What is ELBASVIR AND GRAZOPREVIR used for?

ELBASVIR AND GRAZOPREVIR (brand name ZEPATIER) is a Other indicated for a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor.

What are the most common side effects of ELBASVIR AND GRAZOPREVIR?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for ELBASVIR AND GRAZOPREVIR. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is ELBASVIR AND GRAZOPREVIR the same as ZEPATIER?

ZEPATIER is a brand name for ELBASVIR AND GRAZOPREVIR. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

ELBASVIR AND GRAZOPREVIR

Q: How does ELBASVIR AND GRAZOPREVIR work?

ELBASVIR AND GRAZOPREVIR works through the following mechanism: 12.1 Mechanism of Action ZEPATIER is a fixed-dose combination of elbasvir and grazoprevir which are direct-acting antiviral agents against the hepatitis C virus [see Microbiology (12.4) ]..

Other

Brand names: ZEPATIER

Oral

Mechanism of Action

12.1 Mechanism of Action ZEPATIER is a fixed-dose combination of elbasvir and grazoprevir which are direct-acting antiviral agents against the hepatitis C virus [see Microbiology (12.4) ].

Indications

a hepatitis C virus (HCV) NS5A inhibitor

and grazoprevir

an HCV NS3/4A protease inhibitor

Contraindications

• Use in Specific Populations (8.9)
• strong inducers of cytochrome P450 3A (CYP3A)
• and efavirenz [see Warnings and Precautions (5.5)
• Drug Interactions (7)
• and Clinical Pharmacology (12.3) ] . If ZEPATIER is administered with ribavirin

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment
2 ) Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease: Hepatic decompensation/failure, including fatal outcomes, have been reported mostly in patients with cirrhosis and baseline moderate or severe liver impairment (Child-Pugh B or C) treated with HCV NS3/4A protease inhibitor-containing regimens
3 ) Risk Associated with Ribavirin Combination Treatment: If ZEPATIER is administered with ribavirin, the warnings and precautions for ribavirin also apply
1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy

Known Side Effects

10 documented side effects by frequency

Fatigue

>10%

Headache

>10%

Nausea

>10%

Insomnia

1-10%

Diarrhea

1-10%

Vomiting

0.1-1%

Joint Pain

0.1-1%

Itching

0.1-1%

Dizziness

0.1-1%

Abdominal Pain

0.1-1%

Community Discussions

No community discussions found for ELBASVIR AND GRAZOPREVIR yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → ELBASVIR AND GRAZOPREVIR openFDA label JSON → ELBASVIR AND GRAZOPREVIR FAERS adverse-event reports → ELBASVIR AND GRAZOPREVIR ClinicalTrials.gov → completed Phase 2+ trials of ELBASVIR AND GRAZOPREVIR

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Formulations

Dosage Forms

Tablet

Route

Oral