This site is intended for U.S. Healthcare Professionals. Menu This site is intended for U.S. Healthcare Professionals.
Welcome,
About

Kybella®

Clinical Study Design

KYBELLA® has been the focus of a global clinical development program involving over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA® .1

In North America, two randomized, multi-center, double-blind, Phase III pivotal trials of identical design were conducted to evaluate KYBELLA® (N=514, combined trials) vs. placebo (N=508, combined trials) for the reduction of moderate to severe submental fullness.2

CLINICAL STUDY DESIGN

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® 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; all cases resolved spontaneously (range 1-298 days, median 44 days). KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.

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 resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment 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.

Report side effects to the FDA at 1-800-FDA-1088 or Allergan Medical Information at 800-433-8871.

FORGOT PASSWORD

Username or E-mail




GET NEW PASSWORD
×

NEW PASSWORD





New Password



Confirm Password




SUBMIT
×