KYBELLA™ is a new treatment option for reducing neck fat below the chin (submental fat), also known as “the double chin.” Such fat deposits are a common aesthetic issue that affects many adults, including men and women. The condition can be influenced by several factors, such as aging, weight gain, or genetics. Many patients find it frustrating that this fat is resistant to changes in diet or exercise.
KYBELLA™is the first FDA-approved nonsurgical treatment option for adults who want to improve the appearance of moderate to severe fat deposits below the chin. The medicine has been studied through over 20 clinical trials, which included more than 2,600 patients from around the world.
The active ingredient, deoxycholic acid, is a naturally occurring molecule in the body, which helps with breaking down and absorbing dietary fats. When injected, the medicine destroys the chin’s fat cells, which prevents this area’s ability to accrue fat. Based on desired results, you and your doctor will create a unique treatment plan that is just right for you. The physician will administer several injections during each visit, which are usually about a month or more apart. Most patients see significant results and improved appearance within two to four clinical visits. Studies show that up to 6 treatments can be administered to the patient. After the desired effects are achieved, no further maintenance treatments are needed.
As with any clinical treatment, side effects do exist. The most common of these include slight swelling, bruising, pain and numbness, redness and hardening in some areas, especially around the injection site. It is important to discuss these possible effects with your physician before beginning treatments. These treatments should always be performed by the highest trained medical professionals, who understand the anatomy of the chin and the makeup of this medication.
Sex: F Age: 35 Weight (before/after): 142.5 lbs/145.5 lbs Total mLs (all treatment sessions): 12 Individual results may vary.
Sex: M Age: 53 Weight (before/after): 192.5 lbs/191.0 lbs Total mLs (all treatment sessions): 16.0 Individual results may vary.
Sex: F Age: 54 Weight (before/after): 153.5 lbs/156.5 lbs Total mLs (all treatment sessions): 15.2 Individual results may vary.
KYBELLA® (deoxycholic acid) injection 10 mg/mL
Indication and Important Safety Information
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.
Contraindications
KYBELLA® is contraindicated in the presence of infection at the injection sites.
Warnings and Precautions
Marginal Mandibular Nerve Injury
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported in 4% of subjects in the clinical trials; all cases resolved spontaneously (range 1-298 days, median 44 days). KYBELLA® should not be injected into or in close proximity to the marginal
mandibular branch of the facial nerve.
Dysphagia
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment may exacerbate the condition.
Injection-Site Hematoma/Bruising
In clinical trials, 72% of subjects treated with KYBELLA® experienced 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.
Risk of Injecting Into or in Proximity to Vulnerable Anatomic Structures
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles.
Adverse Reactions
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
