sofosbuvir + velpatasvir


Mylan Healthcare


Concise Prescribing Info
Sofosbuvir 400 mg, velpatasvir 100 mg
Dosage/Direction for Use
Patient w/ genotype 1, 2, 3, 4, 5 or 6 HCV w/ & w/o compensated cirrhosis 1 tab once daily for 12 wk. Patient w/ genotype 1 or 3 HCV w/ decompensated cirrhosis 1 tab once daily in combination w/ ribavirin for 12 wk.
May be taken with or without food: Swallow whole, do not chew/crush.
Hypersensitivity. Concomitant use w/ potent P-gp & CYP inducers eg, rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarb, phenytoin.
Special Precautions
Severe bradycardia & heart block. HCV/HBV co-infection. Patients who have previously failed therapy w/ NS5A-containing regimen. Diabetic patients. Not be administered concurrently w/ other sofosbuvir-containing drugs. Not recommended in co-administration w/ moderate P-gp or CYP inducers eg, oxcarbazepine, modafinil, efavirenz. Concomitant use w/ amiodarone, HIV antiretroviral regimens. Severe renal impairment, ESRD. Child-Pugh-Turcotte class C cirrhosis, liver transplant patients. Not recommended during pregnancy. Not to be used during lactation. Childn & adolescents <18 yr.
Adverse Reactions
Drug Interactions
Decreased plasma conc w/ potent P-gp, CYP2B6, CYP2C8 or CYP3A4 inducers eg, rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarb, phenytoin & moderate P-gp or CYP inducers eg, oxcarbazepine, modafinil, efavirenz, rifapentine. Increased plasma conc w/ P-gp, BCRP, OATP, CYP2B6, CYP2C8 or CYP3A4 inhibitors. Monitor INR values w/ vit K antagonists. Decreased velpatasvir conc w/ antacids, H2-receptor antagonists, PPI, efavirenz/emtricitabine/tenofovir disoproxil fumarate. Severe bradycardia & heart block w/ amiodarone. Increased digoxin, rosuvastatin conc. Increased bleeding risk due to dabigatran etexilate exposure. Increased tenofovir exposure. Monitor statins AR w/ other HMG-CoA reductase inhibitors.
MIMS Class
ATC Classification
J05AP55 - sofosbuvir and velpatasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
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