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.
WHAT IS SUBMENTAL FULLNESS?
• Submental fullness, sometimes referred to as “double chin,” is a common, yet undertreated facial aesthetic condition. 1 It can detract from an otherwise balanced and harmonious facial appearance. 2 – leading to an older and heavier look. 3
• Submental fullness can impact a broad range of adults, including both women and men, and can be caused by aging, genetics and weight gain.4
• According to a 2015 survey by the American Society for Dermatologic Surgery (ASDS), over 2/3 of consumers are bothered by submental fullness – nearly as many as those bothered by lines and wrinkles around the eyes.5
WHAT IS KYBELLA® (DEOXYCHOLIC ACID) INJECTION?6
• KYBELLA® (deoxycholic acid) injection, is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness due to submental fat.
• KYBELLA® 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.
• HOW DOES KYBELLA® WORK? • KYBELLA® is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.7
• When injected into subcutaneous fat, 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.1
• To avoid potential tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to the marginal mandibular nerve, salivary glands, lymph nodes and muscles.
WHAT ARE THE RESULTS OF KYBELLA®? 6
• 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.
• Patients also reported improvement in the visual and emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.
• Marginal mandibular nerve (MMN) injury occurred in 4% and dysphagia occurred in 2% of subjects. To avoid potential tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to the MMN, salivary glands, lymph nodes and muscles.
• The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration.
WHAT ARE THE SIDE EFFECTS WITH KYBELLA®?
• The safety profile of KYBELLA® is well-characterized.
• The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration.6
• KYBELLA® is manufactured through a highly-controlled, FDA-regulated process and approved facility to ensure patient safety.
For more information, please see Important Safety Information below.
Important Safety Information
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days). Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and in duration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA® in these patients as current or prior history of dysphagia may exacerbate the condition. In clinical trials, 72% of subjects treated with KYBELLA® experienced injection site 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. To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 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.
For full Prescribing Information, visit mykybella.com.
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REFERENCES: 1. KYTHERA Biopharmaceuticals, Data on File. 2. Swift A, Remington K. BeautiPHIcation: a global approach to facial beauty. Clin Plast Surg. 2011; 38:347-77. 3. Dayan S. Neck rejuvenation. In: Hirsch, Aesthetic Rejuvenation: A Regional Approach. 1st ed. New York, NY: McGraw Hill Professional Publishing; 2008: 123-147. 4. DeFatta R, Ducic Y. Liposuction of the face and neck. Operative Techniques in Otolaryngology. 2007; 18:261- 266. 5. 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?” 6. KYBELLA® Prescribing Information, April 2015. 7. Stryer L, ed. Biochemistry. 4th Edition. New York, NY: WH Freeman and Co.; 2015: 691-707.