سعر اندوهيبسوفير 400 مجم 28 قرص 2022

Tablets containing sofosbuvir 400 mg (Al Andalous Pharmaceutical Industries), an HCV NS5B polymerase inhibitor used in combination regimens; 28 tablets per pack.

• Chronic hepatitis C, in combination with other medicinal productsPopulation: Adults and paediatric patients aged 3 years and olderEuropean Medicines Agency (EMA)
• Chronic HCV infection in adults, in combination with other antiviral agentsPopulation: AdultsAl Andalous Pharmaceutical Industries (manufacturer website)

• With ribavirin (with or without peginterferon), the most common adverse reactions are fatigue, headache, nausea and insomnia; anaemia and neutropenia relate to the ribavirin/peginterferon partners.International label, same formulation · European Medicines Agency (EMA)

• Hypersensitivity to sofosbuvir or any excipient.International label, same formulation · European Medicines Agency (EMA)
• Co-administration with strong intestinal P-gp inducers (rifampicin, rifabutin, St John's wort, carbamazepine, phenobarbital, phenytoin) - markedly reduced sofosbuvir exposure and loss of efficacy.International label, same formulation · European Medicines Agency (EMA)

• Severe bradycardia and heart block with amiodarone when combined with other DAAs; use only if other antiarrhythmics are not tolerated or contraindicated, with close monitoring.International label, same formulation · European Medicines Agency (EMA)
• Hepatitis B virus reactivation, some fatal, reported with direct-acting antivirals; screen all patients for HBV before treatment.International label, same formulation · European Medicines Agency (EMA)
• US boxed warning: risk of hepatitis B virus reactivation in HCV/HBV co-infected patients (fulminant hepatitis, hepatic failure, death); test all patients for HBV before starting and monitor.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• AmiodaroneSevere bradycardia/heart block with sofosbuvir-containing DAA regimens; avoid unless alternatives not possible, with close monitoring.European Medicines Agency (EMA)
• Strong intestinal P-gp inducers (rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, St John's wort)Contraindicated - significantly decrease sofosbuvir plasma concentrations.European Medicines Agency (EMA)
• Moderate P-gp inducers (e.g., oxcarbazepine, modafinil)Expected to decrease sofosbuvir exposure; co-administration not recommended.European Medicines Agency (EMA)

• As a precautionary measure, it is preferable to avoid use during pregnancy. When used with ribavirin, the ribavirin contraindication in pregnancy and contraception requirements apply.International label, same formulation · European Medicines Agency (EMA)
• Should not be used during breast-feeding.International label, same formulation · European Medicines Agency (EMA)

• Sofosbuvir: Pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase; a nucleotide prodrug converted intracellularly to the active uridine analogue triphosphate (GS-461203), which is incorporated into HCV RNA and acts as a chain terminator (EU SmPC).