Viral infections:
Indications for: EPCLUSA ORAL PELLETS
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).
Adult Dosage:
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 Dosage:
<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 ORAL PELLETS Contraindications:
When co-administered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy).
Boxed Warning:
Risk of HBV reactivation in patients coinfected with HCV and HBV.
EPCLUSA ORAL PELLETS 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.
See Also:
EPCLUSA ORAL PELLETS Classification:
HCV NS5B polymerase inhibitor + HCV NS5A inhibitor.
EPCLUSA ORAL PELLETS 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.
Adverse Reactions:
Headache, fatigue; children (<6yrs): also vomiting, product use issue (spitting up drug); with ribavirin: also anemia, nausea, insomnia, diarrhea.
Note:
For ribavirin specific dosing and safety information, refer to the full prescribing information.
Generic Drug Availability:
NO
How Supplied:
Tabs, pellets—28
