Kybella

KYBELLA Patient Before and After (Front view)

KYBELLA™ is a prescription medicine used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called “double chin.”

KYBELLA Patient Before and After (Side view)

  • Submental fullness due to submental fat, sometimes referred to as “double chin,” is a common yet undertreated facial aesthetic condition.
  • 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.
  • Treatment with KYBELLA™ is customized by the physician to the patient’s aesthetic goals for an improved chin profile.
  • KYBELLA™ is administered by injections into the fat under the chin. Once the aesthetic response is achieved with KYBELLA™, re-treatment is not expected.
  • Each in-office treatment session is typically 15-20 minutes.
  • KYBELLA™ treatment resulted in high patient satisfaction. 79% of patients treated with KYBELLA™ reported satisfaction with the appearance of their face and chin.

KYBELLA™ Frequently Asked Questions

Can KYBELLA™ be used to eliminate fat in other areas of the body? Is it a potential treatment for obesity or alternative to liposuction?
KYBELLA™ is only 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.

Is KYTHERA seeking other indications or for larger quantities to be injected?
KYTHERA is not currently seeking other indications for KYBELLA™ at this time.

What is the recommended dosage for KYBELLA™?

  • Treatment with KYBELLA™ is customized by the physician to the patient’s aesthetic goals for an improved chin profile. KYBELLA™ is administered by injections into the fat under the chin.
  • In clinical trials, the average dose is approximately 4 to 6 mL delivered in 0.2 mL injections spaced approximately 1 cm apart per treatment session. Each in-office treatment session is typically 15-20 minutes.
  • Many patients experienced visible results in two to four treatments. Up to six treatments may be administered.
    • In clinical studies, 28%, 43% and 55% of KYBELLA™-treated patients had a ≥1-grade composite improvement after 2, 3 and 4 treatments, respectively. 59% of patients received all six treatments.
  • Once the aesthetic response is achieved with KYBELLA™, re-treatment is not expected.

What are the side effects? For example, do patients need to worry about nerve injury?

  • Most adverse reactions were mild or moderate in severity, primarily associated with the treatment area and resolved without intervention. In clinical trials, the incidence and severity of most adverse reactions decreased with subsequent KYBELLA™ treatments.
  • The most common side effects are swelling, bruising, pain, numbness, redness and formation of areas of hardness around the treatment area. Adverse reactions with KYBELLA™ infrequently resulted in discontinuation from study (1.6%).
  • Adverse reactions that lasted more than 30 days and occurred in more than 10% of subjects were injection site numbness (42%), injection site edema/swelling (20%), injection site pain (16%), and injection site induration (13%).
  • 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.

How many injections/treatments does a patient need?

  • The number of injections and the number of treatments should be tailored to the individual patient’s submental fat distribution and treatment goals.
  • In clinical trials, the average dose is approximately 4 to 6 mL delivered in 0.2 mL injections spaced approximately 1 cm apart per treatment session. Each in-office treatment session is typically 15-20 minutes.
  • Many patients experienced visible results in two to four treatments. Up to six treatments may be administered.
    • In clinical studies, 28%, 43% and 55% of KYBELLA™-treated patients had a ≥1-grade composite improvement after 2, 3 and 4 treatments, respectively. 59% of patients received all six treatments.
  • In clinical trials, the volume and corresponding number of injections decreased with each treatment session. Once the aesthetic response is achieved with KYBELLA™, re-treatment is not expected.

How safe is KYBELLA™?

  • The safety profile of KYBELLA™ is well characterized. Side effects may include swelling, bruising, pain, numbness, redness or formation of small areas of firmness. Side effects with KYBELLA™ infrequently resulted in discontinuation from study (1.6% of participants).
  • Most adverse reactions were mild or moderate in severity, primarily associated with the treatment area and resolved without intervention. The percentage of KYBELLA™ adverse reactions reported as mild was 81%, moderate was 17.4% and severe was 1.6%.

Are any long-term safety studies planned?
Yes. Several long-term follow-up studies have already been completed or are ongoing as part of the clinical program and have documented consistent and long-lasting improvements in SMF.

Is KYTHERA planning any post-approval or registry studies?
The majority of patients only need one treatment; however, some may benefit from more than one treatment depending on how much laxity they have and their body’s own biological response to the ultrasound and the collagen-building process. KYTHERA is planning to conduct a prospective, observational, multicenter registry study called CONTOUR to develop a better understanding of the condition of submental fullness, how it is treated in current clinical practice, and risks and benefits associated with its treatment. This registry will involve the systemic collection of data on:

  • The population of physicians with patients who have SMF concerns
  • The population of patients who are eligible for SMF reduction treatment
  • Eligible patients who elect SMF reduction treatment
  • Treatment procedures
  • Treatment outcomes

What is the recovery like with KYBELLA™ compared to liposuction? Can I return to work the same day?

  • To date, there have been no comparative studies between KYBELLA™ and liposuction. For most patients, downtime was minimal and occurred most commonly after the first treatment session. As with other aesthetic treatments, physicians should counsel patients to consider social and work obligations when scheduling treatment.
  • Treatment and response to treatment, including common reactions and downtime, can vary from patient to patient. Patients should discuss their expectations with their physician.

Are there any competitors to KYBELLA™?
KYBELLA™ (deoxycholic acid) injection is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness due to submental fat.

Is this like BOTOX where you need to keep going back for treatment? Will the fat come back in other parts of the body?
To date, there have been no comparative studies between KYBELLA™ and BOTOX. When injected into subcutaneous fat over a single series of treatments (no more than 6), KYBELLA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.

Who is not a good candidate for KYBELLA™?

  • Not all patients are candidates for KYBELLA™. To see if KYBELLA™ is right for you, talk to your doctor or visit www.mykybella.com for more information.
  • Patients with prominent platysmal bands or excessive skin laxity may not achieve ideal results. Use of KYBELLA™ should be avoided in patients who have current or prior history of dysphagia or causes of submental fullness other than submental fat. Caution should be used in patients who have had prior surgical or aesthetic treatment of the submental area. 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.

Will insurance cover it?
No, like most injectables for aesthetic benefit, insurance does not cover KYBELLA™ for the treatment of submental fullness due to submental fat.



Disclaimer: Individual results may vary from patient to patient and there is no guarantee of specific results.

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