Velpanex
Generic Name
Sofosbuvir 400 mg + Velpatasvir 100 mg
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| velpanex 400 mg tablet | ৳ 1,000.00 | N/A |
Description
Overview of the medicine
Velpanex is a combination medicine containing Sofosbuvir and Velpatasvir, used to treat chronic Hepatitis C virus (HCV) infection of all genotypes (1-6). It is a direct-acting antiviral (DAA) that works by inhibiting viral replication.
Uses & Indications
Dosage
Adults
One tablet (sofosbuvir 400 mg/velpatasvir 100 mg) taken orally once daily for 12 weeks. With or without ribavirin for certain populations (e.g., decompensated cirrhosis).
Elderly
No dose adjustment is required for elderly patients.
Renal_impairment
No dose adjustment is required for patients with mild or moderate renal impairment (eGFR ≥30 mL/min/1.73 m2). Not recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease (ESRD).
How to Take
Take the tablet orally once daily with or without food. Swallow the tablet whole. Do not chew or crush.
Mechanism of Action
Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor that prevents HCV RNA replication. Velpatasvir is an NS5A inhibitor that is essential for HCV RNA replication and virion assembly.
Pharmacokinetics
Onset
Rapid antiviral effect, leading to a sustained virologic response (SVR) typically after 12 weeks of treatment.
Excretion
Sofosbuvir (as metabolites) is primarily excreted via urine (~80%), with a small amount in feces and expired air. Velpatasvir is primarily excreted via feces (~94%) with minimal renal excretion.
Half life
Sofosbuvir: ~0.5 hours (active metabolite GS-331007: ~27 hours); Velpatasvir: ~15 hours.
Absorption
Both sofosbuvir and velpatasvir are rapidly absorbed after oral administration, with peak plasma concentrations occurring within 0.5-2 hours for sofosbuvir and 3 hours for velpatasvir.
Metabolism
Sofosbuvir is extensively metabolized in the liver to the pharmacologically active nucleoside analog triphosphate (GS-461203) and then to the inactive metabolite (GS-331007). Velpatasvir is metabolized by CYP3A4, CYP2B6, and CYP2C8.
Side Effects
Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Co-administration with strong P-gp inducers and/or strong CYP inducers (e.g., rifampin, St. John's Wort) due to potential for significant reduction in sofosbuvir and velpatasvir plasma concentrations.
Drug Interactions
Amiodarone
Increased risk of severe symptomatic bradycardia. Co-administration is not recommended.
Rosuvastatin
Increased plasma concentration of rosuvastatin, requiring dose reduction of rosuvastatin.
Antacids, PPIs, H2 blockers
May decrease velpatasvir absorption; separation of administration or dose adjustments may be necessary.
P-gp/CYP inducers (e.g., rifampin, carbamazepine, St. John's Wort)
May significantly decrease plasma concentrations of sofosbuvir and velpatasvir, leading to reduced therapeutic effect.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
No specific antidote is available for overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Hemodialysis can remove the predominant circulating metabolite of sofosbuvir (GS-331007) but not velpatasvir.
Pregnancy & Lactation
Pregnancy Category B (older system). Limited data on use in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if sofosbuvir or velpatasvir and its metabolites are excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Velpanex therapy.
Side Effects
Contraindications
- Hypersensitivity to the active substances or to any of the excipients.
- Co-administration with strong P-gp inducers and/or strong CYP inducers (e.g., rifampin, St. John's Wort) due to potential for significant reduction in sofosbuvir and velpatasvir plasma concentrations.
Drug Interactions
Amiodarone
Increased risk of severe symptomatic bradycardia. Co-administration is not recommended.
Rosuvastatin
Increased plasma concentration of rosuvastatin, requiring dose reduction of rosuvastatin.
Antacids, PPIs, H2 blockers
May decrease velpatasvir absorption; separation of administration or dose adjustments may be necessary.
P-gp/CYP inducers (e.g., rifampin, carbamazepine, St. John's Wort)
May significantly decrease plasma concentrations of sofosbuvir and velpatasvir, leading to reduced therapeutic effect.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
No specific antidote is available for overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Hemodialysis can remove the predominant circulating metabolite of sofosbuvir (GS-331007) but not velpatasvir.
Pregnancy & Lactation
Pregnancy Category B (older system). Limited data on use in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if sofosbuvir or velpatasvir and its metabolites are excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Velpanex therapy.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved (FDA, DGDA for generics)
Patent Status
Patented (original), generics available
WHO Essential Medicine
YesClinical Trials
The efficacy and safety of Sofosbuvir/Velpatasvir were established in multiple Phase 3 clinical trials (ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4) involving patients with various HCV genotypes, including those with compensated and decompensated cirrhosis, and HIV/HCV co-infection, demonstrating high SVR rates.
Lab Monitoring
- Baseline and on-treatment HCV RNA levels
- Liver function tests (ALT, AST, bilirubin) prior to and during treatment
- Renal function (eGFR) if concomitant medications require monitoring or if renal impairment is suspected.
Doctor Notes
- Emphasize the critical importance of treatment adherence for achieving SVR.
- Carefully review concomitant medications for potential drug interactions, especially with amiodarone.
- Not recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor. Do not stop taking it early, even if you feel better.
- Inform your doctor about all other medications, herbal supplements, and over-the-counter drugs you are taking.
- Do not take antacids within 4 hours before or after taking Velpanex.
Missed Dose Advice
If a dose is missed and it has been less than 18 hours since the scheduled time, take it as soon as possible. If it has been more than 18 hours, skip the missed dose and take the next dose at the regularly scheduled time. Do not take a double dose.
Driving Precautions
This medicine may cause dizziness or fatigue. If you experience these symptoms, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid alcohol consumption, as it can further damage the liver.
- Maintain a healthy diet and lifestyle to support liver health.
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