Kybella™ (Deoxycholic Acid) lnjection
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™, (deoxycholic acid) for treatment of subcutaneous fat outside the submental region has not been established.
lmportant Safety information:
Kybella™ should only be administered by a trained healthcare professional.
Kybella™ is contraindicated in the presence of infection at the injection site.
Avoid injecting in proximity to vulnerable anatomic structures due to increased risk of tissue damage.
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 trials 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, 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 (1-1.5cm) 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.
I have discussed the risks and benefits of the Kybella™ treatment with my physician and/or his representative, and they have answered my questions. I understand the information provided.
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Document Name: Kybella™ (Deoxycholic Acid) lnjection
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