Xcopri (cenobamate) Seizure Treatment: Side Effects, Addiction & Withdrawal

What is Xcopri, and how does it work?

Xcopri is a prescription medicine used to treat partial-onset seizures in adults.

It is not known if
Xcopri is safe and effective in children.

What are the side effects of Xcopri?

Xcopri may cause serious side effects, including:

• problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.
• nervous system problems.
  Xcopri may cause problems that can affect your nervous system. Symptoms of nervous system problems include:
  • dizziness
  • trouble walking or with coordination
  • feeling sleepy and tired
  • trouble concentrating, remembering, and thinking clearly
  • vision problems

The most common side effects of
Xcopri include:

• feeling sleepy and tired
• dizziness
• double vision
• headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of
Xcopri.

For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Does Xcopri cause addiction or withdrawal symptoms?

Drug Abuse And Dependence

Controlled Substance

Xcopri contains cenobamate and is listed as a Schedule V controlled substance.

Abuse

• Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In a human abuse potential study conducted in recreational sedative abusers (n=39), single doses of
  Xcopri (200 mg and 400 mg) were compared to placebo.
• Xcopri at single doses of 400 mg produced responses on positive subjective measures such as “Drug Liking,” “Overall Drug Liking,” “Take Drug Again,” and “Good Drug Effects” that were statistically greater than the responses produced on these measures by placebo.
• In this study, euphoric mood occurred at greater extent with
  Xcopri (400 mg) (8%) than with placebo (0%).
• Phase 1 multiple ascending dose studies in healthy subjects showed rates of euphoria and feeling drunk of about 3% and disturbance in attention of about 5% in subjects who received supratherapeutic doses of cenobamate, but these adverse events were absent in the placebo group.
• In Phase 2 and 3 studies in subjects with epilepsy, euphoric mood, confusional state, and sedation occurred at low rates in subjects who received
  Xcopri (0.5-2.5%).

Dependence

• Physical dependence is a state that develops as a result of physiological
  adaptation in response to repeated drug use, manifested by withdrawal signs and
  symptoms after abrupt discontinuation or a significant dose reduction of a drug.
• Clinical studies in healthy subjects indicate that Xcopri may cause physical
  dependence and lead to a withdrawal syndrome characterized by insomnia,
  decreased appetite, depressed mood, tremor, and amnesia. Xcopri should be
  withdrawn gradually.

What is the dosage for Xcopri?

Important Administration Instructions

• Xcopri may be taken any time with or without food. Swallow tablets whole with liquid.
• Do not crush or chew.

General Dosing Recommendations

Monotherapy And Adjunctive Therapy

• Xcopri is administered orally once daily.
• The recommended dosage and titration,
  which should not be exceeded because of the potential for serious adverse
  reactions, is included in Table 1.

Table 1: Recommended Dosage for Partial-Onset Seizures in Adults

Initial DosageWeek 1 and 212.5 mg once dailyTitration RegimenWeek 3 and 425 mg once dailyWeek 5 and 650 mg once dailyWeek 7 and 8100 mg once dailyWeek 9 and 10150 mg once dailyMaintenance DosageWeek 11 and thereafter200 mg once dailyMaximum DosageIf needed based on clinical response and tolerability, dose may be increased above 200 mg by increments of 50 mg once daily every two weeks to 400 mg.400 mg once daily

Dosage Modifications In Patients With Hepatic Impairment

• For patients with mild to moderate (5-9 points on Child-Pugh assessment) hepatic
  impairment, the maximum recommended dosage is 200 mg once daily.
• Xcopri is not
  recommended for use in patients with severe hepatic impairment.

Discontinuation Of Xcopri

• If Xcopri is discontinued, the dosage should be gradually reduced over a period
  of at least 2 weeks, unless safety concerns require abrupt withdrawal.

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What drugs interact with Xcopri?

Effect Of Xcopri On Other Drugs

Table 5 summarizes the effect of
Xcopri on other drugs.

Table 5: Pharmacokinetic Drug Interactions

Drug or Substrate TypeEffect of
Xcopri on Drug or SubstrateClinical RecommendationAntiepileptic Drugslamotrigine↓ plasma concentrationsBecause of a potential for reduced efficacy of these drugs, increase the dosage of lamotrigine or carbamazepine, as needed, when used concomitantly with
Xcopri.carbamazepine↓ plasma concentrationsphenytoin↑plasma concentrationsBecause of a potential 2-fold increase in phenytoin levels, gradually decrease phenytoin dosage by up to 50% as
Xcopri is being titrated.phenobarbital↑ plasma concentrationsBecause of a potential for an increase in the risk of adverse reactions from these drugs, consider a reduction in dosage of phenobarbital or clobazam, as clinically appropriate, when used concomitantly with
Xcopri.desmethylclobazam, the active metabolite of clobazam↑plasma concentrationsCYP2B6 Substrates↓ plasma concentrationsBecause of a potential for reduced efficacy of these drugs, increase the dosage of CYP2B6 or CYP3 A4 substrates, as needed, when used concomitantly with
Xcopri.CYP3A Substrates↓ plasma concentrationsOral contraceptives↓ plasma concentrationsBecause of the potential for reduced efficacy of oral contraceptives, women should use additional or alternative non-hormonal birth control while taking
Xcopri.CYP2C19 Substrates↑ plasma concentrationsBecause of a potential for an increase in the risk of adverse reactions from these drugs, consider a reduction in dosage of CYP2C19 substrates, as clinically appropriate, when used concomitantly with
Xcopri.

Drug That Shorten The QT Interval

• Xcopri can shorten the QT interval; therefore, caution should be used when
  administering Xcopri and other drugs that shorten the QT interval.

CNS Depressants And Alcohol

• Concomitant use of
  Xcopri with other CNS depressants, including alcohol, may
  increase the risk of neurological adverse reactions, including sedation and
  somnolence.

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Is Xcopri safe to use while pregnant or breastfeeding?

• There are no adequate data on the developmental risk associated with the use of Xcopri in pregnant women.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Xcopri, during pregnancy.
• Encourage women who are taking Xcopri during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.