Elbasvir / grazoprevir
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: AKT
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Black Box Warning
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TITLE
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
See full prescribing information for complete Boxed Warning.
Condition Name:
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with ZEPATIER. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
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Overview
Elbasvir / grazoprevir is a combination of a hepatitis C virus NS5A inhibitor and a Hepatitis C virus NS3/4A protease inhibitor that is FDA approved for the treatment of chronic HCV genotype 1 or 4 infection in adults. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
ZEPATIER is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adults. ZEPATIER is indicated for use with ribavirin in certain patient populations. Dosing Information
- ZEPATIER is a two-drug, fixed-dose combination product containing 50 mg of elbasvir and 100 mg of grazoprevir in a single tablet.
- The recommended dosage of ZEPATIER is one tablet taken orally once daily with or without food. *ZEPATIER is used in combination with ribavirin in certain patient populations (see TABLE 1). When administered with ZEPATIER, the recommended dosage of ribavirin in patients without renal impairment is weight-based administered in two divided doses with food. For further information on ribavirin dosing and dosage modifications, refer to the ribavirin prescribing information.
- Treatment Regimen and Duration of Therapy
- Relapse rates are affected by baseline host and viral factors and differ between treatment regimens and durations for certain subgroups
- TABLE 1 below provides the recommended ZEPATIER treatment regimen and duration based on the patient population and genotype in HCV mono-infected and HCV/HIV-1 co-infected patients with or without cirrhosis and with or without renal impairment including patients receiving hemodialysis.
TABLE 1
- Renal Impairment
- No dosage adjustment of ZEPATIER is recommended in patients with any degree of renal impairment including patients on hemodialysis. Administer ZEPATIER with or without ribavirin according to the recommendations in TABLE 1. Refer to the ribavirin tablet prescribing information for the correct ribavirin dosage for patients with CrCl less than or equal to 50 mL per minute.
- Hepatic Impairment
- No dosage adjustment of ZEPATIER is recommended in patients with mild hepatic impairment (Child-Pugh A). ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Elbasvir and grazoprevir in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Elbasvir and grazoprevir in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Elbasvir / grazoprevir FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Elbasvir and grazoprevir in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Elbasvir and grazoprevir in pediatric patients.
Contraindications
- ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to the expected significantly increased grazoprevir plasma concentration and the increased risk of alanine aminotransferase (ALT) elevations.
- ZEPATIER is contraindicated with inhibitors of organic anion transporting polypeptides 1B1/3 (OATP1B1/3) that are known or expected to significantly increase grazoprevir plasma concentrations, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.
- If ZEPATIER is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.
TABLE 2
Warnings
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TITLE
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
See full prescribing information for complete Boxed Warning.
Condition Name:
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with ZEPATIER. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
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There is limited information regarding Elbasvir / grazoprevir Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Elbasvir / grazoprevir Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Elbasvir / grazoprevir Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Elbasvir / grazoprevir Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Elbasvir / grazoprevir in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Elbasvir / grazoprevir in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Elbasvir / grazoprevir during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Elbasvir / grazoprevir in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Elbasvir / grazoprevir in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Elbasvir / grazoprevir in geriatric settings.
Gender
There is no FDA guidance on the use of Elbasvir / grazoprevir with respect to specific gender populations.
Race
There is no FDA guidance on the use of Elbasvir / grazoprevir with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Elbasvir / grazoprevir in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Elbasvir / grazoprevir in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Elbasvir / grazoprevir in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Elbasvir / grazoprevir in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Elbasvir / grazoprevir Administration in the drug label.
Monitoring
There is limited information regarding Elbasvir / grazoprevir Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Elbasvir / grazoprevir and IV administrations.
Overdosage
There is limited information regarding Elbasvir / grazoprevir overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Elbasvir / grazoprevir Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Elbasvir / grazoprevir Mechanism of Action in the drug label.
Structure
There is limited information regarding Elbasvir / grazoprevir Structure in the drug label.
Pharmacodynamics
There is limited information regarding Elbasvir / grazoprevir Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Elbasvir / grazoprevir Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Elbasvir / grazoprevir Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Elbasvir / grazoprevir Clinical Studies in the drug label.
How Supplied
There is limited information regarding Elbasvir / grazoprevir How Supplied in the drug label.
Storage
There is limited information regarding Elbasvir / grazoprevir Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Elbasvir / grazoprevir Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Elbasvir and grazoprevir interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Elbasvir / grazoprevir Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Elbasvir / grazoprevir Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.