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Kybella®

Clinical Results

Key findings from the KYBELLA® clinical trials include:1

  • KYBELLA® achieved all primary and secondary efficacy endpoints in the reduction of submental fullness with a high degree of statistical significance (p<0.001)
  • 68.2% of patients treated with KYBELLA® were ≥1-grade composite responders compared to 20.5% of placebo treated patients based upon validated physician and patient measurements
  • 16% of patients experienced a ≥2-grade improvement with KYBELLA®, compared to 2% of patients who responded to placebo, based on validated physician and patient measurements
  • KYBELLA® treatment resulted in high patient satisfaction – 79% of KYBELLA®-treated patients reported satisfaction with their appearance in association with their face and chin
  • Marginal mandibular nerve (MMN) injury occurred in 4% of subjects. To avoid the potential for nerve injury, do not inject KYBELLA® into or in close proximity to the marginal mandibular branch of the facial nerve. Dysphagia occurred in 2% of subjects. Avoid use of KYBELLA® in patients with a current or prior history of dysphagia as treatment may exacerbate the condition. Bruising occurred in 72% of subjects. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy.
  • The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration

See detailed Important Safety Information here.

ABOUT KYBELLA®

KYBELLA® is the first and only FDA approved injectable drug that contours and improves the appearance of submental fullness.

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BEFORE
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AFTER

Before & Afters

See results of patients treated with KYBELLA®. Individual results may vary.

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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.

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