Kybella is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness due to submental fat.
Kybella 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. Treatments will reduce a double chin and contour the jawline with minimal downtime.
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. Kybella causes the destruction of fat cells when injected in their general area. Once destroyed, those cells cannot store or accumulate fat contents. After the aesthetic response is achieved, retreatment with Kybella is not expected.
To avoid potential tissue damage, Kybella should not be injected into or in close proximity (1-1.5 cm) to the marginal mandibular nerve, salivary glands, lymph nodes and muscles.
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.
