Deoxycholic acid

KYBELLA ® is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limitations of U se KYBELLA is not approved for the treatment of subcutaneous fat outside the submental region, and such use is not recommended. KYBELLA is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limit ation s of Use KYBELLA is not approved for the treatment of subcutaneous fat outside the submental region, and such use is not recommended.

KYBELLA is a cytolytic drug, which when injected into submental fat - in patients with moderate to severe convexity or fullness associated with submental fat - physically destroys the cell membrane causing lysis.

Inject KYBELLA into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm 2 (a single treatment of up to 100 mg (up to a total of 10 mL)) that consists of up to a maximum of 50 subcutaneous injections, (2 mg (0.2 mL)) each, spaced 1 cm apart. Up to 6 single treatments may be administered at intervals no less than 1-month apart. Consider use of ice/cold packs, topical and/or injectable local anesthesia (e.g., lidocaine) to enhance patient comfort. Outline the planned KYBELLA treatment area with a surgical pen and apply a 1 cm injection grid to mark the injection sites. See Full Prescribing Information for additional administration instructions. Figure 1. Avoid the Marginal Mandibular Nerve Area Figure 2. Sagittal View of Platysma Area Figure 3. Injection Pattern

KYBELLA is contraindicated in patients with an infection in the injection area. KYBELLA is contraindicated in patients with an infection at the injection area.

AND PR E CAUTIONS Marginal Mandibular Nerve Injury: Follow injection technique and do not inject KYBELLA into or in close proximity to the marginal mandibular branch of the facial nerve to avoid this injury. Dysphagia: May occur with KYBELLA use. Avoid use in patients with pre-existing dysphagia because use may exacerbate the condition. Injection Site Reactions: Hematoma/Bruising: Use KYBELLA with caution in patients with bleeding abnormalities (e.g., taking antiplatelet or anticoagulant therapy). Alopecia: Consider withholding subsequent KYBELLA treatments until resolution. Ulceration, Necrosis, Nodule, Mass, and Infection: Discontinue KYBELLA if patients develop injection site ulceration, necrosis, nodule, mass, or infection after KYBELLA administration.

The most common adverse reactions (>20% of subjects) include injection site edema/swelling, hematoma, pain, numbness, erythema and induration. 6. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, placebo-controlled clinical trials 513 subjects were treated with KYBELLA and 506 subjects were treated with placebo. Subjects received up to 6 treatments at least 1 month apart and were followed for up to 6 months after the last received treatment. The most commonly reported adverse reactions are listed below ( Table 1 ). Table 1.

Store at 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C to 30°C (59°F to 86°F).