Epclusa

Epclusa

sofosbuvir + velpatasvir

Manufacturer:

Gilead Sciences

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Sofosbuvir 400 mg, velpatasvir 100 mg
Indications/Uses
Dosage/Direction for Use
1 tab once daily. Patient w/o cirrhosis & patient w/ compensated cirrhosis Epclusa for 12 wk. Addition of ribavirin may be considered for genotype 3-infected patients w/ compensated cirrhosis: Ribavirin: 1,000 mg for patients <75 kg; 1,200 mg for patients ≥75 kg. Patient w/ decompensated cirrhosis Epclusa + ribavirin for 12 wk. Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant Ribavirin 1,000 mg/day for patients <75 kg; 1,200 mg for patients ≥75 kg. CPT Class C cirrhosis pre-transplant, CPT Class B or C post-transplant Ribavirin: Initially 600 mg, can be titrated up to a max of 1,000 mg for patients <75 kg or 1,200 mg for patients ≥75 kg if well tolerated. Patient who have previously failed therapy w/ an NS5A-containing regimen Epclusa + ribavirin for 24 wk may be considered.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Co-administration w/ strong P-gp &/or strong CYP450 inducers (eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin, St. John's wort).
Special Precautions
Risk of severe bradycardia & heart block when sofosbuvir-containing regimens are used in combination w/ amiodarone. Risk of HBV reactivation in HBV/HCV co-infected patients. HBV screening should be performed in all patients before initiation of treatment. Do not administer w/ other sofosbuvir-containing medicinal products. Not recommended w/ moderate P-gp &/or moderate CYP inducers (eg, efavirenz, modafinil, oxcarbazepine or rifapentine). Patients receiving concomitant elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate & a boosted HIV PI should be monitored for tenofovir-associated adverse reactions. Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia. Patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m2) & end stage renal disease requiring haemodialysis. Patients w/ CPT Class C cirrhosis; post-liver transplant patients. Not recommended during pregnancy. Should not be used during breast-feeding. Childn & adolescents <18 yr.
Adverse Reactions
Drug Interactions
Increased conc of P-gp (eg, digoxin, dabigatran etexilate), BCRP (eg, rosuvastatin), OATP1B1 & OATP1B3 substrates. Decreased plasma conc w/ strong P-gp &/or strong CYP2B6, CYP2C8, or CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin, St. John's wort); moderate P-gp &/or moderate CYP inducers (eg, efavirenz, modafinil, oxcarbazepine, rifapentine). Increased plasma conc w/ P-gp or BCRP inhibitors. Increased velpatasvir plasma conc w/ OATP, CYP2B6, CYP2C8, or CYP3A4 inhibitors. Close monitoring of INR is recommended in patients treated w/ vit K antagonists. Altered pharmacokinetics of drugs metabolized by the liver [eg, immunosuppressive agents (eg, ciclosporin & tacrolimus)]. Decreased velpatasvir conc w/ acid reducing agents including antacids (Al or Mg hydroxide, Ca carbonate), H2-receptor antagonists (famotidine, cimetidine, nizatidine, ranitidine), proton pump inhibitors (omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole). May result in serious symptomatic bradycardia when sofosbuvir is co-administered w/ amiodarone. Increased exposure of tenofovir disoproxil fumarate. Potential increased conc of statins other than atorvastatin & pravastatin.
MIMS Class
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 400/100 mg
Packing/Price
28's
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