• Kybella® Questions & Answers

    KYBELLA® is a prescription medicine and is the only FDA-approved injectable treatment used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called “double chin.” The active ingredient in KYBELLA® is synthetic deoxycholic acid. Deoxycholic acid is a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into the fat beneath the chin, KYBELLA® destroys fat cells, resulting in a noticeable reduction in fullness under the chin. Once destroyed, these cells can no longer store or accumulate fat, so further treatment is not expected once you reach your desired aesthetic goal.
    Your specialist will create a tailored treatment plan based on your chin profile. At each treatment, you will be given multiple small injections under your chin. You may receive up to 6 treatment sessions, spaced at least 1 month apart. Many patients experience visible results in 2 to 4 KYBELLA® treatments. 59% of patients received 6 treatments in clinical studies. In clinical studies, results for KYBELLA®-treated patients who had
    • A ≥1-grade composite combined physician- and patient-rated improvement were 8% (1 treatment), 28% (2 treatments), 43% (3 treatments), 55% (4 treatments), 66% (5 treatments) and 72% (6 treatments), compared with 2% (1 treatment), 7% (2 treatments), 12% (3 treatments), 14% (4 treatments), 15% (5 treatments), and 22% (6 treatments) of patients treated with placebo
    • A ≥2-grade composite combined physician- and patient-rated improvement were 0% (1 treatment), 0.2% (2 treatments), 0.8% (3 treatments), 3.5% (4 treatments), 3.9% (5 treatments) and 15% (6 treatments) compared with 0% (1 treatment), 0.2% (2 treatments), 0.2% (3 treatments), 0.5% (4 treatments), 0.2% (5 treatments), and 1.5% (6 treatments) of patients treated with placebo.
    Patients do report pain with injection that typically subsides within 10-15 minutes post-injection. Cold compresses and lidocaine are used to minimize discomfort during treatment. Post-treatment swelling can result in tenderness to the area typically lasting about 1-2 weeks. Cold compresses to the area and lymphatic drainage massage to the area with grape seed oil starting 4-5 days post-treatment can reduce healing time and minimize discomfort.
    Patients typically see results six weeks post-treatment, although some may notice changes sooner. A minimum of two treatments is needed to see best outcomes, some patients may need more than two treatments.
    When injected into fat under the chin, KYBELLA® causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. After reaching your desired aesthetic, further treatment is not expected.
    Cost per vial is $600.
    An average treatment including 2 treatments, six weeks apart is $2400.
    All treatment purchases are nonrefundable. Treatments may be exchanged for store credit towards other products or treatments. Treatment must be received and/or treatment sessions started within one year of purchase.

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    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: bruising, hair loss, open sores (ulcers), damage and tissue cell-death (necrosis) around the injection site. Call your healthcare provider if you develop open sores or drainage 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.
    Please see KYBELLA® full Prescribing Information.
    Please see accompanying full Prescribing Information, or ask your healthcare provider, or visit MyKybella.com.
    KYB1113215  01/18 1804
  • HIGHLIGHTS OF PRESCRIBING INFORMATION