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WHAT IS KYBELLA®?
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ABOUT SUBMENTAL FULLNESS
Do you have some extra fullness beneath your chin? Maybe it's something you've had your whole life, something that developed over the years, or something you noticed recently. This is a condition called submental fullness, which some people refer to as “double chin."
WHAT CAUSES SUBMENTAL FULLNESS?
Both men and women may be affected by submental fullness, which can be caused by:
WEIGHT GAIN
GENETICS
AGING
You don't have to be overweight to have fullness under your chin. And sometimes, no matter how much you exercise or diet, the condition may not go away.
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 SURVEYED SAID THEY ARE BOTHERED BY THE FAT BENEATH THEIR CHIN*
In fact, the survey results showed that people are just as bothered by submental fullness as they are by lines and wrinkles around and under their eyes.*
KYBELLA® MAY HELP IMPROVE YOUR CHIN PROFILE
If you’re interested in a nonsurgical way to reduce submental fullness, also known as double chin, KYBELLA® may be right for you. KYBELLA® is a first-of-its-kind injectable treatment for adults with submental fullness that destroys fat cells under the chin to improve your profile.
* American Society for Dermatologic Surgery 2015 Consumer Survey on Cosmetic Dermatologic Procedures (N=7,315); Exact survey language was, “How bothered are you by excess fat under the chin/neck?” 69% of people responded they were bothered to the question: “How bothered are you by lines/wrinkles around/under the eyes?”
VISIBLE RESULTS
IN 2-4 TREATMENTS
MANY PATIENTS EXPERIENCE VISIBLE RESULTS AFTER 2 TO 4 TREATMENTS. 59% OF PATIENTS RECEIVED 6 TREATMENTS IN CLINICAL TRIALS.
COMBINED PHYSICIAN AND PATIENT RATING FOR LEVEL OF IMPROVEMENT
12 WEEKS AFTER FINAL TREATMENT
| TRIAL 1 | TRIAL 2 | |||
|---|---|---|---|---|
| ENDPOINT | KYBELLA® (N = 256) | PLACEBO (N = 250) | KYBELLA® (N = 258) | PLACEBO (N = 258) |
| Significant/ a great deal better (2-grade composite response)a | 13.4% | <0.01% | 18.6% | 3.0% |
| Some/ moderately better (1-grade composite response)b | 70% | 18.6% | 66.5% | 22.2% |
| TREATMENT DETAILS | AFTER 1 TREATMENT | AFTER 2 TREATMENTS | AFTER 3 TREATMENTS | AFTER 4 TREATMENTS | AFTER 5 TREATMENTS | AFTER 6 TREATMENTS | |
|---|---|---|---|---|---|---|---|
| Percentage of patients who experienced some improvement (moderately better) | KYBELLA | 8% | 28% | 43% | 55% | 66% | 72% |
| PLACEBO | 2% | 7% | 12% | 14% | 15% | 22% | |
| Percentage of patients who experienced significant improvement (a great deal better) | KYBELLA | 0% | 0% | 1% | 4% | 4% | 15% |
| PLACEBO | 0% | 0% | 0% | 1% | 0% | 2% | |
a At least 2-grade reduction on both the clinician-reported and patient-reported ratings of submental fat.
b At least 1-grade reduction on both the clinician-reported and patient-reported ratings of submental fat.
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BEFORE + AFTER
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REAL STORIES
APPROVED USE AND IMPORTANT SAFETY INFORMATION
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 the treatment of fat outside of the submental area or in children under 18 years of age.
Who should not receive KYBELLA®?
Do 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).
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:
- Nerve injury in the jaw (which can cause an uneven smile or facial muscle weakness)
- Trouble swallowing
- Injection site problems, including a collection of blood under the skin (hematoma) or bruising, damage to an artery or vein if KYBELLA® is inadvertently injected into it, hair loss, open sores (ulcers), damage and tissue cell-death (necrosis) around the injection site, infection. Call your healthcare provider if you begin to develop weakness in the muscles of your face or your smile becomes uneven; have difficulty swallowing, or if any of the symptoms that you already have get worse; develop redness, pain, open sores, or drainage at or from the treatment area
The most common side effects of KYBELLA® include swelling, pain, numbness, redness, and areas of hardness in the treatment area.
These are not all of the possible side effects of KYBELLA®. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/safety/MedWatch or call 1-800-FDA-1088.
Please see KYBELLA® full Prescribing Information.
Please see accompanying full Prescribing Information, or ask your healthcare provider, or visit MyKybella.com.