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Kybella®

About Treatment

What to know about KYBELLA® dosing and administration:2

  • The number of injections and the number of treatments should be tailored to the individual patient’s submental fat distribution and treatment goals. Once the aesthetic response is achieved with KYBELLA®, retreatment is not expected.1
  • KYBELLA® is administered by subcutaneous injections directly into submental fat via 0.2 mL injections spaced 1cm apart using a 30G (or smaller) 0.5-inch needle
  • In clinical trials, the average dose was typically 2-3 vials (4-6 mL) per patient treatment session; no more than 10 mL per treatment session may be injected
  • In-office treatment sessions are typically 15-20 minutes
  • In clinical studies, many patients experienced visible results in two to four treatment sessions spaced at least one month apart. Up to 6 treatments may be administered
    • In clinical studies, results for KYBELLA®-treated patients who had a ≥1-grade composite improvement were 8% (1 txt), 28% (2 txt), 43% (3 txt), 55% (4 txt), 66% (5 txt) and 72% (6 txt)
    • In clinical studies, results for KYBELLA®-treated patients who had a ≥2-grade composite improvement were 0% (1 txt), .2% (2 txt), .8% (3 txt), 3.5% (4 txt), 3.9% (5 txt) and 15% (6 txt)
    • 59% of subjects in the clinical trials received all 6 treatments
  • The safe and effective use of KYBELLA® depends on the use of the correct number and locations for injections, proper needle placement, and administration techniques
  • Health care professionals administering KYBELLA® must understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures

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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