Velpanex
Generic Name
Sofosbuvir + Velpatasvir
Manufacturer
Incepta 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 fixed-dose combination of sofosbuvir and velpatasvir, used for the treatment of chronic hepatitis C virus (HCV) infection across all genotypes (1-6) in adults. It is effective in patients with or without compensated cirrhosis and, in combination with ribavirin, for those with decompensated cirrhosis.
Uses & Indications
Dosage
Adults
One tablet (sofosbuvir 400 mg/velpatasvir 100 mg) orally once daily for 12 weeks. For decompensated cirrhosis, administer with ribavirin for 12 or 24 weeks depending on severity.
Elderly
No dose adjustment is required for elderly patients.
Renal_impairment
No dose adjustment 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) due to lack of data.
How to Take
Take orally once daily with or without food. Swallow the tablet whole; do not chew or crush it.
Mechanism of Action
Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor, preventing viral RNA replication. Velpatasvir is an HCV NS5A inhibitor, disrupting viral replication, assembly, and secretion. The combination provides broad-spectrum antiviral activity against various HCV genotypes.
Pharmacokinetics
Onset
Antiviral effects begin rapidly within hours of first dose.
Excretion
Sofosbuvir active metabolite is primarily excreted renally. Velpatasvir is primarily excreted in feces.
Half life
Sofosbuvir active metabolite (GS-331007) half-life is approximately 18 hours. Velpatasvir half-life is approximately 15 hours.
Absorption
Sofosbuvir is rapidly absorbed, reaching peak plasma concentration within 0.5-2 hours. Velpatasvir is absorbed more slowly, with peak concentration at 3 hours.
Metabolism
Sofosbuvir is metabolized primarily in the liver to its pharmacologically active nucleoside analog triphosphate. Velpatasvir is primarily metabolized by CYP3A4, CYP2B6, and CYP2C8.
Side Effects
Contraindications
- Hypersensitivity to sofosbuvir, velpatasvir, or any component of the tablet.
- Co-administration with strong P-glycoprotein (P-gp) inducers or moderate/strong CYP inducers (e.g., rifampin, St. John's Wort, carbamazepine, phenytoin) due to reduced plasma concentrations and potential loss of efficacy.
Drug Interactions
Rifampin
Strong inducer of P-gp and CYP, significantly reduces sofosbuvir and velpatasvir levels. Co-administration is contraindicated.
Amiodarone
Serious symptomatic bradycardia and cardiac arrest have been reported. Co-administration is not recommended. If unavoidable, monitor cardiac status.
St. John's Wort
Strong inducer of P-gp and CYP, significantly reduces sofosbuvir and velpatasvir levels. Co-administration is contraindicated.
Proton Pump Inhibitors (PPIs)
Omeprazole, lansoprazole, pantoprazole: Can significantly decrease velpatasvir plasma concentration. Should be taken with food, 4 hours prior to PPI. Use an H2-receptor antagonist instead, or if PPI is essential, take Velpanex with food, 4 hours before the PPI.
Anticonvulsants (e.g., Carbamazepine, Phenytoin)
Can significantly decrease sofosbuvir and velpatasvir plasma concentrations, leading to reduced therapeutic effect. Co-administration is contraindicated.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Velpanex overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical condition. Hemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir (GS-331007), but not velpatasvir.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. It is unknown if sofosbuvir or velpatasvir are excreted in human milk. Breastfeeding is not recommended due to potential risks.
Side Effects
Contraindications
- Hypersensitivity to sofosbuvir, velpatasvir, or any component of the tablet.
- Co-administration with strong P-glycoprotein (P-gp) inducers or moderate/strong CYP inducers (e.g., rifampin, St. John's Wort, carbamazepine, phenytoin) due to reduced plasma concentrations and potential loss of efficacy.
Drug Interactions
Rifampin
Strong inducer of P-gp and CYP, significantly reduces sofosbuvir and velpatasvir levels. Co-administration is contraindicated.
Amiodarone
Serious symptomatic bradycardia and cardiac arrest have been reported. Co-administration is not recommended. If unavoidable, monitor cardiac status.
St. John's Wort
Strong inducer of P-gp and CYP, significantly reduces sofosbuvir and velpatasvir levels. Co-administration is contraindicated.
Proton Pump Inhibitors (PPIs)
Omeprazole, lansoprazole, pantoprazole: Can significantly decrease velpatasvir plasma concentration. Should be taken with food, 4 hours prior to PPI. Use an H2-receptor antagonist instead, or if PPI is essential, take Velpanex with food, 4 hours before the PPI.
Anticonvulsants (e.g., Carbamazepine, Phenytoin)
Can significantly decrease sofosbuvir and velpatasvir plasma concentrations, leading to reduced therapeutic effect. Co-administration is contraindicated.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Velpanex overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical condition. Hemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir (GS-331007), but not velpatasvir.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. It is unknown if sofosbuvir or velpatasvir are excreted in human milk. Breastfeeding is not recommended due to potential risks.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA for original combination, DGDA for generics)
Patent Status
Generic available (original patent holder: Gilead Sciences)
WHO Essential Medicine
YesClinical Trials
The efficacy and safety of sofosbuvir/velpatasvir were established in multiple Phase 3 clinical trials (e.g., ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4) involving patients with various HCV genotypes, including those with cirrhosis.
Lab Monitoring
- HCV RNA levels (before, during, and after treatment to assess response)
- Liver function tests (ALT, AST, bilirubin) regularly
- Renal function (eGFR) periodically
- HBV status (HBsAg, anti-HBc) before initiating therapy and monitor for reactivation if co-infected
Doctor Notes
- Prioritize HBV screening for all patients before initiating Velpanex.
- Review all concomitant medications to identify potential drug interactions, especially P-gp and CYP inducers.
- For patients with decompensated cirrhosis, ensure appropriate ribavirin dosing and monitor for adverse effects.
Patient Guidelines
- Complete the entire course of treatment as prescribed, even if you feel better.
- Do not stop treatment without consulting your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any new or worsening symptoms, especially signs of liver problems or heart rate changes.
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 regular time. Do not take a double dose to make up for a missed one.
Driving Precautions
Some patients may experience headache, fatigue, or dizziness while taking Velpanex. If these occur, caution should be exercised when driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption, as it can worsen liver disease.
- Maintain a healthy diet and regular exercise as advised by your healthcare provider.
- Follow up with your doctor for scheduled appointments and lab tests.
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