Soventa
Generic Name
Sofosbuvir
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| soventa 400 mg tablet | ৳ 600.00 | ৳ 3,600.00 |
Description
Overview of the medicine
Soventa 400 mg Tablet contains Sofosbuvir, an antiviral medication used in combination with other drugs to treat chronic Hepatitis C virus (HCV) infection in adults and adolescents.
Uses & Indications
Dosage
Adults
One 400 mg tablet orally once daily with or without food, in combination with other direct-acting antivirals.
Elderly
No specific dose adjustment required based on age.
Renal_impairment
No dose adjustment needed for mild to moderate renal impairment. Not recommended for severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease (ESRD) requiring hemodialysis due to lack of data.
How to Take
Take orally once daily with or without food. Should always be used in combination with other direct-acting antiviral agents. Do not crush or chew the tablet.
Mechanism of Action
Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor. It inhibits the RNA-dependent RNA polymerase enzyme essential for HCV replication, thereby stopping the virus from multiplying.
Pharmacokinetics
Onset
Rapid, within hours of first dose, significant viral load reduction within days.
Excretion
Mainly renal (approx. 80% as GS-331007), also feces (approx. 14%).
Half life
Sofosbuvir: 0.5 hours; active metabolite (GS-331007): 27 hours.
Absorption
Rapidly absorbed, peak plasma concentration reached within 0.5-2 hours.
Metabolism
Primarily metabolized in the liver to the pharmacologically active nucleoside triphosphate (GS-461203) and then to the inactive metabolite (GS-331007).
Side Effects
Contraindications
- Hypersensitivity to Sofosbuvir or any component of the formulation.
- Monotherapy with Sofosbuvir is not recommended.
Drug Interactions
Amiodarone
Risk of severe symptomatic bradycardia, especially when co-administered with other DAAs (e.g., daclatasvir, ledipasvir, velpatasvir).
P-gp Inducers (e.g., Rifampin, St. John's Wort)
May significantly decrease Sofosbuvir plasma concentrations, leading to reduced therapeutic effect. Coadministration is not recommended.
Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital
May decrease Sofosbuvir concentrations.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management involves general supportive measures, including monitoring vital signs and observing for clinical status. Sofosbuvir and its main metabolite are not efficiently removed by hemodialysis.
Pregnancy & Lactation
Pregnancy Category B (animal studies showed no harm, but human data limited). Use only if potential benefit justifies potential risk to the fetus. Lactation: Unknown if excreted in human milk; use with caution.
Side Effects
Contraindications
- Hypersensitivity to Sofosbuvir or any component of the formulation.
- Monotherapy with Sofosbuvir is not recommended.
Drug Interactions
Amiodarone
Risk of severe symptomatic bradycardia, especially when co-administered with other DAAs (e.g., daclatasvir, ledipasvir, velpatasvir).
P-gp Inducers (e.g., Rifampin, St. John's Wort)
May significantly decrease Sofosbuvir plasma concentrations, leading to reduced therapeutic effect. Coadministration is not recommended.
Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital
May decrease Sofosbuvir concentrations.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management involves general supportive measures, including monitoring vital signs and observing for clinical status. Sofosbuvir and its main metabolite are not efficiently removed by hemodialysis.
Pregnancy & Lactation
Pregnancy Category B (animal studies showed no harm, but human data limited). Use only if potential benefit justifies potential risk to the fetus. Lactation: Unknown if excreted in human milk; use with caution.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA (USA) and DGDA (Bangladesh)
Patent Status
Patent protected (original innovator), generics available through voluntary licensing
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials (e.g., NEUTRINO, FISSION, POSITRON, FUSION) have demonstrated high sustained virologic response rates across various HCV genotypes, often in combination regimens.
Lab Monitoring
- HCV RNA viral load (before, during, and after treatment)
- Liver function tests (ALT, AST, bilirubin) periodically
- Renal function (eGFR)
Doctor Notes
- Sofosbuvir must be used in combination with other DAAs; monotherapy is not effective.
- Screen all patients for HBV infection before initiating HCV treatment.
- Monitor patients on amiodarone for bradycardia if co-administering with Sofosbuvir-containing regimens.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop treatment early without consulting your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed and less than 18 hours have passed since the usual time, take it as soon as possible. If more than 18 hours have passed, skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.
Driving Precautions
May cause dizziness or fatigue. Patients should be advised not to drive or operate machinery if they experience these symptoms.
Lifestyle Advice
- Maintain a healthy diet and lifestyle.
- Avoid alcohol consumption during treatment as it can worsen liver damage.
- Regular exercise may improve overall health.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.