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 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®
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) and 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.
Ask your healthcare provider or visit MyKybella.com for full prescribing information.
What to Expect After Treatment?
- For most people, swelling is likely.
- In clinical studies, most reported cases of swelling were mild or moderate and lasted a median of 11 days (range 1-218 days).
- Common treatment-area side effects, including swelling, generally became less severe and happened less often with each following treatment session in clinical studies.
- Consider any upcoming social plans and work commitments following your treatment.
Other possible side effects:
- Sometimes serious side effects can occur, including nerve injury in the jaw (which can cause an uneven smile or facial muscle weakness) or trouble swallowing
- Besides swelling, other common side effects include bruising, pain, numbness, redness, and areas of hardness in the treatment area
Important Safety Information
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses.