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

micro labs limited - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide tablet is indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. rufinamide tablets are contraindicated in patients with familial short qt syndrome [see warnings and precautions (5.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide tablets, during pregnancy. encourage women who are taking rufinamide tablet during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risks associated with use of rufinamide tablets in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses

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

hikma pharmaceuticals usa inc. - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide is indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. rufinamide is contraindicated in patients with familial short qt syndrome [see warnings and precautions (5.3)] . pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide, during pregnancy. encourage women who are taking rufinamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary: there are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth de

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

glenmark pharmaceuticals inc., usa - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide tablets are indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. rufinamide is contraindicated in patients with familial short qt syndrome [see warnings and precautions (5.3) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide, during pregnancy. encourage women who are taking rufinamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of rufinamide (0, 20, 100, or 300 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal weight and increased incidence of fetal skeletal abnormalities at 100 and 300 mg/kg/day, which were associated with maternal toxicity. the maternal plasma exposure (auc) at the no- adverse effect dose (20 mg/kg/day) for developmental toxicity was less than that in humans at the maximum recommended human dose (mrhd) of 3200 mg/day. oral administration of rufinamide (0, 30, 200, or 1000 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in embryofetal death, decreased fetal body weight, and increased incidence of fetal visceral and skeletal abnormalities at doses of 200 and 1000 mg/kg/day. the high dose (1000 mg/kg/day) was associated with abortion. plasma exposure (auc) at the no-adverse effect dose (30 mg/kg/day) was less than that in humans at the mrhd. when rufinamide was orally administered (0, 5, 30, or 150 mg/kg/day) to pregnant rats throughout pregnancy and lactation, decreased offspring growth and survival were observed at all doses tested. a no-effect dose for adverse effects on pre- and postnatal development was not established. at the lowest dose tested (5 mg/kg/day), plasma exposure (auc) was less than that in humans at the mrhd. risk summary there are no data on the presence of rufinamide in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for rufinamide and any potential adverse effects on the breastfed infant from rufinamide or from the underlying maternal condition. contraception use of rufinamide may reduce the effectiveness of hormonal contraceptives containing ethinyl estradiol or norethindrone. advise women of reproductive potential taking rufinamide who are using a contraceptive containing ethinyl estradiol and norethindrone to use an additional non-hormonal form of contraception [see drug interactions (7.3) and clinical pharmacology (12.3)] . infertility the effect of rufinamide on fertility in humans has not been established. oral administration of rufinamide (20, 60, 200, and 600 mg/kg/day) to male and female rats prior to mating, during mating, and during early gestation (females only) resulted in the impairment of fertility at all dose levels tested. the no-effect dose was not established. the plasma exposure level at 20 mg/kg was approximately 0.2 times the human plasma auc at the mrhd [see nonclinical toxicology ( error! hyperlink reference not valid. )]. safety and effectiveness have been established in pediatric patients 1 to 17 years of age. the effectiveness of rufinamide in pediatric patients 4 years of age and older was based upon an adequate and well-controlled trial of rufinamide that included both adults and pediatric patients, 4 years of age and older, with lennox gastaut syndrome. the effectiveness in patients 1 to less than 4 years was based upon a bridging pharmacokinetic and safety study [see dosage and administration (2.1), adverse reactions ( error! hyperlink reference not valid. ), and clinical studies ( error! hyperlink reference not valid. ) ]. the pharmacokinetics of rufinamide in the pediatric patients, ages 1 to less than 4 years of age is similar to children older than 4 years of age and adults [see clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients below the age of 1 year has not been established. oral administration of rufinamide (0, 15, 50, or 150 mg/kg) to young rats for 10 weeks starting on postnatal day 7 resulted in decreased brain weights at the mid and high doses and neurobehavioral impairment (learning and memory deficit, altered startle response, decreased locomotor activity) and decreased growth (decreased body weight) at the highest dose tested. the no-effect dose for adverse effects on postnatal development in rats (15 mg/kg) was associated with a plasma exposure (auc) lower than that in humans at the maximum recommended human dose (mrhd) of 3200 mg/day. clinical studies of rufinamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. pharmacokinetics of rufinamide in the elderly are similar to that in the young subjects [see clinical pharmacology (12.3) ]. rufinamide pharmacokinetics in patients with severe renal impairment (creatinine clearance < 30 ml/min) was similar to that of healthy subjects. dose adjustment in patients undergoing dialysis should be considered [see clinical pharmacology (12.3) ]. use of rufinamide in patients with severe hepatic impairment (child-pugh score 10 to 15) is not recommended. caution should be exercised in treating patients with mild (child-pugh score 5 to 6) to moderate (child-pugh score 7 to 9) hepatic impairment.

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

hikma pharmaceuticals usa inc. - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide is indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide, during pregnancy. encourage women who are taking rufinamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary: there are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background

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

mylan pharmaceuticals inc. - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide tablets are indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. rufinamide tablets are contraindicated in patients with familial short qt syndrome [see warnings and precautions (5.3)] . there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide, during pregnancy. encourage women who are taking rufinamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. there are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in

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

aurobindo pharma limited - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. rufinamide oral suspension is contraindicated in patients with familial short qt syndrome [see warnings and precautions (5.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide, during pregnancy. encourage women who are taking rufinamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see data] . in the u.s. general population, the estimated bac