ZEPATIER (ELBASVIR AND GRAZOPREVIR)
ZEPATIER (ELBASVIR AND GRAZOPREVIR) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: ZEPATIER; Generic name: ELBASVIR AND GRAZOPREVIR; Drug class: Hepatitis C Virus NS5A Inhibitor [EPC].
| Brand name | ZEPATIER |
|---|---|
| Generic name | ELBASVIR AND GRAZOPREVIR |
| Drug class | Hepatitis C Virus NS5A Inhibitor [EPC] |
| Manufacturer | Merck Sharp & Dohme LLC |
| Used for | 1 INDICATIONS AND USAGE ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ] . 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 for treatment of chronic HCV genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certa |
| Dosage | 2 DOSAGE AND ADMINISTRATION Testing Prior to Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. ( 2.1 ) Genotype 1a: Testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended. ( 2.1 ) Obtain hepatic laboratory testing. ( 2.1 ) Recommended dosage in adult and pediatric patients 12 years of age and older or weighing at least 30 kg: One tablet taken orally once daily with or without food. ( 2.2 ) Dosage Regimens and Durat |
| Warnings | WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV 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/HB |
| Active ingredient(s) | ELBASVIR |
| Route | ORAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164dc02a-9180-426a-b8b5-04ab39d2bbd4 |