2 pivotal clinical studies in North America 2,3
Two randomized, multicenter, double-blind, placebo-controlled trials of identical design were conducted. Subjects received up to 6 treatments with
KYBELLA® (N = 514, combined trials) or placebo (N = 508, combined trials) no less than 1 month apart. Subjects ranged in age from 19 to 65 (mean =
49 years), had a BMI ≤ 40 kg/m2 (mean BMI = 29 kg/m2), and represented all Fitzpatrick Skin Types (I-VI). At baseline, 51% of the subjects had a
clinician-rated submental fat severity rating of moderate and 49% had a submental fat rating of severe. Efficacy assessments were based on
≥ 2-grade and ≥ 1-grade improvements in submental convexity or fullness on the composite clinician-reported and subject-reported ratings of
submental fat 12 weeks after final treatment.
Enrolling subjects were between ages 19 and 65 with moderate to severe submental fat. Primary endpoints included ≥ 1 -grade
and ≥ 2 -grade composite reductions on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported
Submental Fat Rating Scale (PR-SMFRS).
bEfficacy endpoints were based on the change from baseline to 12 weeks after the last treatment.
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.
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.