Multiple sclerosis, relapsing: Treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
藥理
Fumaric Acid Derivative
藥動學
Distribution: Vd: MMF: 53 to 73 L Protein binding: MMF: 27% to 45% Metabolism: Undergoes rapid and extensive presystemic hydrolysis by esterases to its active metabolite, monomethyl fumarate (MMF); MMF is further metabolized via the tricarboxylic acid (TCA) cycle. Major serum metabolites include: MMF, fumaric acid, citric acid, and glucose. Half-life elimination: MMF: ~1 hour Time to peak: 2 to 2.5 hours; delayed to 5.5 hours with food Excretion: CO2 via exhalation (~60%); urine (16%; trace amounts as unchanged MMF), feces (1%)
禁忌症
Known hypersensitivity (eg, anaphylaxis, angioedema) to dimethyl fumarate or any component of the formulation
懷孕分類
nformation related to the use of dimethyl fumarate in pregnancy is limited.
哺乳分類
It is not known if dimethyl fumarate is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
副作用
Cardiovascular: Flushing (40%) Gastrointestinal: Abdominal pain (18%), diarrhea (14%), nausea (12%) Infection: Infection (60%; similar to placebo)
劑量和給藥方法
Multiple sclerosis, relapsing: Oral: Initial: 120 mg twice daily; after 7 days, increase to the maintenance dose: 240 mg twice daily.