سعر تيكفيدرا 120مجم 14 كبسولة 2022

Dimethyl fumarate 120 mg gastro-resistant capsules, 14 gastro-resistant capsules, by Biogen; oral disease-modifying therapy for relapsing-remitting multiple sclerosis.

• Relapsing-remitting multiple sclerosis in adults and paediatric patients aged 13 years and olderPopulation: Adults and adolescents ≥13 yearsEuropean Medicines Agency (EPAR product information)

• Most common: flushing (35%) and gastrointestinal events (diarrhoea 14%, nausea 12%, abdominal pain 10%, upper abdominal pain 10%), mostly in the first month.International label, same product · European Medicines Agency (EPAR product information)

• Hypersensitivity to dimethyl fumarate or any excipient.International label, same product · European Medicines Agency (EPAR product information)
• Suspected or confirmed progressive multifocal leukoencephalopathy (PML).International label, same product · European Medicines Agency (EPAR product information)

• Lymphopenia and increased PML risk: do not start with lymphocytes <0.5 × 10^9/L; discontinue if severe lymphopenia persists >6 months.International label, same product · European Medicines Agency (EPAR product information)
• Drug-induced liver injury (ALT/AST ≥3 × ULN with bilirubin ≥2 × ULN) can occur.International label, same product · European Medicines Agency (EPAR product information)
• Renal laboratory changes have been seen; live vaccines might carry increased risk and should not be given.International label, same product · European Medicines Agency (EPAR product information)

• Nephrotoxic medicinal products (e.g. aminoglycosides, diuretics, NSAIDs, lithium)Caution with concurrent nephrotoxic therapy (potential renal adverse reactions).European Medicines Agency (EPAR product information)
• Live vaccinesLive vaccines might carry an increased risk of clinical infection and should not be given during treatment.European Medicines Agency (EPAR product information)

• Registry data (289 prospective outcomes, mostly early exposure) indicate no malformative or foeto/neonatal toxicity; as a precaution avoid in pregnancy and use only if clearly needed.International label, same product · European Medicines Agency (EPAR product information)
• Unknown whether excreted in human milk; decide whether to stop breast-feeding or therapy.International label, same product · European Medicines Agency (EPAR product information)

• Dimethyl fumarate: Mechanism in MS unknown; DMF and its metabolite monomethyl fumarate activate the Nrf2 pathway (cellular response to oxidative stress).