KYBELLA® (deoxycholic acid) injection 10 mg/mL
Indication and Important Safety 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.
Injection Site Alopecia
Cases of injection site alopecia have been reported with administration of KYBELLA®. Onset and duration may vary among individuals and may persist.
Consider withholding subsequent treatments until resolution.
Injection Site Ulceration and Necrosis
Injections that are too superficial into the dermis may result in skin ulceration and necrosis. Cases of injection site ulceration and necrosis have been reported
with administration of KYBELLA®. Do not administer KYBELLA® into affected area until complete resolution.
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 accompanying KYBELLA® full Prescribing 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.
Important Safety Information
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 celldeath
(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
Please see accompanying full Prescribing Information, or ask your healthcare
provider, or visit MyKybella.