KYBELLA

KYBELLA^® (deoxycholic acid) injection is the first and only FDA-approved injectable treatment that is used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called, “double chin.” It is not known if KYBELLA^® is safe and effective in children less than 18 years of age. It is not known if KYBELLA^® is safe and effective for use outside of the submental area.

The active ingredient in KYBELLA^® is deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into the fat beneath your chin, KYBELLA^® causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.

Only you and your doctor can decide if KYBELLA^® is right for you. If you’re bothered by submental fullness, or double chin, ask your doctor about KYBELLA^®.

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^®.

The safety profile of KYBELLA^® is well characterized. The most common side effects are swelling, bruising, pain, numbness, redness and areas of hardness around the treatment area. KYBELLA^® can cause serious side effects, including trouble swallowing and nerve injury in the jaw that can cause an uneven smile or facial muscle weakness.² These are not all of the possible side effects of KYBELLA^®. Call your healthcare provider for medical advice about side effects.

You and your doctor will customize your KYBELLA^® treatment regimen, including how many treatments you need, based on your desired chin profile. Many patients experience visible results in 2 to 4 treatment sessions. During these sessions, your HCP will administer KYBELLA^®into the fat under your chin using multiple injections. Up to 6 treatment sessions may be administered spaced no less than one month apart.

• In clinical studies, results for KYBELLA^®-treated patients who had a ≥1-grade composite improvement were 8% (1 treatment), 28% (2 treatments), 43% (3 treatments), 55% (4 treatments), 66% (5 treatments) and 72% (6 treatments)
• In clinical studies, results for KYBELLA^®-treated patients who had a ≥2-grade composite improvement were 0% (1 treatment), .2% (2 treatments), .8% (3 treatments), 3.5% (4 treatments), 3.9% (5 treatments) and 15% (6 treatments)
• 59% of subjects in the clinical trials received all 6 treatments

When injected into the fat under your chin, 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.