Product List

Generic:

Sofosbuvir

Therapeutic Class:

Composition:

Each MyHep film coated tablet
contains Sofosbuvir 400 mg

Description:

MyHep (Sofosbuvir) is a
nucleotide analog inhibitor of HCV NS5B polymerase. MyHep is a
direct-acting antiviral agent against the hepatitis C virus

Indications:

MyHep tablet is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults & for hepatitis C virus (HCV) genotype specific activity.

Dosage:

MyHep tablets treatment should be initiated and
monitored by a physician experienced in the management of patients with
CHC.

The recommended dose is one MyHep 400 mg tablet, taken orally, once daily with food. MyHep tablets should be used in combination with other medicinal products. Monotherapy of MyHep tablets is not recommended.

The recommended co-administered medicinal product(s) and treatment duration for MyHep tablets combination therapy.

Recommended
co-administered medicinal product(s) and treatment duration for MyHep
tablets combination therapy

For Patients* with genotype 1,
4, 5 or 6 CHC:

MyHep + Ribavirin + Peginterferon alfa for 12 weeks a,b
MyHep + Ribavirin (Only for use in patients ineligible or intolerant to peginterferon alfa for 24 weeks

For Patients* with genotype 2 CHC:
MyHep + Ribavirin + Peginterferon alfa for 12 weeksb

For Patients* with genotype 3 CHC:
MyHep + Ribavirin + Peginterferon alfa for 12 weeks b
MyHep + Ribavirin for 24 weeks

For Patients* with CHC awaiting liver transplantation:
MyHep + Ribavirin until liver transplantationc

* Includes patients co-infected with human immunodeficiency virus (HIV).

a. For previously treated patients with HCV genotype 1 infection, no data exists with the combination of MyHep tablets, ribavirin and peginterferon alfa.

b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).

c. See Special patient populations – Patients awaiting liver transplantation below.

The dose of ribavirin, when used in combination with MyHep tablets is
weight-based (<75 kg = 1,000 mg and =75 kg = 1,200 mg) and administered
orally in two divided doses with food.

Dose modification:

Dose reduction of Sofosbuvir 400
mg film-coated tablets is not recommended.

If MyHep is used in combination with peginterferon alfa, and a patient has
a serious adverse reaction potentially related to this drug, the
peginterferon alfa dose should be reduced or discontinued. 

If a patient has a serious adverse reaction potentially related to
ribavirin, the ribavirin dose should be modified or discontinued, if
appropriate, until the adverse reaction abates or decreases in severity.

Ribavirin dose
modification guideline for co-administration with Sofosbuvir 400 mg
film-coated tablets

Reduce ribavirin dose to 600 mg/ day in subjects with no cardiac disease & having haemoglobin <10 g/dL & if haemoglobin is < 8.5 g/dL
discontinue ribavirin.

Reduce ribavirin dose to 600 mg/ day in subjects with history of stable cardiac disease & having > 2 g/dL decrease in haemoglobin during any 4 weeks treatment period.

Once ribavirin has been withheld due to either a laboratory abnormality or
clinical manifestation, an attempt may be made to restart ribavirin at 600
mg daily and further increase the dose to 800 mg daily. However, it is not
recommended that ribavirin be increased to the original assigned dose (1000
mg to 1200 mg daily).

Presentations:

400 mg Tabs 28’s