Simeprevir
- TRADE NAME: Olysio (Janssen)
- INDICATIONS: Hepatitis C
- CLASS: Direct-acting antiviral, Hepatitis C virus NS3/4A protease inhibitor
- HALF-LIFE: 10–13 hours
FDA APPROVAL DATE: 11/22/2013
CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:Atazanavir, Carbamazepine, Cisapride, Clarithromycin, Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Disoproxil, Darunavir, Delavirdine, Dexamethasone, Efavirenz, Erythromycin, Etravirine, Fluconazole, Fosamprenavir, Indinavir, Itraconazole, Ketoconazole, Ledipasvir & Sofosbuvir, Lopinavir, Milk Thistle, Nelfinavir, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Posaconazole, Rifabutin, Rifampin, Rifapentine, Ritonavir, Saquinavir, St John's Wort, Telithromycin, Tipranavir, Voriconazole
PREGNANCY CATEGORY: X
simeprevir is pregnancy category C but must not be used in monotherapy
Must be used in combination with PEG-interferon and ribavirin (see separate entries).
See full prescribing information for complete boxed warning.
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Page last updated 07/31/2023
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Incidence 
- <1%
- 1-5%
- 5-10%
- 10-15%
- 15-20%
- 20-30%
- >30%
Seriousness
- Hospitalization possible
- Life threatening
- Fatal
Warnings in other populations
- Breast feeding
- Geriatric
- Pediatric
