KYBELLA

1 2 .3 Phar m a c o k in et i cs Endogenous deoxycholic acid plasma levels are highly variable within and between individuals; most of this natural bile component is sequestered in the enterohepatic circulation loop. Absorption and

DistributionDeoxycholic acid from KYBELLA is rapidly absorbed following subcutaneous injection. After dosing with the maximum recommended single treatment dose with KYBELLA (100 mg), maximum plasma concentrations (mean C max ) were observed with a median T max of 18 ...

Two randomized, multi-center, double-blind, placebo-controlled trials of identical design were conducted to evaluate KYBELLA injection for use in improvement in the appearance of convexity or fullness associated with submental fat. The trials enrolled healthy adults (ages 19 to 65, BMI ≤ 40 kg/m 2 ) with moderate or severe convexity or fullness associated with submental fat (i.e., grade 2 or 3 on 5-point grading scales, where 0 = none and 4 = extreme), as judged by both clinician and subject ratings. Subjects received up to 6 treatments with KYBELLA (N=514, combined trials) or placebo (N=508, ...

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. 6 . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical...

KYBELLA injection is contraindicated in the presence of infection at the injection sites. KYBELLA is contraindicated: In the presence of infection at the injection sites . ( 4 )

5 WARNINGS AND PR E CAUTIONS 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 vul...