KYBELLA® is an individually tailored injectable treatment that permanently destroys fat cells in the treatment area under the chin for an improved profile.6 KYBELLA® is intended for adults with moderate to severe submental fat (double chin)6
Multiple injections are given under the chin per treatment; up to 6 treatments may be given, at least 1 month apart6
The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended6
KYBELLA® can cause serious side effects, including marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (reported in 4% of subjects in the clinical trials), dysphagia (reported in 2% of subjects in the clinical trials), injection-site hematoma/bruising, alopecia, ulceration and necrosis6
All cases of marginal mandibular nerve injury and dysphagia resolved spontaneously6
Injection-site ulceration, necrosis, and alopecia are adverse reactions identified during postapproval use of KYBELLA®6
The most common adverse reactions with KYBELLA® were primarily associated with the treatment area: edema/swelling (87%), hematoma/bruising (72%), pain (70%), numbness (66%), erythema (27%), and induration (23%)6
Although patients are likely to have swelling, most of the swelling was mild or moderate in clinical studies and lasted a median of 11 days (range: 1-218 days)6,8
The incidence and severity of most adverse reactions, including swelling, decreased with subsequent treatments in clinical studies8
68.2% of subjects treated with KYBELLA® experienced a ≥ 1-grade composite improvement,* compared with 20.5% of subjects treated with placebo, based on imputed data with the last observation carried forward9
Individual trial results for ≥ 1-grade composite responders were as follows6:
16.0% of subjectsexperienced a ≥ 2-grade composite improvement with KYBELLA®,* compared with 1.5% of subjects who were treated with placebo, based on imputed data with the last observation carried forward9
Individual trial results for ≥ 2-grade composite responders were as follows6:
Patient satisfaction: In clinical studies, 79% of subjects treated with KYBELLA® 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 6,9
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 treatment6,9:
— Looking older
— Looking overweight
*Based on validated physician and patient measurements.
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.
References: 1. Rzany B, Griffiths T, Walker P, Lippert S, McDiarmid J, Havlickova B. Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic
injectable treatment: results from a phase III, randomized, placebo-controlled study. Br J Dermatol. 2014;170(2):445-453. 2. DeFatta R, Ducic Y. Liposuction of the face and neck.
Oper Tech Otolaryngol. 2007;18(3):261-266. 3. Schlessinger J, Weiss SR, Jewell M, et al. Perceptions and practices in submental fat treatment: a survey of physicians and patients. Skinmed. 2013;11(1):27-31. 4. Data on file, Allergan, February
2016; KYBELLA® Key Market Metrics and Bridge Study. 5. American Society for Dermatologic Surgery (ASDS). 2015 ASDS Consumer Survey on
Cosmetic Dermatologic Procedures. Rolling Meadows, IL: American Society for Dermatologic Surgery (ASDS); 2015. 6. KYBELLA® Prescribing Information, January 2018. 7. Rotunda AM. Injectable treatments for adipose tissue: terminology, mechanism, and tissue interaction. Lasers Surg Med. 2009:41(10):714-720. 8. Data on file, Allergan; Integrated Summary of Safety: ATX-101. 9. Data on file, Allergan; Integrated Summary of Efficacy: ATX-101.