Most common adverse reactions
(≥10% for XCOPRI and greater than placebo)1*
*Safety information is based on pooled data from Study 1 and Study 2.
- Mood-related adverse events were not common in patients taking XCOPRI® (cenobamate tablets) CV1
- Discontinuation rates due to adverse reactions were 11% (100 mg), 9% (200 mg), and 21% (400 mg) for patients on XCOPRI compared with 4% for placebo1
Drug reaction with eosinophilia and systemic symptom (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 here.
MANAGING ADJUNCTIVE USE OF XCOPRI
WHEN PRESCRIBING XCOPRI
drug load 2
Start low and go slow 1
Consider decreasing dosage
of concomitant AEDs 3*
If a patient experiences adverse events as the XCOPRI® (cenobamate tablets) CV dosage is increased, consider adjusting the dosage of concomitant AEDs.
AEDs where this strategy should be considered include phenytoin, phenobarbital, and clobazam.1
*Pharmacokinetic drug interactions may not necessarily translate into pharmacodynamic observations and clinical responses.4
Please see Section 7 of the Prescribing Information for additional details on drug-drug interactions.
XCOPRI is thought to work via a multimodal mechanism of action1*
XCOPRI has been shown to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents.1
XCOPRI is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.1
*The precise mechanism by which XCOPRI exerts its anticonvulsant activity is unknown.1
References: 1. XCOPRI [package insert]. Paramus, NJ: SK Life Science, Inc. 2. Perucca E, Kwan P. Overtreatment in epilepsy: how it occurs and how it can be avoided. CNS Drugs. 2005;19(11):897-908. 3. St Louis EK. Minimizing the adverse effects of epilepsy therapies: principles and practice. Curr Neuropharmacol. 2009;7(2):106-114. 4. Data on file. SK Life Science, Inc.