Canadá - inglês - Health Canada

marcan pharmaceuticals inc - dimethyl fumarate - capsule (delayed release) - 120mg - dimethyl fumarate 120mg - miscellaneous central nervous system agents

Canadá - inglês - Health Canada

marcan pharmaceuticals inc - dimethyl fumarate - capsule (delayed release) - 240mg - dimethyl fumarate 240mg - miscellaneous central nervous system agents

Canadá - inglês - Health Canada

apotex inc - dimethyl fumarate - capsule (delayed release) - 120mg - dimethyl fumarate 120mg - miscellaneous central nervous system agents

Canadá - inglês - Health Canada

apotex inc - dimethyl fumarate - capsule (delayed release) - 240mg - dimethyl fumarate 240mg - miscellaneous central nervous system agents

Canadá - inglês - Health Canada

teva canada limited - dimethyl fumarate - capsule (delayed release) - 120mg - dimethyl fumarate 120mg - miscellaneous central nervous system agents

Canadá - inglês - Health Canada

teva canada limited - dimethyl fumarate - capsule (delayed release) - 240mg - dimethyl fumarate 240mg - miscellaneous central nervous system agents

Canadá - inglês - Health Canada

auro pharma inc - dimethyl fumarate - capsule (delayed release) - 120mg - dimethyl fumarate 120mg

Canadá - inglês - Health Canada

auro pharma inc - dimethyl fumarate - capsule (delayed release) - 240mg - dimethyl fumarate 240mg

Estados Unidos - inglês - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)]. available data from the tecfidera® pregnancy registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see data) . in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (dmf) was administered during pregnancy and lactation at clinically relevant doses (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. in a prospective observational tecfidera pregnancy registry (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% ci: 1.9-6.1). no specific pattern of major birth defects was identified. important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort. in rats administered dmf orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) was observed at the highest dose tested. this dose also produced evidence of maternal toxicity (reduced body weight). plasma exposure (auc) for monomethyl fumarate (mmf), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (rhd) of 480 mg/day. in rabbits administered dmf orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. the plasma auc for mmf at the no-effect dose is approximately 5 times that in humans at the rhd. oral administration of dmf (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. neurobehavioral impairment was observed at all doses. a no-effect dose for developmental toxicity was not identified. the lowest dose tested was associated with plasma auc for mmf lower than that in humans at the rhd. there are no data on the presence of dmf or mmf in human milk. the effects on the breastfed infant and on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dimethyl fumarate delayed-release capsules and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of dimethyl fumarate delayed-release capsules did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Estados Unidos - inglês - NLM (National Library of Medicine)

msn laboratories private limited - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)]. risk summary there are no adequate data on the developmental risk associated with the use of dimethyl fumarate in pregnant women. in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (dmf) was administered during pregnancy and lactation 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 2-4% and 15-20%, respecti