Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - safinamide mesilate, quantity: 65.88 mg (equivalent: safinamide, qty 50 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; colour; hypromellose; macrogol 6000 - xadago is indicated for the treatment of adult patients with fluctuating idiopathic parkinson?s disease (pd) as add-on therapy to a regimen that includes levodopa (l-dopa)

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - safinamide mesilate, quantity: 131.76 mg (equivalent: safinamide, qty 100 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; crospovidone; colour; hypromellose; macrogol 6000 - xadago is indicated for the treatment of adult patients with fluctuating idiopathic parkinson?s disease (pd) as add-on therapy to a regimen that includes levodopa (l-dopa)

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

mdd us operations llc, a subsidiary of supernus pharmaceuticals, inc. - safinamide mesylate (unii: ys90v3dtx0) (safinamide - unii:90enl74sig) - safinamide 50 mg - xadago is indicated as adjunctive treatment to levodopa/carbidopa in patients with parkinson's disease (pd) experiencing "off" episodes. xadago is contraindicated in patients with: - concomitant use of other drugs in the monoamine oxidase inhibitor (maoi) class or other drugs that are potent inhibitors of monoamine oxidase, including linezolid. the combination may result in increased blood pressure, including hypertensive crisis [see warnings and precautions (5.1) and drug interactions (7.1)] . - concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, or tramadol); serotonin-norepinephrine reuptake inhibitors (snris), tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; methylphenidate, amphetamine, and their derivatives; or st john's wort. concomitant use could result in life-threatening serotonin syndrome [see warnings and precautions (5.2) and drug interactions (7.2, 7.3, 7.5)] . - concomitant use of dextromethorphan. the combination of maois and dextromethorphan has been reported to cause episodes of psychosis or abnormal behavior [see drug interactions (7.4)] . - a history of a hypersensitivity to safinamide. reactions have included swelling of the tongue and oral mucosa, and dyspnea. - severe hepatic impairment (child-pugh c: 10-15) [see use in specific populations (8.6)] . risk summary there are no adequate data on the developmental risk associated with the use of xadago in pregnant women. in animals, developmental toxicity, including teratogenic effects, was observed when safinamide was administered during pregnancy at clinically relevant doses. developmental toxicity was observed at doses lower than those used clinically when safinamide was administered during pregnancy in combination with levodopa/carbidopa. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. data animal data in an embryofetal development study in rats, oral administration of safinamide (0, 50, 100, or 150 mg/kg/day) throughout organogenesis resulted in dose-related increases in fetal abnormalities (primarily urogenital malformations) at all doses. a no-effect dose for adverse effects on embryofetal development was not established. the lowest dose tested (50 mg/kg/day) is approximately 5 times the maximum recommended human dose (mrhd) of 100 mg on a body surface area (mg/m 2 ) basis. in a combination embryofetal development study of safinamide and levodopa (ld)/carbidopa (cd) in rats (80/20 mg/kg/day ld/cd in combination with 0, 25, 50, or 100 mg/kg/day safinamide or 100 mg/kg/day safinamide alone), increased incidences of fetal visceral and skeletal malformations and variations were observed at all doses of safinamide in combination with cd/ld and with safinamide alone. the lowest dose of safinamide tested (25 mg/kg/day) is approximately 2 times the mrhd on a mg/m 2 basis. in embryofetal development studies in rabbits, no developmental toxicity was observed at up to the highest oral dose of safinamide tested (100 mg/kg/day). however, when safinamide (0, 4, 12, or 40 mg/kg/day) was administered throughout organogenesis in a combination study of safinamide with ld/cd (80/20 mg/kg/day ld/cd), there was an increased incidence of embryofetal death and cardiac and skeletal malformations, compared to ld/cd alone. a no-effect dose for safinamide was not established; the lowest effect dose of safinamide tested (4 mg/kg/day) is less than the mrhd on a mg/m 2 basis. in a rat pre- and postnatal development study, oral administration of safinamide (0, 4, 12.5, or 37.5 mg/kg/day) throughout pregnancy and lactation resulted in skin discoloration of the offspring, presumed to be due to hepatobiliary toxicity, at the mid and high doses and decreased body weight and increased postnatal mortality in offspring at the highest dose tested. the no-effect dose (4 mg/kg/day) for adverse developmental effects is less than the mrhd on a mg/m 2 basis. risk summary there is no information regarding the presence of xadago or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mothers' clinical need for xadago and any potential adverse effects on the breastfed infant from xadago or from the underlying maternal condition. data animal data skin discoloration, presumed to be caused by hyperbilirubinemia resulting from hepatobiliary toxicity, was observed in rat pups indirectly exposed to safinamide through the milk during the lactation period. safety and effectiveness in pediatric patients have not been established. of the 1516 subjects exposed to xadago in clinical studies, 38% were 65 and over, while 4% were 75 and over. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. xadago plasma concentrations are increased in patients with hepatic impairment [see clinical pharmacology (12.3)] . in patients with moderate hepatic impairment (child-pugh b: 7-9), the maximum recommended dosage of xadago is 50 mg once daily [see dosage and administration (2.2)] . xadago has not been studied in patients with severe hepatic impairment (child-pugh c: 10-15), and is contraindicated in these patients. if patients progress from moderate to severe hepatic impairment, treatment with xadago should be stopped.

Singapore - English - HSA (Health Sciences Authority)

eisai (singapore) pte. ltd. - safinamide mesylate eqv safinamide - tablet, film coated - safinamide mesylate eqv safinamide 50mg

Canada - English - Health Canada

valeo pharma inc - safinamide (safinamide mesylate) - tablet - 50mg - safinamide (safinamide mesylate) 50mg - monoamine oxidase b inhibitors

Canada - English - Health Canada

valeo pharma inc - safinamide (safinamide mesylate) - tablet - 100mg - safinamide (safinamide mesylate) 100mg - monoamine oxidase b inhibitors

Israel - English - Ministry of Health

medison pharma ltd - safinamide as methanesulfonate - film coated tablets - safinamide as methanesulfonate 100 mg - safinamide - xadago is indicated for the treatment of adult patients with idiopathic parkinson’s disease (pd) as add-on therapy to a stable dose of levodopa (l-dopa) alone or in combination with other pd medicinal products in mid-to late-stage fluctuating patients.

Israel - English - Ministry of Health

medison pharma ltd - safinamide as methanesulfonate - film coated tablets - safinamide as methanesulfonate 50 mg - safinamide - xadago is indicated for the treatment of adult patients with idiopathic parkinson’s disease (pd) as add-on therapy to a stable dose of levodopa (l-dopa) alone or in combination with other pd medicinal products in mid-to late-stage fluctuating patients.

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

catalent germany schorndorf gmbh - safinamide mesylate (unii: ys90v3dtx0) (safinamide - unii:90enl74sig) - safinamide 50 mg

European Union - English - EMA (European Medicines Agency)

zambon spa - safinamide methanesulfonate - parkinson disease - anti-parkinson drugs - xadago is indicated for the treatment of adult patients with idiopathic parkinson’s disease (pd) as add-on therapy to a stable dose of levodopa (l-dopa) alone or in combination with other pd medicinal products in mid-to late-stage fluctuating patients.