What is KYBELLA®?

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.” It is not known if KYBELLA® is safe and effective for use outside of the submental area.

Who should not receive KYBELLA®?

You should not receive KYBELLA® if you have an infection in the treatment area.

Before receiving KYBELLA®, tell your healthcare provider about all of your medical conditions, including if you: Have had or plan to have surgery on your face, neck, or chin; have had cosmetic treatments on your face, neck, or chin; have had or have medical conditions in or near the neck area; have had or have trouble swallowing; have bleeding problems; are pregnant or plan to become pregnant (it is not known if KYBELLA® will harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if KYBELLA® passes into your breast milk; talk to your healthcare provider about the best way to feed your baby if you receive KYBELLA®).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take a medicine that prevents the clotting of your blood (antiplatelet or anticoagulant medicine).

What are the possible side effects of KYBELLA®?

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.

The most common side effects of KYBELLA® include: swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.

These are not all of the possible side effects of KYBELLA®. Call your healthcare provider for medical advice about side effects.

Is Kybella Safe?

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.

How does Kybella work?

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.

Is Kybella right for me?

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®.

How many people have been treated with 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®.

Will I experience any side effects?

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.

How many treatments will I need?

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


How long will the results last?

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.

About Submental Fullness

Submental fullness, sometimes referred to as “double chin”, is a common yet undertreated facial aesthetic condition. It can impact a broad range of adults, including both men and women, and can be influenced by several factors such as aging, genetics and weight gain, and is often resistant to diet and exercise alone.1

If you’re bothered by submental fullness, you’re not alone. According to a 2015 survey conducted by the American Society for Dermatologic Surgery (ASDS):

  • 67% of people said they’re bothered by under-the-chin fullness, or double chin
  • People are just as bothered by under-the-chin fullness as they are by lines and wrinkles around and under their eyes

See detailed Important Safety Information here.

What to Expect

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

You and your doctor will design a treatment plan tailored to help you improve your chin profile. During your treatment sessions, your HCP will administer KYBELLA® into the fat under your chin using multiple injections. Many patients experience visible results in 2 to 4 treatment sessions. Up to 6 treatment sessions may be administered spaced no less than one month apart.

Clinical Trial Results for KYBELLA®-Treated Patients

treatments-chart

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 experienced a ≥1-grade improvement with KYBELLA®, compared to 20.5% of patients who responded to placebo, based on validated physician and patient measurements
  • 16% of patients experienced a ≥2-grade improvement with KYBELLA®, compared to 2% 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® 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.” 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.

See detailed Important Safety Information here.

How it Works

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.

You and your doctor will decide how many treatments you need. Once the desired aesthetic response is achieved with KYBELLA®, retreatment is not expected.1

Before receiving KYBELLA®, tell your healthcare provider about all of your medical conditions, including if you: have had or plan to have surgery on your face, neck, or chin; have had cosmetic treatments on your face, neck or chin; have had or have medical conditions in or near the neck area; have had or have trouble swallowing; have bleeding problems; are pregnant or plan to become pregnant (it is not known if KYBELLA® will harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if KYBELLA® passes into your breast milk; talk to your healthcare provider about the best way to feed your baby if you receive KYBELLA®).

See detailed Important Safety Information here.

Results

Pictures speak louder than words.