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Approved Use and
Important Safety Information

What is KYBELLA® (deoxycholic acid) injection 10 mg/mL?

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 or in children less than 18 years of age.

Who should not receive KYBELLA®?

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

 

Approved Use and Important Safety Information

What is KYBELLA® (deoxycholic acid) injection 10 mg/mL ?

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 or in children less than 18 years of age.

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 nerve injury in the jaw (which can cause an uneven smile or facial muscle weakness), or trouble swallowing.

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.

Please see KYBELLA® full Prescribing Information.

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