FDA approved Kybella (deoxycholic acid) for Submental Fat Reduction in AdultsFDA approved Kybella Injection to Reduce Double Chin in Adults

Deoxycholic acid is a cytolytic drug. The exact mechanism of action in reducing submental fat is not fully described in the label, but it is injected into subcutaneous fat tissue to cause lysis of fat cells.

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.

Kybella is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm2. A single treatment consists of up to a maximum of 50 injections, 0.2 mL each (up to a total of 10 mL), spaced 1 cm apart. Up to 6 single treatments may be administered at intervals no less than 1 month apart. Kybella should be administered by a healthcare professional. Use ice/cold packs, topical and/or injectable local anesthesia (e.g., lidocaine) may enhance patient comfort. Outline the planned treatment area with a surgical pen and apply a 1 cm injection grid. Inject 0.2 mL into the pre-platysmal fat next to each marked site using a 30 gauge (or smaller) 0.5 inch needle, advancing perpendicular to the skin. Avoid injections above the inferior border of the mandible and within a region defined by a 1-1.5 cm line below the inferior border (from the angle of the mandible to the mentum) to avoid injury to the marginal mandibular nerve. Do not inject into the platysma or post-platysmal fat. Injections that are too superficial (into the dermis) may result in skin ulceration and necrosis. Do not withdraw the needle during injection. If resistance is met, withdraw the needle to an appropriate depth before injecting.

Trial data not available in label.

Avoid injections near the area of the marginal mandibular nerve. Injury to the nerve presents as an asymmetrical smile due to paresis of lip depressor muscles. Do not inject above the inferior border of the mandible. Do not inject within a region defined by a 1-1.5 cm line below the inferior border (from the angle of the mandible to the mentum). Inject only within the target submental fat treatment area. Avoid injection into the platysma. Avoid injecting into other tissues such as the muscle, salivary glands, lymph nodes, and post-platysmal fat. Injections that are too superficial (into the dermis) may result in skin ulceration and necrosis. Do not withdraw the needle from the subcutaneous fat during injection as this could increase the risk of intradermal exposure and potential skin ulceration and necrosis. If at any time resistance is met as the needle is inserted, indicating the possibility of contact with fascial or nonfat tissue, the needle must be withdrawn to an appropriate depth before the injection is administered. Give careful consideration to the use of Kybella in patients with excessive skin laxity, prominent platysmal bands or other conditions for which reduction of submental fat may result in an aesthetically undesirable outcome. Use caution in patients who have had prior surgical or aesthetic treatment of the submental area. Screen patients for other potential causes of submental convexity/fullness (e.g., thyromegaly and cervical lymphadenopathy).

Kybella is a nonsurgical option for adults with moderate to severe submental fullness. It is administered by healthcare professionals in up to 6 treatment sessions. It is not recommended for use outside the submental region. Patient selection should consider skin laxity, platysmal bands, and prior submental procedures.