سعر اندوداكلاتا 60 مجم 28 قرص 2022

Film-coated tablets containing daclatasvir 60 mg (Al Andalous Pharmaceutical Industries), an HCV NS5A inhibitor; 28 tablets per pack.

• Chronic hepatitis C virus infection, in combination with other medicinal productsPopulation: AdultsEuropean Medicines Agency (EMA)
• Chronic HCV infection in adults, in combination with other antiviral agentsPopulation: AdultsAl Andalous Pharmaceutical Industries (manufacturer website)

• With sofosbuvir, most frequently reported: fatigue, headache and nausea.International label, same formulation · European Medicines Agency (EMA)

• Hypersensitivity to daclatasvir or any excipient.International label, same formulation · European Medicines Agency (EMA)
• Co-administration with strong CYP3A4 and P-gp inducers: phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St John's wort.International label, same formulation · European Medicines Agency (EMA)

• Severe bradycardia and heart block when used with sofosbuvir in patients taking amiodarone; use only if alternatives are not tolerated, with close cardiac monitoring.International label, same formulation · European Medicines Agency (EMA)
• Hepatitis B virus reactivation reported with direct-acting antivirals; screen all patients for HBV before starting.International label, same formulation · European Medicines Agency (EMA)

• Strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir-boosted protease inhibitors)Reduce daclatasvir dose to 30 mg once daily.European Medicines Agency (EMA)
• Moderate CYP3A4 inducers (e.g., efavirenz, etravirine, nevirapine)Increase daclatasvir dose to 90 mg once daily.European Medicines Agency (EMA)
• Amiodarone (with sofosbuvir-containing regimens)Risk of severe bradycardia/heart block; avoid unless no alternative, with close monitoring.European Medicines Agency (EMA)

• Embryotoxic and teratogenic in animals; do not use during pregnancy or in women of childbearing potential not using contraception; continue highly effective contraception for 5 weeks after the last dose.International label, same formulation · European Medicines Agency (EMA)
• Mothers should be instructed not to breast-feed while taking daclatasvir.International label, same formulation · European Medicines Agency (EMA)

• Daclatasvir (salt form not stated): Inhibits HCV non-structural protein 5A (NS5A), an essential component of the viral replication complex, blocking viral RNA replication and virion assembly.