United States - English - NLM (National Library of Medicine)

sk life science, inc. - cenobamate (unii: p85x70rzws) (cenobamate - unii:p85x70rzws) - xcopri is indicated for the treatment of partial-onset seizures in adult patients. xcopri is contraindicated in patients with: - hypersensitivity to cenobamate or any of the inactive ingredients in xcopri [see warnings and precautions (5.1) and description (11)] - familial short qt syndrome [see warnings and precautions (5.2)] pregnancy exposure registry 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/. risk summary there are no adequate data on the developmental risk associated with the use of xcopri in pregnant women. in animal studies, administration of cenobamate during pregnancy or throughout pregnancy and lactation resulted in adverse effects on development (increased embryofetal mortality, decreased fetal and offspring body weights, neurobehavioral and reproductive impairment in offspring) at clinically relevant drug exposures [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of cenobamate (0, 10, 30, or 60 mg/kg/day) to pregnant rats during the period of organogenesis resulted in increased embryofetal mortality, reduced fetal body weights, and incomplete fetal skeletal ossification at the highest dose tested, which was associated with maternal toxicity. there was a small increase in visceral malformations at the high dose; however, teratogenic potential could not be fully evaluated because of the high rate of embryofetal deaths, which resulted in an inadequate number of fetuses examined. maternal plasma exposure (auc) at the no-effect dose for adverse effects on embryofetal development (30 mg/kg/day) was less than that in humans at the maximum recommended human dose (mrhd) of 400 mg. oral administration of cenobamate (0, 4, 12, or 36 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality at the highest dose tested, which was associated with maternal toxicity. maternal plasma exposure at the no-effect dose (12 mg/kg/day) for adverse effects on embryofetal development was less than that in humans at the mrhd. when cenobamate (0, 11, 22, or 44 mg/kg/day) was orally administered to female rats throughout pregnancy and lactation, neurobehavioral impairment (learning and memory deficit and increased auditory startle response) was observed in the offspring at all doses and decreased preweaning body weight gain and adverse effects on reproductive function (decreased numbers of corpora lutea, implantations, and live fetuses) were seen in the offspring at the high dose. maternal plasma exposure at the lowest effect dose (11 mg/kg/day) for adverse effects on pre- and postnatal development was less than that in humans at the mrhd. risk summary there are no data available on the presence of cenobamate in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. cenobamate was present in rat milk at concentrations similar to those in maternal plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for xcopri and any potential adverse effects on the breastfed infant from xcopri or from the underlying maternal condition. contraception women of reproductive potential concomitantly using oral contraceptives should use additional or alternative non-hormonal birth control [see drug interactions (7.1) and clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients have not been established. juvenile animal toxicity data cenobamate was administered orally to juvenile rats from postnatal day (pnd) 7 to 70. to maintain consistent plasma drug exposures, doses were increased during the dosing period, up to 120 and 80 mg/kg/day in males and females, respectively. adverse effects included mortality, delayed sexual maturation, neurological (decreased grip strength) and neurobehavioral (learning and memory deficits) impairment, decreased sperm count, decreased brain weight, and ocular histopathology. recovery from these effects was observed following discontinuation of dosing. overall, a no-effect dose for adverse effects on postnatal development was not identified. at the lowest doses tested, plasma cenobamate exposures (auc) were less than that in humans at the maximum recommended human dose (mrhd) of 400 mg. clinical studies of xcopri did not include sufficient numbers of patients aged 65 and over to determine the safety and efficacy of xcopri in the elderly population. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . xcopri should be used with caution and dosage reduction may be considered in patients with mild to moderate (clcr 30 to less than 90 ml/min) and severe (clcr less than 30 ml/min) renal impairment. use in patients with end-stage renal disease undergoing dialysis is not recommended [see clinical pharmacology (12.3)] . xcopri should be used with caution and in patients with mild to moderate (5-9 points on child-pugh assessment; class a or b) hepatic impairment. in these patients, the maximum recommended dosage is 200 mg once daily and additional dosage reduction may be considered [see dosage and administration (2.3) and clinical pharmacology (12.3)] . use of xcopri in patients with severe hepatic impairment is not recommended. xcopri contains cenobamate and is listed as a schedule v controlled substance. 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%). 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 [see warnings and precautions (5.5)] .

Canada - English - Health Canada

endo ventures ltd. - cenobamate; cenobamate - kit - 12.5mg; 25mg - cenobamate 12.5mg; cenobamate 25mg

Canada - English - Health Canada

endo ventures ltd. - cenobamate; cenobamate - kit - 100mg; 50mg - cenobamate 100mg; cenobamate 50mg

Canada - English - Health Canada

endo ventures ltd. - cenobamate; cenobamate - kit - 150mg; 200mg - cenobamate 150mg; cenobamate 200mg

Canada - English - Health Canada

endo ventures ltd. - cenobamate; cenobamate - kit - 100mg; 150mg - cenobamate 100mg; cenobamate 150mg

Canada - English - Health Canada

endo ventures ltd. - cenobamate; cenobamate - kit - 150mg; 200mg - cenobamate 150mg; cenobamate 200mg

Israel - English - Ministry of Health

dexcel ltd, israel - cenobamate - film coated tablets - cenobamate 100 mg - cenobamate - xcopri is indicated for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Israel - English - Ministry of Health

dexcel ltd, israel - cenobamate - tablets - cenobamate 12.5 mg - cenobamate - xcopri is indicated for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Israel - English - Ministry of Health

dexcel ltd, israel - cenobamate - film coated tablets - cenobamate 150 mg - cenobamate - xcopri is indicated for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Israel - English - Ministry of Health

dexcel ltd, israel - cenobamate - film coated tablets - cenobamate 200 mg - cenobamate - xcopri is indicated for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.