Drug updated on 3/28/2024
Dosage Form | Injection (subcutaneous; 10 mg/mL) |
Drug Class | Cytolytic agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults
Summary
- Deoxycholic acid (Kybella) is indicated for the improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
- A total of 8 systematic reviews/meta-analyses were reviewed, providing insights into Kybella's efficacy and safety profile.
- The application of deoxycholic acid has been found effective in reducing submental fat and improving patient satisfaction concerning their facial appearance, as reported across multiple studies included within these documents.
- Despite its effectiveness, some adverse effects such as fibrosis, pain, erythema, numbness swelling edema pruritus nodules headache paresthesia have been noted among patients treated with deoxycholic acid; however these are generally well-tolerated according to a meta-analysis study.
- In comparison to other treatments like submental liposuction for instance - one review pointed out that while clinical trials demonstrated functional drug efficacy for Kybella it may not be cost-effective due to large volume usage per treatment session making it potentially more suitable only for patients requiring smaller doses over fewer sessions.
- Off-label uses of injectable deoxycholic acid have also shown promising results with high preliminary efficacies but further high-level studies demonstrating consistent treatment regimens and methods evaluation are recommended before definitive recommendations can be made regarding off-label use according to another review document analyzed here.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Kybella (deoxycholic acid) Prescribing Information. | 2022 | FDA |