HIGHLIGHTS OF PRESCRIBING INFORMATION ----------------------DOSAGE FORMS AND STRENGTHS-------------------­ These highlights do not include all the information needed to use KYBELLA® safely and effectively. See full prescribing information for • Injection: 10 mg/mL sterile solution, supplied in 2 mL vials. Each vial KYBELLA®. is for single patient use. (3) • Dilution or admixture with other compounds is not recommended. (3) KYBELLA® (deoxycholic acid) injection, for subcutaneous use Initial U.S. Approval: 2015 -----------------------------CONTRAINDICATIONS-----------------------------­ ® ___________________________ _____________________________ KYBELLA is contraindicated in the presence of infection at the injection RECENT MAJOR CHANGES sites. (4) Warning and Precautions (5.5, 5.6) 01/2018 ----------------------WARNINGS AND PRECAUTIONS-----------------------­ --------------------------INDICATIONS AND USAGE---------------------------­ • Marginal mandibular nerve (MMN) injury: Follow injection technique KYBELLA® is a cytolytic drug indicated for improvement in the appearance to avoid this injury. (2.3, 5.1) of moderate to severe convexity or fullness associated with submental fat in • Dysphagia may occur with KYBELLA® use. Use in patients with pre­ adults. (1.1) existing dysphagia may exacerbate the condition. (5.2) • ® ® Submental hematoma/bruising occurs frequently after KYBELLA Limitation of use: The safe and effective use of KYBELLA for the administration. Use with caution in patients who are being treated with treatment of subcutaneous fat outside the submental region has not been antiplatelet or anticoagulant therapy or have coagulation abnormalities. established and is not recommended. (1.2) (5.3) ----------------------DOSAGE AND ADMINISTRATION----------------------­ • Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage. (2.3, 5.4) • 0.2 mL injections spaced 1 cm apart until all sites in the planned • Injection site alopecia: Withhold subsequent treatments until resolution. treatment area have been injected. (2.1) (5.5) • Up to 50 injections or 10 mL may be injected in a single treatment. • Injection site ulceration and necrosis: Do not administer to the affected (2.1) area until complete resolution. (5.6) • Up to 6 single treatments may be administered at intervals no less than 1-month apart. (2.1) -----------------------------ADVERSE REACTIONS------------------------------­ • See General Considerations for Administration and Injection Technique The most common adverse reactions (>20% of subjects) include injection before injection. (2.2, 2.3) 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 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 8 USE IN SPECIFIC POPULATIONS 1.1 Fullness Associated with Submental Fat 8.1 Pregnancy 1.2 Limitation of use 8.2 Lactation 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 2.1 Dosage 8.5 Geriatric Use 2.2 General Considerations for Administration 10 OVERDOSAGE 2.3 Injection Technique 11 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 12 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 12.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics 5.1 Marginal mandibular nerve injury 12.3 Pharmacokinetics 5.2 Dysphagia 13 NONCLINICAL TOXICOLOGY 5.3 Injection site hematoma/bruising 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.4 Risk of injecting in proximity to vulnerable anatomic structures 14 CLINICAL STUDIES 5.5 Injection site alopecia 16 HOW SUPPLIED/STORAGE AND HANDLING 5.6 Injection site ulceration and necrosis 17 PATIENT COUNSELING INFORMATION 6 ADVERSE REACTIONS *Sections or subsections omitted from the full prescribing information are not 6.1 Clinical Trials Experience listed. 6.2 Postmarketing Experience Reference ID: 4208989 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Fullness Associated with Submental Fat KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. 1.2 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. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage KYBELLA® (deoxycholic acid) injection is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm2. • A single treatment consists of up to a maximum of 50 injections, 0.2 mL each (up to a total of 10 mL), spaced 1 cm apart. • Up to 6 single treatments may be administered at intervals no less than 1 month apart. See General Considerations for Administration (2.2) and Injection Technique (2.3) before injection. 2.2 General Considerations for Administration KYBELLA® should be administered by a healthcare professional. Screen patients for other potential causes of submental convexity/fullness (e.g., thyromegaly and cervical lymphadenopathy). Give careful consideration to the use of KYBELLA® in patients with excessive skin laxity, prominent platysmal bands or other conditions for which reduction of submental fat may result in an aesthetically undesirable outcome. Use caution in patients who have had prior surgical or aesthetic treatment of the submental area. Changes in anatomy/landmarks or the presence of scar tissue may impact the ability to safely administer KYBELLA® or to obtain the desired aesthetic result. KYBELLA® is clear, colorless and free of particulate matter. Visually inspect KYBELLA® vials for particulate matter and/or discoloration, and discard the vial if the solution is discolored and/or contains particulate matter. After use, discard any remaining solution in the vial. 2.3 Injection Technique The safe and effective use of KYBELLA® depends on the use of the correct number and locations for injections, proper needle placement, and administration techniques. Health care professionals administering KYBELLA® must understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures [see Warnings and Precautions (5)]. Reference ID: 4208989 Avoid injections near the area of the marginal mandibular nerve [see Warnings and Precautions (5.1)] Needle placement with respect to the mandible is very important as it reduces the potential for injury to the marginal mandibular nerve, a motor branch of the facial nerve. Injury to the nerve presents as an asymmetrical smile due to paresis of lip depressor muscles [see Warnings and Precautions (5.1)]. To avoid injury to the marginal mandibular nerve: • Do not inject above the inferior border of the mandible. • Do not inject within a region defined by a 1-1.5 cm line below the inferior border (from the angle of the mandible to the mentum). • Inject KYBELLA® only within the target submental fat treatment area (see Figures 1 and 3). Figure 1. Avoid the Marginal Mandibular Nerve Area Avoid injection into the platysma Prior to each treatment session, palpate the submental area to ensure sufficient submental fat and to identify subcutaneous fat between the dermis and platysma (pre-platysmal fat) within the target treatment area (Figure 2). The number of injections and the number of treatments should be tailored to the individual patient’s submental fat distribution and treatment goals. Figure 2. Sagittal View of Platysma Area Reference ID: 4208989 Injecting into the treatment area Use of ice/cold packs, topical and/or injectable local anesthesia (e.g., lidocaine) may enhance patient comfort. Outline the planned treatment area with a surgical pen and apply a 1 cm injection grid to mark the injection sites (Figures 2 and 3). Figure 3. Injection Pattern Do not inject KYBELLA® outside the defined parameters [see Warnings and Precautions (5.1, 5.4)]. ® • Using a large bore needle, draw 1 mL of KYBELLA into a sterile 1 mL syringe and expel any air bubbles in the syringe barrel. • Have the patient tense the platysma. Pinch the submental fat and, using a 30 gauge (or ® smaller) 0.5 inch needle, inject 0.2 mL of KYBELLA into the pre-platysmal fat (see Figure 2) next to each of the marked injection sites by advancing the needle perpendicular to the skin. • Injections that are too superficial (into the dermis) may result in skin ulceration and necrosis. Do not withdraw the needle from the subcutaneous fat during injection as this could increase the risk of intradermal exposure and potential skin ulceration and necrosis. ® • Avoid injecting into the post-platysmal fat by injecting KYBELLA into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer (Figure 2). • If at any time resistance is met as the needle is inserted, indicating the possibility of contact with fascial or nonfat tissue, the needle must be withdrawn to an appropriate depth before the injection is administered. • Avoid injecting into other tissues such as the muscle, salivary glands and lymph nodes. • Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied. 3 DOSAGE FORMS AND STRENGTHS Injection: 10 mg/mL. KYBELLA® (deoxycholic acid) injection is a clear, colorless, sterile solution supplied in 2 mL vials