MOST COMMON ADVERSE REACTIONS (≥10% FOR XCOPRI AND GREATER THAN PLACEBO)1*
|XCOPRI 400 mg/day|
|XCOPRI 200 mg/day|
|XCOPRI 100 mg/day|
Discontinuation rates due to adverse reactions were 11% (100 mg), 9% (200 mg), and 21% (400 mg) for patients on XCOPRI® (cenobamate tablets) CV compared with 4% for patients on placebo.1
Drug reaction with eosinophilia and systemic symptoms (DRESS), also known as multiorgan sensitivity, has been reported in patients taking antiepileptic drugs, including XCOPRI. DRESS has been reported, including 1 fatality, when XCOPRI is titrated rapidly (weekly or faster titration). No cases of DRESS were reported in an open-label safety study of 1339 epilepsy patients when XCOPRI was initiated at 12.5 mg/day and titrated every 2 weeks. This finding does not establish that the risk of DRESS is prevented by a slower titration; however, XCOPRI should be initiated at 12.5 mg once daily and titrated every 2 weeks.1
This is not a full list of safety information.
For more information, see Full Prescribing Information.
Study 2 was a randomized, double-blind, placebo-controlled study in adult patients with partial-onset seizures with an OLE phase. An analysis of the OLE data evaluated the long-term safety and efficacy (up to 48 months] of adjunctive XCOPRI® (cenobamate tablets) CV. Patients with uncontrolled focal seizures despite concomitant treatment with 1 to 3 ASMs who completed the 18-week double-blind study (n=360) could enter the OLE (n=355), where they underwent a 2-week blinded conversion to a target dosage of XCOPRI 300 mg/day. Doses of concomitant ASMs could be adjusted during the conversion phase. During the OLE treatment phase, concomitant ASMs could be added, removed, or adjusted (no cenobamate monotherapy allowed) and the XCOPRI dosage could be increased or decreased, if clinically indicated, to a minimum of 50 mg/day and a maximum of 400 mg/day. Scheduled OLE assessments occurred every 3 months. Safety assessments included evaluation of treatment-emergent adverse events, including frequency, seriousness, timing, and those leading to discontinuation.
XCOPRI® (cenobamate tablets) CV makes the
concentration of some drugs go up. Consider
decreasing the dosage of clobazam, phenytoin,
and phenobarbital earlier in XCOPRI titration1,2
*Examples include lacosamide, levetiracetam, brivaracetam, perampanel, eslicarbazepine, and topiramate.
FIND MORE INFORMATION FOR PRESCRIBING XCOPRI WITH CONCOMITANT MEDICATIONS