European Union - English - EMA (European Medicines Agency)

serb sa - amifampridine - lambert-eaton myasthenic syndrome - other nervous system drugs - symptomatic treatment of lambert-eaton myasthenic syndrome (lems) in adults.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - amifampridine - tablet - 20mg

Malta - English - Medicines Authority

cherubino limited delf building, sliema road, gzira, gzr 1637, malta - tablet - amifampridine 10 mg - other nervous system drugs

Israel - English - Ministry of Health

medison pharma ltd - amifampridine 10 mg - tablets - amifampridine - symptomatic treatment of lambert-eaton myasthenic syndrome (lems) in adults

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - amifampridine - oral tablet - 20mg

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

sun pharmaceutical industries, inc. - dalfampridine (unii: bh3b64okl9) (dalfampridine - unii:bh3b64okl9) - dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (ms). this was demonstrated by an increase in walking speed [see clinical studies (14)]. the use of dalfampridine extended-release tablets are contraindicated in the following conditions: - history of seizure [see warnings and precautions (5.1)] - moderate or severe renal impairment (crcl ≤ 50 ml/min) [see warnings and precautions (5.2)] - history of hypersensitivity to dalfampridine or 4-aminopyridine; reactions have included anaphylaxis [see warnings and precautions (5.4)] risk summary there are no adequate data on the developmental risk associated with use of dalfampridine in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognize

European Union - English - EMA (European Medicines Agency)

serb sa - amifampridine phosphate - lambert-eaton myasthenic syndrome; paraneoplastic syndromes, nervous system; nervous system neoplasms; paraneoplastic syndromes; nervous system diseases; autoimmune diseases of the nervous system; neurodegenerative diseases; neuromuscular diseases; neuromuscular junction diseases; immune system diseases; autoimmune diseases; autoimmune diseases of the nervous system; cancer; neoplasms - other nervous system drugs - symptomatic treatment of lambert-eaton myasthenic syndrome (lems) in adults.

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

acorda therapeutics, inc. - dalfampridine (unii: bh3b64okl9) (dalfampridine - unii:bh3b64okl9) - dalfampridine 10 mg - ampyra is indicated as a treatment to improve walking in adult patients with multiple sclerosis (ms). this was demonstrated by an increase in walking speed [see clinical studies (14)]. the use of ampyra is contraindicated in the following conditions: - history of seizure [ see warnings and precautions (5.1)] - moderate or severe renal impairment (crcl≤50 ml/min) [see warnings and precautions (5.2) ] - history of hypersensitivity to ampyra or 4-aminopyridine; reactions have included anaphylaxis [see warnings and precautions (5.4) ] risk summary there are no adequate data on the developmental risk associated with use of ampyra in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth 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 dalfampridine to pregnant rats and rabbits throughout organogenesis resulted in no evidence of developmental toxicity in either species. the highest doses tested (10 mg/kg/day in rats, 5 mg/kg/day in rabbits), which were associated with maternal toxicity, are approximately 5 times the mrhd on a body surface area (mg/m 2 ) basis. oral administration of dalfampridine (0, 1, 3, and 9 to 6 mg/kg/day; high dose reduced during the second week of dosing) to female rats throughout pregnancy and lactation resulted in decreased offspring viability at the highest dose tested and decreased body weight in offspring at the mid and high doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (1 mg/kg/day) is less than the mrhd on a mg/m 2 basis. risk summary there are no data on the presence of dalfampridine in human milk, the effects of dalfampridine on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ampyra and any potential adverse effects on the breastfed infant from ampyra or from the underlying maternal condition. safety and effectiveness in patients younger than 18 years of age have not been established. clinical studies of ampyra did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. a population pk analysis showed that dalfampridine clearance modestly decreased with increasing age, but not sufficiently to necessitate a modification of dose with age. other reported clinical experience has identified no differences in responses between the elderly and younger patients. ampyra is known to be substantially excreted by the kidneys and the risk of adverse reactions, including seizures, is greater with increasing exposure of dalfampridine. because elderly patients are more likely to have decreased renal function, it is particularly important to know the estimated creatinine clearance (crcl) in these patients [see warnings and precautions (5.2)]. clearance of dalfampridine is decreased in patients with renal impairment and is significantly correlated with creatinine clearance (crcl) [see clinical pharmacology (12.3)] . ampyra is contraindicated in patients with moderate or severe renal impairment (crcl ≤50 ml/min) [see contraindications (4)]. the risk of seizures in patients with mild renal impairment (crcl 51–80 ml/min) is unknown, but dalfampridine plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures. if unknown, estimated creatinine clearance should be calculated prior to initiating treatment with ampyra [see dosage and administration (2.3) and warnings and precautions (5.2)] .