KYBELLA® is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness.
Patients asking about their submental fullness may, at times, refer to it as their “double chin.”
It is a common, yet under treated facial aesthetic condition that can:
- Detract from an otherwise balanced and harmonious facial appearance1
- Lead to an older and heavier look2
- Impact a broad range of adults, including both women and men
- Be caused by aging, genetics and/or weight gain3>
KYBELLA® (deoxycholic acid) injection 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.
Important Safety Information
KYBELLA® should only be administered by a trained healthcare professional.
KYBELLA® is contraindicated in the presence of infection at the injection sites.
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported in 4% of subjects in the clinical trials. KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve; all cases resolved spontaneously (range 1-298 days, median 44 days).
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area; all cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Avoid use of KYBELLA® in these patients as current or prior history of dysphagia may exacerbate the condition.
In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.