What is KYBELLA™ (deoxycholic acid) injection?
KYBELLA™ (deoxycholic acid) injection, also known as ATX-101, is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness due to submental fat. KYBELLA™ is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. 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.
How does KYBELLA™ work?
KYBELLA™ is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into subcutaneous fat, KYBELLA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. After the aesthetic response is achieved, retreatment with KYBELLA™ is not expected.
How is KYBELLA™ administered?
Treatment with KYBELLA™ is customized by the physician to the patient’s aesthetic goals for an improved chin profile. The safe and effective use of KYBELLA™ depends on the use of the correct number and locations for injections, proper needle placement and administration techniques. In clinical trials, the average dose administered was approximately 4 to 6 mL per treatment session. Each in-office treatment session is typically 15-20 minutes. In clinical trials, many patients experienced visible results in two to four treatment sessions spaced at least one month apart. Up to 6 treatments may be administered if needed.
What are the results of KYBELLA™?
68.2% of subjects treated with KYBELLA™ were responders compared to 20.5% of placebo-treated subjects, based upon validated physician and patient measurements. KYBELLA™ treatment resulted in high patient satisfaction – 79% of KYBELLA™-treated patients reported satisfaction with their appearance in association with their face and chin. Patients also reported improvement in the visual and emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.
What are the possible side effects with KYBELLA™?
KYBELLA™ has been the focus of a global clinical development program involving over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA™. The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration. Marginal mandibular nerve (MMN) injury occurred in 4% and dysphagia occurred in 2% of subjects.
Can I see before and after photos of Kybella treatment?
How long do the results of KYBELLA last?
KYBELLA results are permanent. Once the aesthetic response is achieved no further treatments will be required unless you gain weight. As with any cosmetic procedure, the aging process continues to occur so the regular effects of time can degrade the results.