SoviHep

SoviHep tablets are administered orally.Each tablet contains 400 mg of sofosbuvir.


Description

SoviHep tablets are administered orally.Each tablet contains 400 mg of SoviHep.

INDICATIONS AND USAGE

SoviHep is indicated in combination with other medical products for the treatment of chronic hepatitis C (CHC) in adults.

DOSAGES AND ADMINISTRATION

Recommended Dose in adults

The recommended dose of SoviHep is one 400 mg tablet, taken orally, once daily with or without food SoviHep should be used combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC in adults.The recommended regimen and treatment duration for the SoviHep combination therapy is provided in following table.

Recommended Regimens and Treatments Duration for SoviHep Combination Therapy in HCV Mono-infected and HCH/HIV-1 Co-infected Patients

   Treatment  Duration
 Patients with genotype 1 of 4 CHC  SoviHep + peginsterferon alfaa   +ribavirinb  12 weeks
 Patients with genotype 2 CHC  SoviHep+ ribavirinb  12 weeks
 Patients with genotype 3 CHC  SoviHep+ ribavirinb  24 weeks

Dose Modification

Dose reduction of SoviHep is not recommended.

Genotype 1 and 4:

If a patients has a serious adverse reaction potentially related to peginterferon alfa and /or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the peginterferon alfa and ribavirin prescribing information for the additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.

Genotype 2 and 3:

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 sverity.Provides guidelines for dose modifications and discontinuation based on the patient’s hemoglobin concentration and cardiac status.

DOSAGES FORMS AND STRENGTHS

Each film coated tablet of SoviHep 400 mg is available as capsules shaped, brick red colored and debossed with 400 on one side and plain on another side.

CONTRAINDICATIONS

SoviHep is used in combination with ribavirin to peginterferon alfa/ribavirin; the contraindications applicable to those agents are applicable to combination therapies. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

WARNINGS AND PRECAUTIONS

Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin

Ribavirin may cause birth defects and /or deaths of the exposed fetus and animal have shown that interferons have abortifacient effects. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.

When SoviHep is used in combinations with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential and their male partners must use two forms of effective contraception during treatment and for at least 6 months after treatment .Monthly pregnancy tests must be performed during this time. There are no data on the effectiveness of systemic hormonal contraceptives in women taking SoviHep  therefore, two non-hormonal methods of contraception should be used during treatment with SoviHep and concomitant ribavirin.

ADVERSE  REACTIONS

The most common adverse events (>=20%) for SoviHep + ribavirin combination therapy were fatigue and headache. The most common adverse events (>=20%) for SoviHep + peginterferon alfa+ ribavirin combination therapy were fatigue, headache, nausea, in-somnia and anemia.

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