Deoxycholic acid is a naturally occurring molecule that helps break down the fat in the body. The active ingredient in Kybella® is synthetic deoxycholic acid. Fat cells are broken down each time Kybella® is injected into the treatment area beneath the chin. Over a period of time, those cells are cleared away through the natural processes of your body. You are left with a noticeable reduction in fullness under the chin.

We will recommend the number of treatment sessions you may need to achieve your aesthetic goals. The injection process may take 15 to 20 minutes. Each treatment is at least 1 month apart.

Sometimes serious side effects can occur, including:

• Nerve injury in the jaw that can temporarily (median 44 days) cause an uneven smile or facial muscle weakness (experienced by 4 out of 100 people in clinical studies)
• Trouble swallowing (experienced by 2 out of 100 people in clinical studies)
• Possible injection-site problems that include bruising, hair loss, open sores (ulcers), and tissue damage and necrosis around the injection site

The most common side effects include: swelling, numbness, redness, pain, and areas of hardness. Swelling is an expected reaction to treatment, but generally becomes less severe with subsequent treatments.

KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information:

INDICATION

 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

CONTRAINDICATION

S
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
: 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.

Injection-Site Hematoma/Bruising
: 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.

ADVERSE REACTIONS 

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 KYBELLA® full Prescribing Information.