These highlights do not include all the information needed to use ZEPATIER safely and effectively. See full prescribing information for ZEPATIER.
ZEPATIER™ (elbasvir and grazoprevir) tablets, for oral use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults. (1)
DOSAGE AND ADMINISTRATION
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Testing prior to initiation:
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Genotype 1a: Testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended. (2.1)
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Obtain hepatic laboratory testing. (2.1)
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Recommended dosage: One tablet taken orally once daily with or without food. (2.2)
Dosage Regimens and Durations for ZEPATIER in Patients with Genotype 1 or 4 HCV with or without Cirrhosis
|
Patient Population |
Treatment |
Duration |
|
|
Genotype 1a:
Treatment-naïve or PegIFN/RBV-experienced* without baseline NS5A polymorphisms† |
ZEPATIER |
12 weeks |
Genotype 1a:
Treatment-naïve or PegIFN/RBV-experienced* with baseline NS5A polymorphisms† |
ZEPATIER + ribavirin |
16 weeks |
Genotype 1b:
Treatment-naïve or PegIFN/RBV-experienced* |
ZEPATIER |
12 weeks |
|
Genotype 1a or 1b: PegIFN/RBV/PI-experienced‡ |
ZEPATIER + ribavirin |
12 weeks |
Genotype 4:
Treatment-naïve |
ZEPATIER |
12 weeks |
Genotype 4:
PegIFN/RBV-experienced* |
ZEPATIER + ribavirin |
16 weeks |
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HCV/HIV-1 co-infection: Follow the dosage recommendations in the table above. (2.2)
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Renal Impairment, including hemodialysis: No dosage adjustment of ZEPATIER is recommended. Refer to ribavirin prescribing information for ribavirin dosing and dosage modifications. (2.3)
DOSAGE FORMS AND STRENGTHS
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Tablets: 50 mg elbasvir and 100 mg grazoprevir (3)
CONTRAINDICATIONS
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Patients with moderate or severe hepatic impairment (Child-Pugh B or C). (4)
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OATP1B1/3 inhibitors, strong CYP3A inducers, and efavirenz. (4)
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If ZEPATIER is administered with ribavirin, the contraindications to ribavirin also apply. (
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