1 INDICATIONS AND USAGE KYBELLA ® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

Limitations 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.

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 ) Limit ation s 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.

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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.

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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 trials of another drug and may not reflect the rates observed in practice.

In two double-blind, placebo-controlled clinical trials 513 subjects were treated with KYBELLA injection and 506 subjects were treated with placebo.

The population was 19-65 years old, 85% were women, 87% Caucasian, 8% African American.

At baseline the population had a mean BMI of 29 kg/m 2 , moderate to severe submental convexity (graded as 2 or 3 on a 0 to 4 scale) and without excessive skin laxity.

Subjects received up to 6 treatments at least 1 month apart and were followed for up to 6 months after the last received treatment.

The most commonly reported adverse reactions are listed below ( Table 1 ).

Table 1.

Adverse Reactions in the Pooled Trials 1 and 2 a Adverse reactions KYBELLA (N=513) n (%) Placebo (N=506) n (%) Injection site reactions 492 (96%) 411 (81%) edema/swelling 448 (87%) 218 (43%) hematoma/bruising 368 (72%) 353 (70%) pain 356 (70%) 160 (32%) numbness 341 (66%) 29 (6%) erythema 136 (27%) 91 (18%) induration 120 (23%) 13 (3%) paresthesia 70 (14%) 20 (4%) nodule 68 (13%) 14 (3%) pruritus 64 (12%) 30 (6%) skin tightness 24 (5%) 6 (1%) site warmth 22 (4%) 8 (2%) nerve injury b 20 (4 %) 1 (<1%) Headache 41 (8%) 20 (4%) Oropharyngeal pain 15 (3%) 7 (1%) Hypertension 13 (3%) 7 (1%) Nausea 12 (2%) 3 (1%) Dysphagia 10 (2%) 1 (<1%) a Adverse reactions that occurred in ≥ 2% KYBELLA treated subjects and at greater incidence than placebo b Marginal mandibular nerve paresis Other adverse reactions associated with the use of KYBELLA include: injection site hemorrhage, injection site discoloration, pre-syncope/syncope, lymphadenopathy, injection site urticaria, and neck pain.

Adverse reactions that lasted more than 30 days and occurred in more than 10% of subjects were injection site numbness (42%), injection site edema/swelling (20%), injection site pain (16%), and injection site induration (13%).

6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of KYBELLA.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to KYBELLA exposure.

Administration site conditions : injection site ulceration, necrosis, infection, alopecia, scarring, and mass.

Immune System Disorders: Hypersensitivity reactions including rash, urticaria, and itching.

Nervous System Disorders: Oral hypoaesthesia and oral paraesthesia.

Procedural Complications: Vascular injury due to inadvertent intravascular injection.