BEFORE & AFTER
See results of patients treated with KYBELLA® injection. Individual results may vary.
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CLINICAL STUDY DESIGN
Clinical development program1
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.
aEnrolling 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.
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. 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, Necrosis, and Infection
Injections that are too superficial into the dermis may result in skin ulceration and necrosis. Cases of injection site ulceration, necrosis, and infection have been reported with administration of KYBELLA®. Some cases of injection site infection have included cellulitis and abscess requiring antibiotic treatment and incision and drainage. Do not administer KYBELLA® into affected area until complete resolution.
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. Data on file, Allergan, May 2014; NDA 206,333: ATX-101. 2. KYBELLA® Prescribing Information, March 2023. 3. Data on file, Allergan; Integrated Summary of Efficacy: ATX-101.