Big Bear SODADX Sofosbuvir Velpatasvir 400mg/100mg

Product Information

• Product name: SODADX Sofosbuvir Velpatasvir 400mg/100mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Sofosbuvir Velpatasvir
• Current strength: 400mg/100mg
• SKU: BB-ITEM-14
• Site category: hepatitis C, other cancer

Product Summary

SODADX Sofosbuvir Velpatasvir 400mg/100mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Sofosbuvir Velpatasvir is the active ingredient used for this product page. Public prescribing information for Sofosbuvir Velpatasvir was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Sofosbuvir Velpatasvir is a fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir which are DAA agents against the hepatitis C virus .

Reference Indications

Sofosbuvir Velpatasvir is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have : genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Additional benefit of Sofosbuvir Velpatasvir over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.

Reference Dosage and Administration

Recommended dosage: One tablet (400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir) taken orally once daily with food.

With this 400mg/100mg product, that corresponds to 1 x 400mg/100mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Sofosbuvir Velpatasvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals (DAA) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated . WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See for complete boxed warning.

Common Adverse Reactions and Monitoring

Sofosbuvir Velpatasvir was studied in placebo- and active-controlled (sofosbuvir/velpatasvir) trials . The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2% for subjects who received Sofosbuvir Velpatasvir for 12 weeks. The side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs. Rash: In the POLARIS-1 and POLARIS-4 trials, rash occurred in less than 1% and 2% of subjects treated with Sofosbuvir Velpatasvir, respectively. Rash was reported in 1% of subjects treated with placebo in POLARIS-1 and was not reported by any subject taking sofosbuvir/velpatasvir in POLARIS-4.

Drug Interactions and Special Populations

P-gp inducers and/or moderate to strong CYP inducers (e.g., St. John’s wort, carbamazepine): May decrease concentrations of sofosbuvir, velpatasvir, and/or voxilaprevir. Use of Sofosbuvir Velpatasvir with P-gp inducers and/or moderate to strong CYP inducers is not recommended. ( 4 , 5.3 , 5.4 , 7 ) Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. Voxilaprevir is also a substrate of OATP1B1 and OATP1B3. Drugs that are inducers of P-gp and/or moderate to strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g., St.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Vosevi public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.