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Zepatier Generic Name & Formulations
Legal Class
Rx
General Description
Elbasvir, grazoprevir 50mg/100mg; tabs.
Pharmacological Class
HCV NS5A inhibitor + HCV NS3/4A protease inhibitor.
How Supplied
Tabs—28
Manufacturer
Generic Availability
NO
Zepatier Indications
Indications
Chronic HCV genotype 1 or 4 infection with or without ribavirin (RBV).
Zepatier Dosage and Administration
Adult
Test for HBV infection prior to initiation. ≥12yrs or ≥30kg: 1 tab once daily. Genotype 1a: treatment-naive or PegIFN/RBV-experienced without baseline NS5A polymorphisms: treat for 12 weeks; with baseline NS5A polymorphisms: take with RBV for 16 weeks. Genotype 1b: treatment-naive or PegIFN/RBV-experienced: treat for 12 weeks. Genotype 1a or 1b: PegIFN/RBV/HCV NS3/4A protease inhibitor (PI)-experienced: take with RBV for 12 weeks. Genotype 4: treatment-naive: treat for 12 weeks; if PegIFN/RBV-experienced: take with RBV for 16 weeks. HCV/HIV-1 co-infected with or without cirrhosis, renal impairment including hemodialysis: follow same dosage regimen. See full labeling.
Children
<12yrs (<30kg): not established.
Zepatier Contraindications
Contraindications
Moderate or severe hepatic impairment. Prior history of hepatic decompensation due to the risk of hepatic decompensation. Concomitant OATP1B1/3 inhibitors (eg, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, St. John’s wort), efavirenz. When coadministered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy Cat.X).
Zepatier Boxed Warnings
Not Applicable
Zepatier 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. HCV genotype 1a: test for presence of virus with NS5A resistance-associated polymorphisms prior to initiation. Monitor hepatic function prior to initiation, at Week 8, and as clinically indicated; perform additional testing at Week 12 for patients receiving 16 weeks of therapy. Consider discontinuing if ALT persistently >10×ULN. Discontinue if ALT elevation is accompanied with liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR. Risk of hepatic decompensation/failure in those with evidence of advanced liver disease; monitor and discontinue if develops. Liver transplant. Pregnancy. Nursing mothers.
Zepatier Pharmacokinetics
See Literature
Zepatier Interactions
Interactions
See Contraindications. Concomitant moderate CYP3A inducers or certain strong CYP3A inhibitors: not recommended. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May be antagonized by nafcillin, bosentan, etravirine, modafinil. May be potentiated by ketoconazole, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir alafenamide. Potentiates tacrolimus (monitor tacrolimus levels, changes in renal function), atorvastatin (limit max 20mg/day), rosuvastatin (limit max 10mg/day). May potentiate fluvastatin, lovastatin, simvastatin; use lowest effective dose of these drugs. Monitor INR frequently with warfarin.
Zepatier Adverse Reactions
Adverse Reactions
Fatigue, headache, nausea, diarrhea, anemia.
Zepatier Clinical Trials
See Literature
Zepatier Note
Notes
For ribavirin specific dosing and safety information, refer to the full prescribing information.
Zepatier Patient Counseling
See Literature
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