Fosbu

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Fosbu Product Information Leaflets
Brand Name:
Fosbu
Generic Name:
FOSBU (Sofosbuvir 400mg)

DESCRIPTION:

Sofosbuvir is a hepatitis C virus (HCV) nucleotide analog NSSB polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

COMPOSITION:

Fosbu 400mg Tablets: Each film coated tablet contains: Sofosbuvir 400mg.

INDICATIONS:

It is used in the treatment of chronic hepatitis C genotypes 1,2,3 or 4. It is given an oral dose of 400mg once daily in a combined regimen according to genotype. It should be considered when initiating treatment with Fosbu(Sofosbuvir); monotherapy of sofosbuvir is not recommended for treatment of chronic hepatitis C and the treatment regimen and the duration are dependent on both viral genotype and patient population.

DOSAGE & ADMINISTRATION:

An oral dose of one 400mg tablet Fosbu (Sofosbuvir) taken once daily with or without food. It should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C.

CONTRAINDICATIONS:

When used in combination with peginterferon aft/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/or ribavirin also apply to Fosbu (Sofosbuvir) combination therapy.

UNDESIRABLE EFFECTS:

The reported adverse events of sofosbuvir with ribavirin therapy and peginterferon alfa are fatigue, headache, nausea, insomnia, anemia, pruritus, asthenia, rash, decreased appetite, chills, influenza like illness, pyrexia, diarrhea, neutropenia, myalgia and irritability. The other reported adverse events are pancytopenia (particularly in subjects receiving concomitant pegylated interferon), severe depression (particularly in subjects with pre-existing history of psychiatric illness), including suicidal ideation and suicide. Laboratory changes include bilirubin elevation, creatine kinase elevation and lipase elevation.

PRESENTATION:

Fosbu 400mg Tablets

PREGNANCY & LACTATION:

Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective non-hormonal methods of contraception and have monthly pregnancy tests.

Patients should consult with their physician before taking any medicine.