An injectable drug to improve the appearance of moderate to severe submental fullness – also referred to as “double-chin”.
Four 2.0 mL vials per box.
Composition:
- Each 2 mL vial of KYBELLA® (deoxycholic acid) injection contains 20 mg synthetic deoxycholic acid as the active ingredient and the following inactive ingredients: benzyl alcohol (18 mg), dibasic sodium phosphate (2.84 mg), sodium chloride (8.76 mg), sodium hydroxide (2.86 mg) in water to adjust the formulation to pH 8.3.
Treatment Area:
- Submental area in adult patients with moderate to severe convexity or fullness associated with submental fat.
Indication
KYBELLA® (deoxycholic acid) injection is indicated for the 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 subcutaneousÂ
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.
To avoid potential tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trial resolved spontaneously (range 1-298 days, median 44 days).
Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA® in these patients as current or prior history of dysphagia may exacerbate the condition.
In clinical trials, the 72% of subjects treated with KYBELLA® experienced injection site 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.
