Bottles; 30 count Strength NDC Number Tablet Description (Color, Shape, Markings) 50 mg 71699-050-30 Film coated round yellow tablets with SK on one side and 50 on the other side 100 mg 71699-100-30 Film coated round brown tablets with SK on one side and 100 on the other side 150 mg 71699-150-30 Film coated round light orange tablets with SK on one side and 150 on the other side 200 mg 71699-200-30 Film coated modified oval light orange tablets with SK on one side and 200 on the other side HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use XCOPRIsafely and effectively. See full prescribing information for XCOPRI.XCOPRI� (cenobamate tablets), for oral use, [controlled substanceschedule pending] Initial U.S. Approval: XXXX [pending controlled substance scheduling]INDICATIONS AND USAGE XCOPRI is indicated for the treatment of partial-onset seizures in adult patients. (1) DOSAGE AND ADMINISTRATION ______________ �Swallow tablets whole. Do not crush or chew. (2.1) �The recommended initial dosage of XCOPRI is 12.5 mg once daily, titrated to the recommended maintenance dosage of 200 mg once daily. The recommended titration schedule should not be exceeded. The maximum dosage is 400 mg once daily. (2.2) �Hepatic impairment: For patients with mild or moderate hepatic impairment, the maximum recommended dosage is 200 mg once daily. (2.3, 8.7, 12.3) DOSAGE FORMS AND STRENGTHS �Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. (3) CONTRAINDICATIONS �Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI. (4) �Familial Short QT syndrome. (4) WARNINGS AND PRECAUTIONS �Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology. (5.1) �QT Shortening: Use caution when administering XCOPRI with other drugs that shorten the QT interval (5.2) �Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation. (5.3) �Neurological Adverse Reactions: Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on XCOPRI. Concomitant use with other CNS depressants or alcohol may have additive effects. (5.4) �Withdrawal of Antiepileptic Drugs: XCOPRI should be gradually withdrawn to minimize the potential of increased seizure frequency. (5.5) ADVERSE REACTIONS The most common adverse reactions in patients receiving XCOPRI (at least 10% for XCOPRI and more frequently than placebo) include somnolence, dizziness, fatigue, diplopia, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact SK Life Science, Inc. at 1-866-657-5574 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ___________________ DRUG INTERACTIONS____________________ �Phenytoin: Gradually decrease phenytoin dosage by up to 50% (7.1) �Phenobarbital and Clobazam: Reduce dosage as needed when used concomitantly with XCOPRI. (7.1) �Lamotrigine, Carbamazepine: Increase dosage as needed when used concomitantly with XCOPRI. (7.1) �CYP2B6 and CYP3A Substrates: Increase dosage as needed when used concomitantly with XCOPRI. (7.1) �CYP2C19 Substrates: Reduce dosage as needed when used concomitantly with XCOPRI. (7.1) �Oral Contraceptives: Effectiveness of hormonal oral contraceptives may be reduced when administered concomitantly with XCOPRI. Women should use additional or alternative non-hormonal birth control. (7.1) USE IN SPECIFIC POPULATIONS �Pregnancy: Based on animal data, may cause fetal harm. (8.1) �Renal Impairment: Use with caution and dosage reduction may be considered in patients with mild to moderate (CLcr 30 to < 90 mL/min) and severe (CLcr < 30 mL/min) renal impairment. Use not recommended in end-stage renal disease (CLcr < 15 mL/min) undergoing dialysis. (8.6) �Hepatic Impairment: Use with caution in patients with mild to moderate hepatic impairment; lower maximum dosage and additional dosage reduction may be considered. Use of XCOPRI in patients with severe hepatic impairment is not recommended. (2.3, 8.7) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 11/2019