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Epclusa Generic Name & Formulations
Legal Class
Rx
General Description
Sofosbuvir, velpatasvir; 200mg/50mg, 400mg/100mg; tabs.
Pharmacological Class
HCV NS5B polymerase inhibitor + HCV NS5A inhibitor.
See Also
How Supplied
Tabs, pellets—28
Manufacturer
Generic Availability
NO
Epclusa Indications
Indications
Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin (RBV).
Epclusa Dosage and Administration
Adult
Test for HBV infection prior to initiation. 400mg/100mg (tabs) once daily. Treatment-naive/experienced (without cirrhosis or with compensated cirrhosis [Child-Pugh A]): treat for 12 weeks. Treatment-naive/experienced (with decompensated cirrhosis [Child-Pugh B or C]): treat with RBV for 12 weeks. HCV/HIV-1 co-infection: follow same dosage schedule. Liver transplant recipients (without cirrhosis or with compensated cirrhosis [Child-Pugh A]): treat for 12 weeks. Dosing recommendations for RBV in combination therapy: see full labeling.
Children
<3yrs: not established. Test for HBV infection prior to initiation. ≥3yrs (<17kg): 150mg/37.5mg (pellets) once daily; (17–<30kg): 200mg/50mg (tabs or pellets) once daily; (≥30kg): 400mg/100mg (tabs or pellets) once daily. Treatment-naive/experienced (without cirrhosis or with compensated cirrhosis [Child-Pugh A]): treat for 12 weeks. Treatment-naive/experienced (with decompensated cirrhosis [Child-Pugh B or C]): treat with RBV for 12 weeks. HCV/HIV-1 co-infection: follow same dosage schedule. Liver transplant recipients (without cirrhosis or with compensated cirrhosis [Child-Pugh A]): treat for 12 weeks. Dosing recommendations for RBV in combination therapy: see full labeling.
Epclusa Contraindications
Contraindications
When co-administered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy).
Epclusa Boxed Warnings
Boxed Warning
Risk of HBV reactivation in patients coinfected with HCV and HBV.
Epclusa Warnings/Precautions
Warnings/Precautions
Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Increased risk of symptomatic bradycardia when concomitant amiodarone esp. patients also taking beta-blockers or with cardiac comorbidities and/or advanced liver disease. Decompensated cirrhosis: monitor hepatic function. Pregnancy. Nursing mothers.
Epclusa Pharmacokinetics
See Literature
Epclusa Interactions
Interactions
Concomitant amiodarone: not recommended; if no alternatives, monitor cardiac function (see full labeling). Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May potentiate P-gp, BCRP, OATP1B1, OATP1B3, or OATP2B1 substrates. Concomitant P-gp and/or moderate to potent CYP2B6, CYP2C8, CYP3A4 inducers (eg, rifampin, St. John’s wort, carbamazepine), anticonvulsants (eg, phenytoin, phenobarbital, oxcarbazepine), rifabutin, rifapentine, tipranavir/ritonavir, topotecan, efavirenz-containing regimens: not recommended. Separate dosing of antacids by 4hrs. May give H2-antagonists simultaneously or 12hrs apart (comparable to max famotidine 40mg twice daily). Concomitant omeprazole or other PPIs: not recommended; if needed, take Epclusa with food 4hrs before omeprazole 20mg. May potentiate digoxin; monitor. Concomitant tenofovir DF regimens; monitor. May potentiate rosuvastatin (do not exceed 10mg dose) and atorvastatin (monitor). Monitor INR with warfarin.
Epclusa Adverse Reactions
Adverse Reactions
Headache, fatigue; children (<6yrs): also vomiting, product use issue (spitting up drug); with ribavirin: also anemia, nausea, insomnia, diarrhea.
Epclusa Clinical Trials
See Literature
Epclusa Note
Notes
For ribavirin specific dosing and safety information, refer to the full prescribing information.
Epclusa Patient Counseling
See Literature
