KYBELLA FAQ

KYBELLA™ FREQUENTLY ASKED QUESTIONS

WHAT IS SUBMENTAL FULLNESS?

• Submental fullness, sometimes referred to as “double chin,” is a common, yet under-treated facial aesthetic condition. It can detract from an otherwise balanced and harmonious facial appearance – leading to an older and heavier look.
• Submental fullness can impact a broad range of adults, including both women and men, and can be caused by aging, genetics and weight gain.

WHAT IS KYBELLA™ (DEOXYCHOLIC ACID) INJECTION?

• KYBELLA™ (deoxycholic acid) injection, also known as ATX-101, is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness due to submental fat.
• KYBELLA™ is indicated for improvement in the appearance of moderate to severe fullness associated with submental fat in adults.

HOW DOES KYBELLA™ WORK?

• KYBELLA™ is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.
• When injected into subcutaneous fat, KYBELLA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. After the aesthetic response is achieved, retreatment with KYBELLA™ is not expected.
• The fat pocket under the chin is treated with injections to the area using a very fine needle. The procedure takes approximately 15-20 minutes, and a second treatment approximately one to two months afterward is typically recommended for maximum results.

WHAT ARE THE RESULTS OF KYBELLA™?

• 68.2% of subjects treated with KYBELLA™ were responders compared to 20.5% of placebo-treated subjects, based upon validated physician and patient measurements.*
• KYBELLA™ treatment resulted in high patient satisfaction – 79% of KYBELLA™-treated patients reported satisfaction with their appearance in association with their face and chin.
• Patients also reported improvement in the visual and emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.

WHAT ARE THE SIDE EFFECTS WITH KYBELLA™?

• The safety profile of KYBELLA™ is well-characterized.
• KYBELLA™ has been the focus of a global clinical development program involving over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA™.
• KYBELLA™ is manufactured through a highly-controlled, FDA-regulated process and approved facility to ensure patient safety.
• The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration.
• Marginal mandibular nerve (MMN) injury occurred in 4% and dysphagia occurred in 2% of subjects. To avoid potential tissue damage, KYBELLA™ should not be injected into or in close proximity (1-1.5 cm) to the MMN, salivary glands, lymph nodes and muscles.

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