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MyHep ALL

MyHep ALL

sofosbuvir + velpatasvir

Manufacturer:

Mylan

Distributor:

DKSH

Marketer:

Meda Pharma
Concise Prescribing Info
Contents
Sofosbuvir 400 mg, velpatasvir 100 mg
Indications/Uses
Chronic HCV infection (genotype 1, 2, 3, 4, 5 or 6) in adults.
Dosage/Direction for Use
1 tab once daily. Treatment duration: Patient w/o cirrhosis, patient w/ compensated cirrhosis 12 wk. Consider addition of ribavirin for genotype 3 infected patient w/ compensated cirrhosis. Patient w/ decompensated cirrhosis In combination w/ ribavirin for 12 wk. Patient who previously failed therapy w/ NS5A-containing regimen In combination w/ ribavirin for 24 wk.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Apply ribavirin contraindications if in combination w/ ribavirin. Concomitant use w/ potent P-glycoprotein (P-gp) & cytochrome P450 (CYP) inducers eg, rifampicin, rifabutin, St. John's wort (Hypericum perforatum), carbamazepine, phenobarb & phenytoin.
Special Precautions
Should not be administered concurrently w/ sofosbuvir-containing drugs. Closely monitor patients upon initiating treatment & continuously for 48 hr (for patients at high risk for bradyarrhythmia) when used concomitantly w/ amiodarone & w/in the past few mth after discontinuation of amiodarone. Patients who have previously failed therapy w/ NS5A-containing regimen. Not recommended for co-administration w/ moderate P-gp or CYP inducers (eg, oxcarbazepine, modafinil or efavirenz). Concomitant use w/ elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or w/ tenofovir disoproxil fumarate given in conjunction w/ boosted HIV PIs. Perform HBV screening before initiation of treatment. Patients w/ CPT class C cirrhosis. Post-liver transplant patients. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Severe renal impairment (eGFR <30 mL/min/1.73 m2); end-stage renal disease (ESRD) requiring haemodialysis. Pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Headache, fatigue & nausea. Sofosbuvir: Severe bradycardia & heart block.
Drug Interactions
May increase exposure of P-gp, breast cancer resistance protein (BRCP), organic anion-transporting polypeptide (OATP) 1B1 & OATP1B3 substrates; tenofovir. Increase conc of digoxin, rosuvastatin. Decreased plasma conc w/ potent P-gp or CYP2B6, CYP2C8, CYP3A4 (eg, rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarb & phenytoin) inducers; moderate P-gp or CYP inducers (eg, oxcarbazepine, modafinil or efavirenz). Increased plasma conc w/ P-gp or BCRP inhibitors. Increased plasma conc w/ OATP, CYP2B6, CYP2C8, or CYP3A4 inhibitors. Decreased conc w/ acid reducing agents; efavirenz/emtricitabine/tenofovir disoproxil fumarate. May decrease AUC & Cmax w/ proton pump inhibitors (omeprazole, lasoprazole, rabeprazole, pantoprazole, esomeprazole). May increase conc of digoxin & rosuvastatin. Reduce therapeutic effect w/ rifapentine. Statins.
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
MyHep ALL FC tab 400 mg/100 mg
Packing/Price
28's
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