Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 10 mg/mL) |
Drug Class | Bile acid, cytolytic drug |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
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Summary
- Kybella (deoxycholic acid) is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Deoxycholic acid (DCA) was significantly more effective than placebo in reducing submental fat (SMF), with improvements observed in both clinician-reported and patient-reported outcomes, as well as in measurements using calipers and magnetic resonance imaging. Patient satisfaction was higher at the end of a 12-week period.
- No significant differences in efficacy were observed between 1 mg/cm² and 2 mg/cm² doses of DCA for SMF reduction. The effectiveness was consistent across participants aged 46 to 49.5 years.
- DCA exhibited high preliminary efficacy (>85% success rates) for various off-label uses, including lipomas and HIV-associated lipohypertrophy, though the recommendations for these uses remain weak due to the lack of high-level studies.
- Common adverse events associated with deoxycholic acid (DCA) include injection site pain, hematoma, anesthesia/numbness, erythema, and swelling/edema, with most adverse events being transient and resolving within the treatment session interval. Severe adverse effects, though rare, include skin necrosis, nerve injury, alopecia, and vascular events, particularly with large volume injections.
- Severe, long-term adverse events, such as severe pain, alopecia, nasopharyngitis, dysphagia, dizziness/lightheadedness, and gastrointestinal upset, were noted to be rare but possible, necessitating careful dosage management and highlighting the need for further research, especially in off-label applications.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Kybella (deoxycholic acid) Prescribing Information. | 2023 | AbbVie Inc., North Chicago, IL |