"HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use KYBELLA � safely and effectively. See full prescribing information for KYBELLA � .
KYBELLA � ( d eoxycholic acid ) injection , for subcutaneous use
Initial U.S. Approval: 2015
RECENT MAJOR CHANGES
Warnings and Precautions (5.5, 5.6) 01/2018
INDICATIONS AND USAGE
KYBELLA� is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. (1.1)
Limitation of use: 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. (1.2)
DOSAGE AND ADMINISTRATION
0.2 mL injections spaced 1 cm apart until all sites in the planned treatment area have been injected. (2.1)
Up to 50 injections or 10 mL may be injected in a single treatment. (2.1)
Up to 6 single treatments may be administered at intervals no less than 1-month apart. (2.1)
See General Considerations for Administration and Injection Technique before injection. (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/mL sterile solution, supplied in 2 mL vials. Each vial is for single patient use. (3)
Dilution or admixture with other compounds is not recommended. (3)
CONTRAINDICATIONS
KYBELLA� is contraindicated in the presence of infection at the injection sites. (4)
WARNINGS AND PRECAUTIONS
Marginal mandibular nerve (MMN) injury: Follow injection technique to avoid this injury. (2.3, 5.1)
Dysphagia may occur with KYBELLA� use. Use in patients with pre-existing dysphagia may exacerbate the condition. (5.2)
Submental hematoma/bruising occurs frequently after KYBELLA� administration. Use with caution in patients who are being treated with antiplatelet or anticoagulant therapy or have coagulation abnormalities. (5.3)
Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage. (2.3, 5.4)
Injection site alopecia: Withhold subsequent treatments until resolution. (5.5)
Injection site ulceration and necrosis: Do not administer to the affected area until complete resolution. (5.6)
ADVERSE REACTIONS
The most common adverse reactions (>20% of subjects) include injection site edema/swelling, hematoma, pain, numbness, erythema and induration. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 1/2018"
