Virussof ®

►General dosing considerations: Do not use as monotherapy; use only in combination with ribavirin or in combination with peginterferon alfa and ribavirin.

►Adults

Chronic hepatitis C: 400 mg once daily

Maximum dose: 400 mg once daily

Missed dose: If you miss a dose of sofosbuvir, take as soon as possible the same day. Do not take more than one tablet in a day, take your next dose of sofosbuvir at your regular time the next day.

►Renal Impairment: No dosage adjustment necessary. (has not been studied).

►Hepatic Impairment: No dosage adjustment necessary. (has not been studied).

 ►Administration: May be taken with or without food.

Contraindications:

All contraindications also applicable to ribavirin and peginterferon alfa including women who are pregnant or who may become pregnant and use by male partners of pregnant women.

Interactions:

• Amiodarone: Sofosbuvir may enhance the bradycardic effect of Amiodarone. Avoid combination
• Oxcarbazepine: May decrease the serum concentration of Sofosbuvir.Avoid combination
• Rifabutin: May decrease the serum concentration of Sofosbuvir.Avoid combination
• Rifapentine: May decrease the serum concentration of Sofosbuvir. Avoid combination

Pregnancy and Lactation:

FDA Pregnancy: Category B

Category X (in combination with ribavirin or peginterferon alfa/ribavirin)

sofosbuvir is only to be used in combination with ribavirin or peginterferon alfa/ribavirin for the treatment of hepatitis C virus (HCV), therefore use is contraindicated in pregnancy. A negative pregnancy test is required before initiation and monthly thereafter.

Breast feeding: It is not known whether sofosbuvir excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Warning and Precaution:

► Appropriate use: Do not use as monotherapy; use only in combination with ribavirin (with or without peginterferon alfa depending upon the clinical indication).

► Pregnancy: Combination therapy with ribavirin may cause birth defects and/or death of the exposed fetus; avoid pregnancy in females and female partners of male patients during therapy and for at least 6 months following treatment; two nonhormonal forms of effective contraception must be used. Combination therapy with ribavirin is contraindicated in pregnancy.

►Monitoring Parameters

Monitor bilirubin, liver enzymes, and serum creatinine at baseline and periodically when clinically indicated.

Serum HCV-RNA at baseline, during treatment, at the end of treatment, during treatment follow-up, and when clinically indicated.

Pretreatment and monthly pregnancy tests up to 6 months following discontinuation of therapy for women of childbearing age.

Adverse Reactions:

Incidence>10%

Fatigue, headache, insomnia, chills, irritability, pruritus, skin rash, nausea, decreased appetite, diarrhea, decreased hemoglobin, neutropenia, decreased neutrophils, Weakness, myalgia, flu-like symptoms, fever

 

Incidence<10%

Increased serum lipase, thrombocytopenia, increased creatine kinase.

Storage:

Store below 30 and protect from light and moisture.