Belkyra Injectable in Canada is a Health Canada approved safe injectable substance used to reduce and potentially eliminate fat under the chin. This fat under the chin or submental adipose tissue is the target of the Belkyra and the goal is a non-surgical and non-invasive removal of the double chin.
BELKYRA™ Frequently Asked Questions
What is submental fullness?
Submental fullness due to submental fat, sometimes referred to as “a 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, and is not limited to people who are overweight. This condition can impact men or women of average weight and can be caused by aging, genetics, and weight gain. It is often resistant to diet and exercise alone. According to a 2014 survey by the American Society for Dermatologic Surgery (ASDS), over 2/3 of consumers are focusing on the submental fullness, nearly as many as those concerned about the lines and wrinkles around the eyes.
What is BELKYRA™ (deoxycholic acid) injection?
BELKYRA™ (deoxycholic acid) injection, also known as ATX-101, is the first and only FDA and Health Canada approved injectable drug that contours and improves the appearance of submental fullness due to submental fat. BELKYRA™ 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 BELKYRA™ for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
How does BELKYRA™ work?
BELKYRA™ 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, BELKYRA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. After the aesthetic response is achieved, retreatment with BELKYRA™ is not expected. Due to its cytolytic activity, BELKYRA™ should not be injected into, or in close proximity to, vulnerable anatomic structures.
How is BELKYRA™ administered?
BELKYRA™ is administered by injections into the fat under the chin. Each in-clinic treatment session is typically 15-20 minutes. Treatment with BELKYRA™ is customized to the patient’s aesthetic goals for an improved chin profile.
What are the results of BELKYRA™ clinical trials?
In the pooled, pivotal Phase III studies, 68.2 percent of patients responded to BELKYRA™ based on a composite of validated physician and patient measurements. Many patients experienced visible results in two to four treatments. BELKYRA™ treatment resulted in high patient satisfaction. In clinical studies, 28%, 43% and 55% of BELKYRA™-treated patients had a >1-grade composite improvement after two, three, and four treatments, respectively.
Patients also reported improvement in the 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.
Is BELKYRA™ safe?
BELKYRA™ 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 BELKYRA™. Production of BELKYRA™ is a highly controlled, quality-assured, and validated current Good Manufacturing Practices-compliant process to ensure patient safety. BELKYRA™ contains no human or animal-derived substances.
What are the side effects of BELKYRA™?
The safety profile of BELKYRA™ is well characterized. Side effects may include swelling, bruising, pain, numbness, redness, and/or formation of small areas of firmness. Adverse events with BELKYRA™ infrequently resulted in discontinuation from study (1.6% of participants). Care must be taken when injecting BELKYRA™ to avoid the risk of marginal mandibular nerve injury and dysphagia.
When will BELKYRA™ be available?
BELKYRA™ is now available at clinic 805!