Epclusa
E413592
Epclusa is a prescription antiviral medication used to treat chronic hepatitis C infection across all major genotypes.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Epclusa canonical | 3 |
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
antiviral medication
ⓘ
direct-acting antiviral ⓘ fixed-dose combination drug ⓘ prescription drug ⓘ |
| approvedBy |
Food and Drug Administration
ⓘ
surface form:
U.S. Food and Drug Administration
|
| ATCCode | J05AP55 ⓘ |
| canBeUsedWith | ribavirin in certain patients with decompensated cirrhosis ⓘ |
| containsDoseOfSofosbuvir | 400 mg ⓘ |
| containsDoseOfVelpatasvir | 100 mg ⓘ |
| contraindicatedWith |
strong CYP2B6 inducers
ⓘ
strong CYP2C8 inducers ⓘ strong CYP3A4 inducers ⓘ strong P-gp inducers ⓘ |
| developer |
Gilead Sciences (board member)
ⓘ
surface form:
Gilead Sciences
|
| dosageForm | film-coated tablet ⓘ |
| eliminationRoute |
biliary excretion of velpatasvir
ⓘ
renal excretion of sofosbuvir metabolite ⓘ |
| FDAApprovalYear | 2016 ⓘ |
| hasActiveIngredient |
sofosbuvir
ⓘ
velpatasvir ⓘ |
| hasBrandName | Epclusa self-link ⓘ |
| hasCommonAdverseEffect |
anemia when used with ribavirin
ⓘ
fatigue ⓘ headache ⓘ insomnia ⓘ nausea ⓘ |
| hasGenericName | sofosbuvir and velpatasvir ⓘ |
| hasIndication | pan-genotypic hepatitis C treatment ⓘ |
| indicatedFor |
adults with chronic hepatitis C
ⓘ
pediatric patients 3 years and older with chronic hepatitis C ⓘ |
| legalStatusInUnitedStates | prescription only ⓘ |
| manufacturer | Gilead Sciences ONNED1 ⓘ |
| mechanismOfAction |
NS5A inhibition via velpatasvir
ⓘ
NS5B polymerase inhibition via sofosbuvir ⓘ |
| metabolism | primarily hepatic ⓘ |
| pregnancyCategory | requires risk–benefit assessment, especially with ribavirin ⓘ |
| requiresMonitoringOf |
HCV RNA levels
ⓘ
hepatitis B virus reactivation risk ⓘ liver function tests ⓘ |
| routeOfAdministration | oral ⓘ |
| takenOnce | daily ⓘ |
| treats |
chronic hepatitis C virus infection
ⓘ
hepatitis C genotype 1 ⓘ hepatitis C genotype 2 ⓘ hepatitis C genotype 3 ⓘ hepatitis C genotype 4 ⓘ hepatitis C genotype 5 ⓘ hepatitis C genotype 6 ⓘ |
| typicalTreatmentDuration | 12 weeks ⓘ |
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.
subject surface form:
Gilead Sciences
subject surface form:
Velpatasvir