Sofosvel400mg+100mg
Type:Tablet
Generic Name:Sofosbuvir + Velpatasvir
Manufacturer:Beacon Pharmaceuticals Ltd.
Price:৳1170.00
Indication
Chronic Hepatitis C
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
Contraindication
Hypersensitivity.
Mode of Action
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
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
Side Effect
>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%)
Interaction
Coadministration with drugs that increase gastric pH are expected to decrease velpatasvir serum concentration
