Uses of Velsovir 400mg/100 mg: - Chronic hepatitis C virus (HCV) infection Chronic Hepatitis C Hypersensitivity.

Hepatic viral infections (Hepatitis C)

It is a fixed-dose combination tablet containing sofosbuvir and velpatasvir for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor and velpatasvir is an NS5A inhibitor.

How to use Sofosbuvir + Velpatasvir: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Sofosbuvir + Velpatasvir may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food Adult Dose: Oral Adult Chronic Hepatitis C Indicated for adults with chronic hepatitis C virus (HCV) infection genotypes 1, 2, 3, 4, 5, and 6 1 tablet (400 mg sofosbuvir/ 100 mg velpatasvir) qDay Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Sofosbuvir/velpatasvir for 12 weeks Patients with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir/velpatasvir plus weight-based ribavirin with food for 12 weeks Hepatic impairment Mild, moderate, or severe (Child-Pugh A, B, or C): No dosage adjustment required Child Dose: Safety and efficacy not established Renal Dose: Renal impairment Severe renal impairment (eGFR <30mL/min/1.73 m²) or ESRD: No dosage recommendation can be give owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite

Coadministration with drugs that increase gastric pH are expected to decrease velpatasvir serum concentration

Hypersensitivity.

Common - Headache - Tiredness >10% Without cirrhosis or with compensated cirrhosis Headache (22%),Fatigue (15%) With decompensated cirrhosis Fatigue (32%),Anemia (26%),Hemoglobin <10 g/dL (23%),Nausea (15%),Headache 11%),Insomnia (11%) 1-10% Without cirrhosis or with compensated cirrhosis Nausea (9%),Asthenia (5%),Insomnia (5%),Lipase increase >3 x ULN (3%),Rash (2%),Depression (1%),Increased creatinine kinase >10 x ULN (1%) With decompensated cirrhosis Diarrhea (10%) Hemoglobin <3.5 g/dL (7%),Rash (5%),Increased creatinine kinase ≥10 x ULN (2%)

No adequate human data are available to establish whether or not Sofosbuvir and Velpatasvir combination poses a risk to pregnancy outcomes. If Sofosbuvir and Velpatasvir combination administered with Ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partner is pregnant or going to be pregnant in next six months.

Precaution: Direct-acting antivirals (DDAs) may reactivate hepatitis B virus (HBV) in patients who have a current or previous HBV infection while being treated for hepatitis C virus In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death Patients should be screened for evidence of current or prior HBV infection before starting treatment with DAAs, and monitored for HBV flare-ups or reactivation during DAA treatment and posttreatment follow-up Serious symptomatic bradycardia may occur if sofosbuvir is coadministered with amiodarone in combination with another direct-acting antiviral (eg, daclatasvir, simeprevir) Lactation: Unknown if sofosbuvir, velpatasvir, or their metabolites are distributed in human breast milk

If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose includes monitoring of vital signs as well as observation of the clinical status of the patient.

Store in a cool and dry place (preferably below 30° C). Keep out of reach of children.

Hepatic viral infections (Hepatitis C)

Sofosbuvir: Inhibitor of HCV NS5B RNA-dependent polymerase; its inhibition, in turn, suppresses viral replication Velpatasvir: Pangenotypic HCV NS5A inhibitor; the NS5A protein is required for viral replication

No adequate human data are available to establish whether or not Sofosbuvir and Velpatasvir combination poses a risk to pregnancy outcomes. If Sofosbuvir and Velpatasvir combination administered with Ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partner is pregnant or going to be pregnant in next six months.