BEFORE & AFTER
See results of patients treated with KYBELLA® injection. Individual results may vary.
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CLINICAL RESULTS
Key findings from the KYBELLA® pivotal clinical trials include:
≥ 1 - GRADE IMPROVEMENT
BEFORE
AFTER
Unretouched photos of clinical trial subject taken before the first treatment session and 12 weeks after the final treatment session.
Sex: F Age: 39 BMI (before/after): 19.7/20.4 Total treatments: 3 Total mLs (all treatment sessions): 12.0
Individual results may vary.
Number of treatments is tailored* to the amount of submental fat and aesthetic goals; 59% of subjects received 6 KYBELLA® treatments in clinical trials.1
*Multiple injections under the chin per treatment; up to 6 treatments at least 1 month apart.1
- 68.2% of subjects treated with KYBELLA® were ≥ 1-grade composite responders,† compared with 20.5% of subjects treated with placebo, based on imputed data with the last observation carried forward2
- Individual trial results: ≥ 1-grade composite responders1
— Trial 1: 70.0% KYBELLA® (N = 256) vs 18.6% placebo (N = 250)
— Trial 2: 66.5% KYBELLA® (N = 258) vs 22.2% placebo (N = 258)
≥ 2 - GRADE IMPROVEMENT
BEFORE
AFTER
Unretouched photos of clinical trial subject taken before the first treatment session and 12 weeks after the final treatment session.
Sex: F Age: 34 BMI (before/after): 24.8/25.0 Total treatments: 6 Total mLs (all treatment sessions): 24.0
Individual results may vary.
Number of treatments is tailored* to the amount of submental fat and aesthetic goals; 59% of subjects received 6 KYBELLA® treatments in clinical trials.1
*Multiple injections under the chin per treatment; up to 6 treatments at least 1 month apart.1
- 16.0% of subjects experienced a ≥ 2-grade composite improvement with KYBELLA®,† compared with 1.5% of subjects treated with placebo, based on imputed data with the last observation carried forward2
- Individual trial results: ≥ 2-grade composite responders1
— Trial 1: 13.4% KYBELLA® (N = 256) vs < 0.1% placebo (N = 250)
— Trial 2: 18.6% KYBELLA® (N = 258) vs 3.0% placebo (N = 258)
In clinical studies, 79% of KYBELLA® subjects had improved satisfaction with the appearance of the area beneath their chin (compared with 34% of subjects treated with placebo) 12 weeks after their last treatment.1,2
IMPROVEMENT IN SELF-PERCEPTION
KYBELLA® subjects also reported greater improvement in the visual and emotional impact of submental fat compared with placebo subjects when asked how they felt in key areas after they received treatment1,2:
- Happy
- Bothered
- Self-conscious
- Embarrassed
- Looking older
- Looking overweight
The most commonly reported adverse reactions in the pivotal clinical trials were injection-site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.1
†Based on validated physician and patient measurements.
Please click here for Important Safety Information.
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. KYBELLA® Prescribing Information, March 2023. 2. Data on file, Allergan; Integrated Summary of Efficacy: ATX-101.