Bothered by the fullness* beneath your chin?
KYBELLA® is the first and only FDA-approved injectable treatment to improve the appearance of moderate to severe fat beneath the chin* by physically destroying fat cells.
The KYBELLA® profile Revealed
“I recently saw a photo of myself in profile and was really frustrated with the fat under my chin. I work out and eat well, but it wouldn’t go away. Then my doctor told me about KYBELLA.®”
If you’re bothered by the fullness beneath your chin, you’re not alone. According to a 2015 survey conducted by the American Society for Dermatologic Surgery, 67% of people said they are bothered by the fat beneath their chin, or what your healthcare provider may refer to as “submental fullness associated with submental fat.”
What causes submental fullness?
Submental fullness due to fat beneath the chin can impact a broad range of both male and female adults. Some possible causes are:
- Weight Gain
Sometimes, even with diet or exercise, the unwanted fullness beneath your chin may not go away, and it could make you appear older or heavier than you actually are. Fortunately, KYBELLA® can help.
How does KYBELLA® work?
When injected into the fat beneath your chin, KYBELLA® destroys fat cells. Once destroyed, those cells cannot store or accumulate fat. 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. Fat cleared from the treatment area is processed through your body’s natural metabolism.
The science Revealed
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.
As part of a clinical development program, KYBELLA® has been evaluated in more than 20 clinical studies. More than 1600 people worldwide have been treated with KYBELLA®.
In clinical studies, 79% of people treated with KYBELLA® had improved satisfaction wit the appearance of the area beneath their chin (compared with 34% of people treated with placebo) 12 weeks after last treatment.
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.
*Fullness associated with submental fat.
How many treatment sessions will I need?
Your healthcare provider will help you determine how many treatment sessions you need based on the amount and distribution of your submental fat and your personal treatment goals. Up to 6 treatments may be administered, spaced no less than 1 month apart.*
*Fifty-nine percent of people treated with KYBELLA® in clinical studies received 6 treatments.
How is KYBELLA® administered?
KYBELLA® is given during an in-office visit. The injection process may take 15 to 20 minutes. Your healthcare provider will give you a series of injections into the fat under your chin at each treatment session.
What can I expect after my treatment session?
For most patients, downtime occurred most commonly after the first treatment session. You should be able to resume your normal daily activities, but are likely to have swelling, so keep your social plans and work commitments in mind when scheduling your treatment. Prior to your treatment session, your healthcare provider may apply ice/cold packs or topical and/or injectable local anesthesia to the treatment area to make you more comfortable. He or she may also suggest you take an over-the-counter pain reliever before your appointment. After treatment, apply ice or a cold pack to the treatment area for 10 to 15 minutes, as needed.
Will there be side effects?
KYBELLA® can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness (experienced by 4 out of 100 people in clinical studies) and trouble swallowing (experienced by 2 out of 100 people in clinical studies). The most common side effects include:
- Areas of hardness
Is KYBELLA® for you?
KYBELLA® may be right for you if:
- You’re bothered by fat under the chin, also known as submental fullness
- You don’t want surgery
- You feel the condition makes you look older or heavier than you actually are
- You eat well and exercise, but submental fullness does not go away
If most of these statements apply to you, ask your doctor if KYBELLA® is right for you. Before receiving treatment, tell your doctor 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); or 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®).
KYBELLA® (deoxycholic acid) injection 10 mg/mL Important 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.
Important Safety Information
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 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.
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.
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
Please see KYBELLA® full Prescribing Information.