Epclusa

Epclusa

sofosbuvir + velpatasvir

Manufacturer:

Gilead

Distributor:

A. Menarini
Concise Prescribing Info
Contents
Sofosbuvir 400 mg, velpatasvir 100 mg
Indications/Uses
Chronic hepatitis C virus (HCV) infection in adult.
Dosage/Direction for Use
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Co-administration w/ potent P-gp & potent CYP450 inducers (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarb & phenytoin).
Special Precautions
Severe bradycardia & heart block when sofosbuvir used in combination w/ another direct acting antiviral is used concomitantly w/ amiodarone w/ or w/o other drugs that lower heart rate. May decrease plasma conc w/ moderate P-gp or moderate CYP inducers. Increased risk of renal dysfunction w/ certain HIV antiretroviral regimens & boosted HIV PIs. HCV/HBV co-infected patients are at risk of HBV reactivation. Patients w/ CPT Class C cirrhosis. Liver transplant patients. Severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD requiring hemodialysis. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Drug Interactions
May increase exposure when is co-administration w/ sensitive substrates of P-gp (digoxin), BCRP (rosuvastatin) & OATP (pravastatin). Contraindicated w/ potent inducers of P-gp or of CYP2B6, CYP2C8, CYP3A4 (eg, rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarb, phenytoin) as may lead to reduced therapeutic effect. Not recommended w/ moderate P-gp inducers or CYP inducers (eg, oxcarbazepine, modafinil, efavirenz) as may decrease sofosbuvir or velpatasvir plasma conc. May increase plasma conc w/ P-gp or BCRP inhibitor, or inhibitors of OATP, CYP2B6, CYP2C8 or CYP3A4. Liver function may change during treatment w/ vit K antagonists.
MIMS Class
Antivirals
ATC Classification
J05AP55 - sofosbuvir and velpatasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
Presentation/Packing
Form
Epclusa FC tab
Packing/Price
28's (P735/film-coated tab)
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