KYBELLA FAQ

KYBELLA™ FREQUENTLY ASKED QUESTIONS

Submental fullness, sometimes referred to as “double chin,” is a common, yet under-treated facial aesthetic condition. It can detract from an otherwise balanced and harmonious facial appearance – leading to an older and heavier look.
Submental fullness can impact a broad range of adults, including both women and men, and can be caused by aging, genetics and weight gain.

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 fullness associated with submental fat in adults.

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.
The fat pocket under the chin is treated with injections to the area using a very fine needle. The procedure takes approximately 15-20 minutes, and a second treatment approximately one to two months afterward is typically recommended for maximum results.

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.

The safety profile of KYBELLA™ is well-characterized.
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™.
KYBELLA™ is manufactured through a highly-controlled, FDA-regulated process and approved facility to ensure patient safety.
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. To avoid potential tissue damage, KYBELLA™ should not be injected into or in close proximity (1-1.5 cm) to the MMN, salivary glands, lymph nodes and muscles.