Type:Tablet
Generic Name:Daclatasvir
Manufacturer:Incepta Pharmaceuticals Ltd.
Price:৳400.00
Chronic hepatitis C virus infection in adults.
May be taken with or without food.
Hepatitis C Indicated for use with sofosbuvir for chronic hepatitis C virus (HCV) genotypes 1 and 3 infection Genotype 1 Without cirrhosis or with compensated (Child-Pugh A) cirrhosis: 60 mg (plus sofosbuvir 400 mg) PO qDay for 12 weeks Decompensated (Child-Pugh B or C) cirrhosis or posttransplant: 60 mg (plus sofosbuvir 400 mg) PO qDay plus ribavirin for 12 weeks Genotype 3 Without cirrhosis: 60 mg (plus sofosbuvir 400 mg) PO qDay for 12 weeks Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis, or posttransplant: 60 mg (plus sofosbuvir 400 mg) PO qDay plus ribavirin for 12 weeks Hepatic impairment (any degree): No dose adjustment required
Renal impairment (any degree): No dose adjustment required
Hypersensitivity. Co-administration w/ strong CYP3A4 inducers & P-gp eg phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort.
Inhibits NS5A, a nonstructural protein encoded by HCV. Binds to the N-terminus within domain 1 of NS5A, which may cause structural distortions that interfere with NS5A functions, and thereby inhibits both viral RNA replication and virion assembly.
Patients w/ genotype 1 infection & compensated cirrhosis; receiving amiodarone; decompensated liver disease; prior exposure to a NS5A inhibitor; pre-, peri- or post-liver transplant or other organ transplant; HIV/HCV, HBV co-infected patients. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Women of childbearing potential. Pregnancy & lactation. Childn & adolescents <18 yr. Lactation Unknown if distributed in human breast milk
>10% Headache (14%),Fatigue (14%) 1-10% Nausea (8%),Diarrhea (5%),Elevated lipase, >3 x ULN (2%)
Pregnancy No data in pregnant women are available If daclatasvir and sofosbuvir are administered with ribavirin, the warnings and precautions for ribavirin, in particular the pregnancy avoidance warning, apply to this combination regimen (see ribavirin prescribing information) Lactation Unknown if distributed in human breast milk The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
May lead to lower exposure & loss of efficacy w/ phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone & St. John's wort. Decreased plasma levels & therapeutic effect w/ strong or moderate CYP3A4 & P-gp inducers. Increased plasma levels w/ strong CYP3A4 inhibitors. May increase systemic exposure of P-gp, OATP, 1B1, OCT1 or BCRP substrates. Boceprevir, telaprevir, atazanavir/ritonavir, efavirenz, cobicistat-containing, clarithromycin, telithromycin, erythromycin, dabigatran, etexilate, posaconazole, voriconazole, amiodarone, digoxin, Ca channel blockers, HMG-CoA reductase inhibitors.
