It Is a hepatItIs C vIrus (HCV) nucleotIde analog NS5B polymerase InhIbItor IndIcated for the treatment of genotype 1, 2, 3 or 4 chronIc hepatItIs C vIrus (HCV) InfectIon as a component of a combInatIon antIvIral treatment regImen.
Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator. More specifically, Sofosbuvir prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material
One 400 mg tablet taken once daily with or without food. ? Should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of HCV. Recommended combination therapy: Patient Population Treatment Duration Genotype 1 or 4 It + peg-interferon alfa + ribavirin 12 weeks Genotype 2 It + ribavirin 12 weeks Genotype 3 It + ribavirin 24 weeks ? HCV/HIV-1 co-infection: For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in the table above. ? It in combination with ribavirin for 24 weeks can be considered for patients with genotype 1 infection who are interferon ineligible. ( ? Should be used in combination with ribavirin for treatment of HCV in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first. ? A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease.
Reduced therapeutic effect with drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/ oxcarbazepine, rifabutin/ rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered with amiodarone in combination with another direct acting antiviral.
When used in combination with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/or ribavirin also apply to It combination therapy. Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone and It in combination with another direct acting antiviral (DAA), particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with It in combination with another DAA is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended. ? Use with other drugs containing sofosbuvir is not recommended
fatigue, headache, nausea, insomnia and anemia.
Pregnancy Category B: Sofosbuvir There are no adequate and well-controlled studies with Sofosbuvir in pregnant women.
Nursing Mothers: It is not known whether Sofosbuvir and its metabolites are present in human breast milk.
The highest dose of Sofosbuvir is a single dose of Sofosbuvir 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with Sofosbuvir consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Keep out of the reach of children. Keep in a cool & dry place. Protect from light.
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