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KYBELLA™ and (deoxycholic acid) injection is the first and only FDA-approved nonsurgical treatment that contours and improves the appearance of submental fullness, sometimes referred to as “double chin”.

You and your doctor will design a customized treatment plan to help you improve your chin profile. 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™ 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™.

In the pivotal Phase III clinical trials:

  • 68.2% of patients responded to KYBELLA™, compared to 20.5% of patients who responded to placebo, based on validated physician and patient measurements
  • 79% of patients treated with KYBELLA™ reported satisfaction with the appearance of their face and chin
  • After being treated with KYBELLA™, patients reported improvement in self-perception, including feeling happier and younger based on their chin profile, as well as feeling less embarrassed, less self-conscious, less overweight and less bothered by submental fullness
  • KYBELLA™ can cause serious side effects, including trouble swallowing or nerve injury in the jaw that can cause an uneven smile or facial muscle weakness. The most common side effects of KYBELLA™ include: swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area

KYBELLA™ Before & After

KYBELLA™ Frequently Asked Questions

Q. What is submental fullness?

  • Submental fullness, sometimes referred to as “double chin,” is a common, yet undertreated facial aesthetic condition.1 It can detract from an otherwise balanced and harmonious facial appearance2 – leading to an older and heavier look.3
  • Submental fullness can impact a broad range of adults, including both women and men, and can be caused by aging, genetics and weight gain.4
  • 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.5

Q. What is KYBELLA™ (deoxycholic acid) injection?6

  • 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 i
    ndicated 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.

Q. 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.7
  • 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.1
  • 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.

Q. How is KYBELLA™ administered?6

  • Treatment with KYBELLA™ is customized by the physician to the patient’s aesthetic goals for an improved 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.

Q. What are the results of KYBELLA™?6

  • 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.

Q. 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.6
  • 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.

Q. When will KYBELLA™ be available?

KYTHERA has chosen to execute a training-led launch and developed a training program to educate physicians on the safe use of KYBELLA™, and its approved indication. Physician faculty education will begin in June 2015. KYBELLA™ physician training programs will initiate in late summer. Physicians will be able to purchase KYBELLA™ and treat their patients after they have been trained.

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™ should only be administered by a trained healthcare professional.

KYBELLA™ is contraindicated in the presence of infection at the injection sites.

Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage.

Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA™ should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days).

Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA™ in these patients as current or prior history of dysphagia may exacerbate the condition.

In clinical trials, 72% of subjects treated with KYBELLA™ experienced injection site 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.

To avoid the potential of tissue damage, KYBELLA™ should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.

The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.