Xiva
Generic Name
Sofosbuvir
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xiva 400 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Sofosbuvir is a direct-acting antiviral medication used in combination with other antiviral agents to treat chronic hepatitis C virus (HCV) infection in adults and adolescents. It works by inhibiting the viral RNA polymerase essential for HCV replication.
Uses & Indications
Dosage
Adults
400 mg once daily, taken orally with or without food, in combination with other agents, for 8, 12, or 24 weeks depending on the specific regimen and patient characteristics.
Elderly
No dose adjustment is required for elderly patients.
Renal_impairment
Not recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease (ESRD) requiring dialysis due to increased exposure to the primary metabolite. No dose adjustment needed for mild or moderate renal impairment.
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 prodrug that is intracellularly metabolized to its pharmacologically active uridine analog triphosphate (GS-461203). This active metabolite acts as a chain terminator, inhibiting the HCV NS5B RNA-dependent RNA polymerase, which is crucial for viral replication.
Pharmacokinetics
Onset
Rapid reduction in HCV RNA levels observed within days of initiating treatment.
Excretion
Mainly via urine (approximately 80% as GS-331007), with a small amount excreted in feces and expired air.
Half life
Sofosbuvir: approximately 0.5 hours; major circulating metabolite (GS-331007): approximately 18–19 hours.
Absorption
Rapidly absorbed. Peak plasma concentration of sofosbuvir reached 0.5–2 hours post-dose. Peak plasma concentration of its major circulating metabolite (GS-331007) reached 2–4 hours post-dose.
Metabolism
Sofosbuvir is primarily metabolized in the liver. It undergoes initial hydrolysis of the carboxyl ester moiety followed by phosphoramidate cleavage to form the active nucleoside triphosphate (GS-461203). It is also metabolized to the inactive nucleoside metabolite (GS-331007).
Side Effects
Contraindications
- Hypersensitivity to sofosbuvir or any of its excipients.
- Coadministration with strong P-glycoprotein (P-gp) inducers (e.g., Rifampin, St. John's Wort) is not recommended due to reduced plasma concentrations and potential loss of efficacy.
Drug Interactions
Amiodarone
Increased risk of symptomatic bradycardia when co-administered with Sofosbuvir and another DAA (e.g., Daclatasvir, Ledipasvir, Velpatasvir). Concurrent use is not recommended.
Tenofovir Disoproxil Fumarate (TDF)
Increased exposure to tenofovir. Monitor for tenofovir-associated adverse reactions, particularly renal dysfunction.
P-gp Inducers (e.g., Rifampin, Carbamazepine, Phenytoin, St. John's Wort)
May significantly decrease sofosbuvir plasma concentrations, leading to reduced therapeutic effect. Co-administration is not recommended.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management of overdose should consist of general supportive measures. Hemodialysis is unlikely to remove significant quantities of sofosbuvir or its active metabolite (GS-461203), but may be effective for GS-331007.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. If co-administered with Ribavirin, Ribavirin is contraindicated in pregnancy. It is not known whether Sofosbuvir and its metabolites are excreted in human milk; caution is advised during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, depending on the manufacturer.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved, DGDA Approved
Patent Status
Patent protected (originator), generics available (voluntary license)
WHO Essential Medicine
YesClinical Trials
Sofosbuvir has been extensively studied in various clinical trials (e.g., NEUTRINO, FUSION, POSITRON, VALENCE) demonstrating high rates of sustained virologic response (SVR) across different HCV genotypes and patient populations, including those with cirrhosis.
Lab Monitoring
- HCV RNA levels (viral load) at baseline, during, and after treatment to assess response.
- Liver function tests (ALT, AST, bilirubin) at baseline and periodically during treatment.
- Renal function (eGFR) at baseline and periodically, especially for patients with pre-existing renal impairment or those on tenofovir.
- Cardiac monitoring if co-administering with amiodarone.
Doctor Notes
- Prior to initiating therapy, ensure HCV genotyping and staging of liver disease.
- Review patient's complete medication list to identify potential drug interactions, especially with amiodarone and strong P-gp inducers.
- Monitor for signs and symptoms of bradycardia if amiodarone is co-administered with Sofosbuvir and another DAA.
- Advise patients about the importance of adherence to the prescribed regimen for optimal outcomes.
Patient Guidelines
- Take the medication exactly as prescribed by your doctor and complete the full course of treatment.
- Do not stop taking the medicine early, even if you feel better, without consulting your doctor.
- Inform your doctor about all other medications, herbal products, and supplements you are taking.
- Do not share this medication with others, as it may not be suitable for their condition.
Missed Dose Advice
If a dose is missed and it's within 18 hours of the scheduled 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 take a double dose.
Driving Precautions
Sofosbuvir can cause side effects like headache and fatigue, which might impair your ability to drive or operate machinery. Exercise caution until you know how this medicine affects you.
Lifestyle Advice
- Avoid alcohol consumption, as it can worsen liver disease.
- Maintain a healthy diet and lifestyle to support liver health.
- Practice safe sex to prevent the spread of HCV and other sexually transmitted infections.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.