPLIED: Injection: 10 mg/mL. KYBELLA injection is a clear, colorless, sterile solution supplied in 2 mL vials intended for single patient use. Each milliliter of the solution contains 10 mg of deoxycholic acid.

Reference

Drug UPDATES: KYBELLA™- deoxycholic acid injection
[Drug information / PDF] Click link for the latest monograph

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.