سعر ايفريسدي 60 مجم per bottle 2026

Powder for oral solution: bottle containing risdiplam 60 mg, constituted to 80 mL of 0.75 mg/mL oral solution (Roche).

• 5q spinal muscular atrophy (SMA type 1, 2 or 3, or 1-4 SMN2 copies)European Medicines Agency (EMA)
• Spinal muscular atrophy (SMA) in pediatric and adult patients (US label)DailyMed (US National Library of Medicine)

• Infantile-onset SMA: pyrexia, rash, diarrhoea most common. Later-onset SMA: pyrexia, headache, diarrhoea, rash; also nausea, mouth ulcers, urinary tract infection, arthralgia; cutaneous vasculitis reported post-marketing.International label, same product · European Medicines Agency (EMA)

• Hypersensitivity to risdiplam or any excipient (EU SmPC). US label: none.International label, same product · European Medicines Agency (EMA), DailyMed (US National Library of Medicine)

• Embryo-foetal toxicity: pregnancy test before treatment; females use effective contraception during and for 1 month after treatment; male patients use contraception during and 4 months after.International label, same product · European Medicines Agency (EMA)
• Possible effects on male fertility; men should not donate sperm during treatment and for 4 months after the last dose.International label, same product · European Medicines Agency (EMA)
• Contains isomalt (hereditary fructose intolerance) and sodium benzoate (may increase jaundice in newborns).International label, same product · European Medicines Agency (EMA)

• MATE1/MATE2-K substrates (e.g. metformin)ModerateRisdiplam inhibits MATE1/MATE2-K in vitro and may increase plasma concentrations of their substrates; avoid co-administration or monitor.European Medicines Agency (EMA), DailyMed (US National Library of Medicine)

• No adequate human data; animal studies showed embryo-foetal toxicity and teratogenicity. Not recommended during pregnancy.International label, same product · European Medicines Agency (EMA), DailyMed (US National Library of Medicine)
• EU SmPC: breast-feeding not recommended during treatment. US label: no human milk data; risdiplam excreted in rat milk.International label, same product · European Medicines Agency (EMA), DailyMed (US National Library of Medicine)

• Risdiplam: Modifies SMN2 pre-mRNA splicing to increase inclusion of exon 7 and production of functional SMN protein.