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)

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0.2 mL injections spaced 1 cm apart until all sites in the planned treatment area have been injected. ( 2.1)

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Up to 50 injections or 10 mL may be injected in a single treatment. ( 2.1)

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Up to 6 single treatments may be administered at intervals no less than 1‑month apart. ( 2.1)

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See General Considerations for Administration and Injection Technique before injection. ( 2.2, 2.3)

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Injection: 10 mg/mL sterile solution, supplied in 2 mL vials. Each vial is for single patient use. ( 3)

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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

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Marginal mandibular nerve (MMN) injury: Follow injection technique to avoid this injury. ( 2.3, 5.1)

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Dysphagia may occur with KYBELLA use. Use in patients with pre-existing dysphagia may exacerbate the condition. ( 5.2)

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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)

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Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage. ( 2.3, 5.4)

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 Kythera Biopharmaceuticals, Inc. at 1-844-KYTHERA (1-844-598-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.