FOSBU V

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FOSBU V Product Information Leaflets
Brand Name:
Fosbu V
Generic Name:
Fosbu V (sofosbuvir + velpatasvir)

DESCRIPTION:

FOSBU V is a fixed-dose combination tablet containing sofosbuvir and velpatasvir for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor and velpatasvir is a NS5B inhibitor.

COMPOSITION:

FOSBU V 400mg/100mg Tablets. Each film coated tablet contains: Sofosbuvir ...... 400mg Velpatasvir ...... 100mg

INDICATIONS:

FOSBU V (sofosbuvir and velpatasvir) is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5, or 6 infection: without cirrhosis or with compensated cirrhosis and with decompensated cirrhosis for use in combination with ribavirin.

DOSAGE & ADMINISTRATION:

Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with FOSBU V (sofosbuvir and velpatasvir. The recommended dosage of FOSBU V (sofosbuvir and velpatasvir) is one tablet taken orally once daily with or without food. One tablet of FOSBU V (sofosbuvir and velpatasvir) contains 400mg of sofosbuir and 100 mg of velpatasvir. No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min) or with end stage renal disease (ESRD), due to higher exposures (up to 20-fold) of the predominant sofobuvir metabolite.

CONTRAINDICATIONS:

FOSBU V (sofosbuvir and velpatasvir) and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.

UNDESIRABLE EFFECTS:

The reported adverse reactions are serious symptomatic bradycardia, headache, fatigue, asthenia, anemia, nausea, insomnia, irritability, diarrhea, rash, depression, decrease in hemoglobin, lipase elevation, creatinine, kinase elevation, increases in indirect bilirubin, skin rashes, sometimes with blisters, angioedema-like swelling angioedema, pruritis, chills, decreased appetite, pyrexia, and myalgia. If it is administered with ribavirin, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions.

Patients should consult with their physician before taking any medicine.