Sofomax^®

Sofomax® is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection. Sofomax® inhibits the RNA polymerase that the hepatitis C virus uses to replicate its RNA. Sofomax® is used for the treatment of chronic hepatitis C, genotypes 1, 2, 3, and 4. It is also used in combination with the viral NS5a inhibitor Ledipasvir in an interferon-free combination for the treatment of genotype 1 hepatitis C infection. Sofomax® is also used in HCV patients with an HIV co-infection.

No Data

Sofomax® is 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.

The recommended dosage of Sofomax® is one 400 mg tablet taken orally once daily with or without food.

Administer Sofomax® in combination with Ribavirin or in combination with Pegylated interferon and Ribavirin for the treatment of HCV. The recommended treatment regimen and duration for Sofomax® combination therapy is below -

Safety and effectiveness of Sofomax® in children less than 18 years of age have not been established.

Pregnancy category of Sofosbuvir: B

Use in renal impairment patients No dosage adjustment of Sofomax® is required for patients with mild or moderate renal impairment. The safety and efficacy of Sofomax® have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73m²) or ESRD requiring hemodialysis. No dosage recommendation can be given for patients with severe renal impairment or ESRD.

Use in hepatic impairment patients No dosage adjustment of Sofomax® is required for patients with mild, moderate or severe hepatic impairment. Safety and efficacy of Sofomax® have not been established in patients with decompensated cirrhosis.

Use in pediatric patients
Safety and effectiveness of Sofomax® in children less than 18 years of age have not been
established.

Patients who develop signs or symptoms of bradycardia should seek medical evaluation immediately. Symptoms may include near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, and confusion or memory problems.

The most common side effects of Sofomax® when used in combination with Ribavirin include:

• Tiredness
• Headache

The most common side effects of Sofomax® when used in combination with PEG interferon Alfa and Ribavirin include:

• Tiredness
• Headache
• Nausea
• Difficulty sleeping
• Low RBC count

Sofosbuvir is contraindicated in patients having Amiodarone, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine, Tipranavir and Ritonavir.

Sofosbuvir has drug-drug interactions with Cyclosporine, Darunavir, Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate, Methadone, Rilpivirine, and Tacrolimus.

There has been no report of toxicity from overdose. In case of accidental overdose supportive measure should be taken.

No Data

Sofomax® 400 mg tablet: Store in a cool (below 30° C) and dry place. Protect from light. Keep away from the reach of children

Sofomax® 400 mg tablet: Each coated tablet contains Sofosbuvir INN 400 mg.