Kybella®

//Kybella®
Kybella® 2018-01-17T16:47:40+00:00

Both men and women can be affected by submental fullness, also known as “double chin”. Many times, a double chin is caused by weight gain, genetics or just the aging process. The active ingredient in Kybella®, the first and only FDA-approved injectable treatment, is synthetic deoxycholic acid, which is a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into the fat beneath the chin, Kybella® destroys the fat cells, resulting in a noticeable reduction in fullness under the chin. Once destroyed, these cells can no longer store or accumulate fat. Many patients experience visible contouring of their chin profile in two to four treatment sessions spaced at least one month apart. Up to 6 treatments may be administered.

Kybella® Frequently Asked Questions

  • Submental fullness, sometimes referred to as “double chin,” is a common, yet undertreated 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.
  • According to a 2014 survey by the American Society for Dermatologic Surgery (ASDS), over 2/3 of consumers are bothered by submental fullness – nearly as many as those bothered by lines and wrinkles around the eyes.
  • 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 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.
  • 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 reduction of fat cells. Once reduced, those cells cannot store or accumulate fat. After the aesthetic response is achieved, retreatment with Kybella® is not expected.
  • To avoid potential tissue damage, Kybella® should not be injected into or in close proximity (1-1.5 cm) to the marginal mandibular nerve, salivary glands, lymph nodes and muscles.
  • Treatment with Kybella® is customized by the physician to the patient’s aesthetic goals for an changed chin profile.
  • Prior to each treatment session, palpate the submental area to ensure sufficient submental fat.
  • Kybella® is administered by injections into the fat under the chin via 0.2 mL injections spaced 1cm apart using a 30G (or smaller) 0.5-inch needle.
  • The safe and effective use of Kybella® depends on the use of the correct number and locations for injections, proper needle placement and administration techniques.
  • In clinical trials, the average dose administered was approximately 4 to 6 mL per treatment session.
  • Each in-office treatment session is typically 15-20 minutes.
  • In clinical trials, many patients experienced visible results in two to four treatment sessions spaced at least one month apart. Up to 6 treatments may be administered – 59% of subjects received 6 treatments.
  • 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.
  • 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.
  • 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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