Indications for XCOPRI:
Swallow whole. Initially (Weeks 1 & 2): 12.5mg once daily. Titration regimen (Weeks 3 & 4): 25mg once daily; (Weeks 5 & 6): 50mg once daily; (Weeks 7 & 8): 100mg once daily; (Weeks 9 & 10): 150mg once daily. Maintenance (Week 11 & thereafter): 200mg once daily. Maximum dose (if needed based on response and tolerability, may increase by increments of 50mg/day every 2 weeks): 400mg once daily. Mild to moderate hepatic impairment: max 200mg once daily. Withdraw gradually over ≥2 weeks, if discontinuation needed.
Familial short QT syndrome.
Permanently discontinue if multiorgan hypersensitivity/DRESS occurs. Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes. Monitor for CNS depression, neurological reactions. Avoid abrupt cessation. Drug abuse. Mild to moderate hepatic impairment: see Adults. Severe hepatic impairment: not recommended. Renal impairment. ESRD on dialysis: not recommended. Elderly. Pregnancy. Advise females of reproductive potential to use additional or alternative non-hormonal contraceptive. Nursing mothers.
May antagonize lamotrigine, carbamazepine, oral contraceptives, CYP2B6 and CYP3A substrates. May potentiate phenytoin (reduce phenytoin dose by up to 50%), phenobarbital, clobazam, CYP2C19 substrates. Caution with other drugs that shorten the QT interval. Increased risk of neurological reactions with other CNS depressants, including alcohol.
Somnolence, dizziness, fatigue, diplopia, headache; multiorgan hypersensitivity/DRESS.
Renal (major), fecal. Half-life: 50–60 hours.
Tabs 50mg, 100mg, 150mg, 200mg—30; Blister packs (Titration)—14; (Maintenance)—28