Sovel Tablet
Sofosbuvir + Velpatasvir
400 mg+100 mg
ACI Limited
| Pack size | 7's pack |
|---|---|
| Unite Price | 1000.00 BDT |
Indications
Sovel Tablet is used for:
Chronic Hepatitis C
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
Administration
May be taken with or without food
Contra Indications
Hypersensitivity.
Precautions
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
Pregnancy-Lactation
Pregnancy
Contraindicated if administered with ribavirin in pregnant women and in men whose female partners are pregnant
There are no adequate data available to establish pregnancy risk for sofosbuvir or velpatasvir
Lactation
Unknown if sofosbuvir, velpatasvir, or their metabolites are distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Coadministration with drugs that increase gastric pH are expected to decrease velpatasvir serum concentration
Side Effects
Side effects of Sofosbuvir + Velpatasvir :
>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%)
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
Note
Sovel 400 mg+100 mg Tablet generic name is Sofosbuvir + Velpatasvir. Sovel 400 mg+100 mg Tablet is manufactured by ACI LimitedSovel is availble in all over Bangladesh.
Mes BD drug index information on Sovel Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.