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
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
MECHANISM OF ACTION (MOA)
KYBELLA® is a cytolytic agent
that causes lysis of the
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.
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.
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.
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 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.
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. Care should be taken to avoid inadvertent injection directly into an artery or a vein as it can result in vascular injury.
Injection Site Alopecia
Cases of injection site alopecia have been reported with administration of KYBELLA®. Onset and duration may vary among individuals and may persist. Consider withholding subsequent treatments until resolution.
Injection Site Ulceration and Necrosis
Injections that are too superficial into the dermis may result in skin ulceration and necrosis. Cases of injection site ulceration and necrosis have been reported with administration of KYBELLA®. Do not administer KYBELLA® into affected area until complete resolution.
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.