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FREQUENTLY ASKED QUESTIONS

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  • What is submental fullness?
    • Submental fullness due to fat beneath the chin, often referred to as “double chin,” affects a broad range of adults, both women and men1,2
    • It may be due to genetics, weight gain, and/or aging1,2
    • Because aging and genetics can contribute to submental fullness, sometimes diet and exercise alone may not help1-3
    • Submental fullness is a bothersome condition to many potential patients
    • Among the general population, 1 in 4 adults surveyed online was bothered by submental fullness (N = 4000)4,*
    • Excess fat below the chin is one of the top 5 aesthetic concerns among aesthetically oriented patients surveyed online5,†
    • *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

      Online survey of respondents (N = 7315) who were asked, “How bothered are you by excess fat under the chin/neck?”5

  • What is KYBELLA®?
    • 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
  • How does KYBELLA® work?
    • When injected into subcutaneous fat in the treatment area under the chin, KYBELLA® permanently destroys fat cells.6 Once destroyed, those cells cannot store or accumulate fat 
    • Fat cleared from the treatment area is processed through natural metabolic mechanisms7
  • Who is not an appropriate candidate for KYBELLA® treatment?
    • Candidates who may not be appropriate for KYBELLA® treatment are those with excessive skin laxity and prominent platysmal bands6
    • Use caution in patients who have6:
    • A current or prior history of dysphagia
    • Coagulation abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy
    • Had prior surgical or aesthetic procedures in the submental area
    • KYBELLA® is contraindicated in the presence of infection at the injection sites6
  • What are the possible side effects with KYBELLA® injection?
    • 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), and dysphagia (reported in 2% of subjects in the clinical trials)6
    • All cases of marginal mandibular nerve injury and dysphagia resolved spontaneously6
      • Marginal mandibular nerve injury (range: 1-298 days, median: 44 days)6
      • Dysphagia (range: 1-81 days, median: 3 days)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
    • To learn about all side effects associated with KYBELLA®, see the full prescribing information
  • What were the results of KYBELLA® treatment in clinical studies?
    • In pivotal clinical studies:
    • 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:
      • – 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)
    • 16.0% of subjects experienced 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:
      • – 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)
    • 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:
    • Happy
    • Bothered
    • Self-conscious
    • Embarrassed
    • 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.

VIEW

INDIVIDUALLY TAILORED* KYBELLA® INJECTIONS

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.

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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.

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. 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, April 2015. 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.
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