Adjunctive treatment of focal-onset seizures w/ or w/o secondary generalisation in adults w/ epilepsy who have not been adequately controlled despite a history of treatment w/ at least 2 anti-epileptic medicinal products.
Adult 12.5 mg daily, titrated gradually to the recommended target dose 200 mg daily. May then be increased to max 400 mg daily based on clinical response. Patient w/ mild, moderate, or severe renal impairment Max: 300 mg daily. Patient w/ mild or moderate hepatic impairment Max: 200 mg daily.
Monitor patients for signs of suicidal ideation & behaviours. Reports of DRESS when cenobamate is started w/ higher doses & titrated rapidly (wkly or faster titration). Risk of dose-dependent shortening of QTcF interval. Contains lactose; not to be taken by patients w/ rare hereditary problems eg, galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Do not use in patients w/ ESRD, patients undergoing haemodialysis or patients w/ severe hepatic impairment. Moderate influence on the ability to drive & use machines; may cause somnolence, dizziness, fatigue, impaired vision & other CNS-related symptoms. Not recommended in women of childbearing potential not using contraception. Women of reproductive potential concomitantly using OCs should practice additional or alternative non-hormonal measures of birth control during treatment & until 4 wk after treatment discontinuation. Do not use during pregnancy unless clinical condition requires. Discontinue breast-feeding during treatment. Dosage selection in elderly patient should be cautious. Safety & efficacy in childn 0 mth to 18 yr have not been established.
Increased risk of neurological adverse reactions w/ other CNS depressants, including alcohol, barbiturates, & benzodiazepines. Increased exposure of phenytoin & phenobarb. Potential increase in exposure of clobazam active metabolite. Dose of cenobamate may need to be increased when co-administered w/ lamotrigine. Potential reduced efficacy of hormonal contraceptives. Reduced exposures of midazolam (CYP3A4 substrate) & bupropion (CYP2B6 substrate). Increased exposure of omeprazole (CYP2C19 substrate). Potential increased exposure of medicinal products transported by OAT3 (eg, baricitinib, cefaclor, empagliflozin, penicillin G, ritobegron, sitagliptin).
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