Cenobamate
Drug Name:Cenobamate
List Of Brands:
Indication Type Description:
Indication
Indication:
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XCOPRI safely and effectively. See full prescribing information for XCOPRI. XCOPRI® (cenobamate tablets), for oral use, [controlled substance schedule 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)
