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MECHANISM OF ACTION

  • KYBELLA® is a nonhuman and nonanimal formulation of deoxycholic acid, a cytolytic agent1
  • Deoxycholic acid is a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat2
  • Fat cleared from the treatment area is processed through natural metabolic mechanisms3

Pharmacokinetics of deoxycholic acid from KYBELLA®
after injection

Following subcutaneous injection, KYBELLA® is rapidly absorbed into the plasma and enters the body's bile acid pool in the enterohepatic circulation, where it is then excreted along with the endogenous deoxycholic acid.1 Posttreatment deoxycholic acid plasma levels return to the endogenous range within 24 hours.1 No accumulation is expected with the proposed treatment frequency (minimum 1-month treatment intervals).1

MECHANISM OF ACTION (MOA)

KYBELLA® is a cytolytic agent that causes lysis of the adipocytes—the permanent destruction of fat cells—in the treatment area under the chin when injected into subcutaneous fat. Once destroyed, those cells cannot store or accumulate fat.1

BEFORE & AFTER

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

VIEW

INDIVIDUALLY TAILORED* KYBELLA® INJECTIONS

For adults with moderate to severe submental fat (double chin):
KYBELLA® permanently destroys fat cells in the treatment area under the chin for an improved profile.
*Multiple injections under the chin per treatment; up to 6 treatments at least 1 month apart.

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INDICATION

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

CONTRAINDICATIONS

KYBELLA® is contraindicated in the presence of infection at the injection sites.

WARNINGS AND PRECAUTIONS

Marginal Mandibular Nerve Injury
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
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, eg, 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.
Injection-Site Hematoma/Bruising
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.
Risk of Injecting Into or in Proximity to Vulnerable Anatomic Structures
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles.

ADVERSE REACTIONS

The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.

Please see KYBELLA® full prescribing information.

References: 1. KYBELLA® Prescribing Information, April 2015. 2. Stryer L. Biosynthesis of membrane lipids and steroids. In: Stryer L, ed. Biochemistry. 4th ed. New York, NY: WH Freeman and Co; 1995:685-712. 3. Rotunda AM. Injectable treatments for adipose tissue: terminology, mechanism, and tissue interaction. Lasers Surg Med. 2009;41(10):714-720.
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