Velpanat

Velpanat

sofosbuvir + velpatasvir

Manufacturer:

Natco Pharma

Distributor:

Integrated Market Services
Concise Prescribing Info
Contents
Sofosbuvir 400 mg, velpatasvir 100 mg
Indications/Uses
Dosage/Direction for Use
Patient w/o cirrhosis & w/ compensated cirrhosis 1 tab for 12 wk. Addition of ribavirin may be considered for genotype 3 infected patient w/ compensated cirrhosis. Child-Pugh-Turcotte (CPT) class B cirrhosis pre-transplant: Patient weighing >75 kg 1,000 mg/day, <75 kg 1,200 mg. CPT class C cirrhosis pre-transplant & CPT class B or C post-transplant Initially 600 mg, then may titrate up to max of 1,000 for patient weighing >75 kg, or 1,200 mg for patient <75 kg. Patient w/ decompensated cirrhosis 1 tab for 12 wk. Patient who have previously failed therapy w/ NS5A-containing regimen Sofosbuvir & velpatasvir tab + ribavirin for 24 wk.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Co-administration w/ potent P-glycoprotein (P-gp) or cytochrome P450 (CYP450) inducers eg, rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarb & phenytoin.
Special Precautions
Do not co-administer w/ other drugs containing sofosbuvir. Severe bradycardia & heart block w/ amiodarone. Patients at high risk of bradyarrhythmia should be continuously monitored for 48 hr. Symptoms of bradycardia & heart block in combination w/ amiodarone or drugs that lower heart rate. Monitor tenofovir-associated adverse reactions when in concomitant use w/ fixed-dose combination drugs containing tenofovir. Patients w/ HCV/HBV co-infection; CPT class C cirrhosis; post-liver transplant. Severe renal impairment or ESRD requiring hemodialysis. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Headache, fatigue & nausea. Severe bradycardia & heart block (when in combination w/ another direct acting antiviral).
Drug Interactions
Reduced therapeutic effect w/ moderate P-gp or moderate CYP inducers (eg, oxcarbazepine, modafinil or efavirenz). Increased plasma conc w/ P-gp or BCRP inhibitors. Increased plasma conc of velpatasvir w/ OATP, CYP2B6, CYP2C8 or CYP3A4 inhibitors. Decreased solubility of velpatasvir w/ acid-reducing agents. Decreased Cmax & AUC w/ famotidine, omeprazole, rifampicin, rifabutin. Decreased conc w/ carbamazepine, phenytoin, phenobarb & oxcarbazepine. Increase conc of rosuvastatin & statins. Velpatasvir: Increased Cmax, AUC w/ digoxin; ketoconazole, itraconazole, voriconazole, posaconazole, isavuconazole; rosuvastatin, pravastatin. Decreased Cmax, AUC w/ efavirenz, emtricitabine, tenofovir disoproxil fumarate.
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
Velpanat FC tab
Packing/Price
28's
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