Submental fullness is an aesthetic condition that may result from the accumulation of subcutaneous fat under the chin. Patients asking about their submental fullness may, at times, refer to it as their “double chin.”
Impacts a broad range of adults, both men and women1,2
Submental fullness may be due to1,2:
Because aging and genetics can contribute to submental fullness, sometimes diet and exercise alone may not help.1-3
Submental fullness is bothersome to many potential patients
1 in 4 adults surveyed online was bothered by submental fullness (N = 4000).4,*
*Online survey of men (51%) and women (49%), ages 18 to 79 years old, who had an annual household income of $50,000 or more.4
The population studied in KYBELLA® clinical trials was 19 to 65 years old.5
Excess fat below the chin is one of the top 5 aesthetic concerns among aesthetically oriented patients surveyed online.6,†
Online survey of respondents (N = 7315) who were asked, “How bothered are you by excess fat under the chin/neck?” Respondents were aesthetically oriented (concerned about their appearance and open to aesthetic treatment).6
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.
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. KYBELLA® Prescribing Information, May 2020. 6. American Society for Dermatologic Surgery (ASDS). 2015 ASDS Consumer Survey on
Cosmetic Dermatologic Procedures. Rolling Meadows, IL: American Society for Dermatologic Surgery (ASDS); 2015.