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SOVALDI is a brand name for Sofosbuvir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SOVALDI is indicated for the treatment of genotype 1, 2, 3, or 4 chronic hepatitis C virus (CHC) infection as a component of a combination antiviral treatment regimen. The following points should be considered when initiating treatment with SOVALDI: SOVALDI must not be administered as monotherapy (see 7 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
). Treatment response varies based on baseline host and viral factors. Patients Awaiting Liver Transplantation Efficacy with SOVALDI + ribavirin (RBV) regimen has been established in patients with HCV genotype 1, 2, 3 or 4 infection awaiting liver transplantation with hepatocellular carcinoma (HCC) meeting Milan criteria (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Patients Co-infected with Human Immunodeficiency Virus (HIV-1) Efficacy with SOVALDI + RBV regimen has been established in treatment-naïve CHC patients with HCV genotype 1 and in CHC patients with HCV genotype 2 or 3 regardless of treatment experience.
Clinical data is not available for treatment-experienced HCV genotype 1 patients or HCV genotype 4 patients (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS). 1 Pediatrics (< 18 years of age) Safety and effectiveness in pediatric patients have not been established (see 7 WARNINGS AND PRECAUTIONS).
Therefore, Health Canada has not authorized an indication for pediatric use in patients less than 18 years of age. 2 Geriatrics (> 65 years of age) Clinical studies of SOVALDI involving patients aged 65 and over showed similar treatment response rates to that of younger subjects across treatment groups.
In general, caution should be exercised when administering SOVALDI in elderly patients, reflecting the greater frequency of anemia, decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy (see 7 WARNINGS AND PRECAUTIONS).
2 CONTRAINDICATIONS SOVALDI is contraindicated in patients with known hypersensitivity to any of the components of the product. For a complete listing, see the
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, General). Treatment regimen and duration are dependent on both viral genotype and patient population (see 4 DOSAGE AND ADMINISTRATION). Treatment response varies based on baseline host and viral factors. Patients Awaiting Liver Transplantation Efficacy with SOVALDI + ribavirin (RBV) regimen has been established in patients with HCV genotype 1, 2, 3 or 4 infection awaiting liver transplantation with hepatocellular carcinoma (HCC) meeting Milan criteria (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Patients Co-infected with Human Immunodeficiency Virus (HIV-1) Efficacy with SOVALDI + RBV regimen has been established in treatment-naïve CHC patients with HCV genotype 1 and in CHC patients with HCV genotype 2 or 3 regardless of treatment experience.
Clinical data is not available for treatment-experienced HCV genotype 1 patients or HCV genotype 4 patients (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS). 1 Pediatrics (< 18 years of age) Safety and effectiveness in pediatric patients have not been established (see 7 WARNINGS AND PRECAUTIONS).
Therefore, Health Canada has not authorized an indication for pediatric use in patients less than 18 years of age. 2 Geriatrics (> 65 years of age) Clinical studies of SOVALDI involving patients aged 65 and over showed similar treatment response rates to that of younger subjects across treatment groups.
In general, caution should be exercised when administering SOVALDI in elderly patients, reflecting the greater frequency of anemia, decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy (see 7 WARNINGS AND PRECAUTIONS).
2 CONTRAINDICATIONS SOVALDI is contraindicated in patients with known hypersensitivity to any of the components of the product. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.
SOVALDI is contraindicated in patients with known hypersensitivity to any of the components of the product. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph. When SOVALDI is used in combination with peginterferon alfa/ribavirin or ribavirin, the contraindications applicable to those agents are applicable to combination therapies.
Refer to the Product Monographs of peginterferon alfa and ribavirin for a list of their contraindications. 1 Special Populations).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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When SOVALDI is used in combination with peginterferon alfa/ribavirin or ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Refer to the Product Monographs of peginterferon alfa and ribavirin for a list of their contraindications.
1 Special Populations). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Potential for Hepatitis B Virus (HBV) Reactivation Screen all patients for evidence of current or prior HBV infection before initiating SOVALDI treatment.
Cases of HBV reactivation, including those resulting in fulminant hepatitis, hepatic failure, and death, have been reported during HCV treatment and/or post -treatment with regimens containing direct acting antivirals (DAAs) in patients co-infected with HBV (see 7 WARNINGS AND PRECAUTIONS, Potential for HBV Reactivation).
1 Dosing Considerations SOVALDI must only be used in combination with either pegylated interferon and ribavirin (genotypes 1 and 4, respectively), or ribavirin alone (genotypes 2 and 3, respectively). 3 Pharmacokinetics). The recommended dose and treatment duration for SOVALDI combination therapy is provided in Table 1.
Table 1. Recommended Dose and Treatment Durationa for SOVALDI Combination Therapy in HCV Mono-infected and HIV-1 Co-infected Patients Duration SOVALDI Dose (daily) Peginterferon alfa Dose Ribavirin Dose (daily) Patients with genotype 1 or 4 CHC 12 weeks 400 mg Refer to peginterferon alfa PM Refer to PM containing ribavirin information Patients with genotype 2 CHC 12 weeks NA <75 kg = 1000 mgb ≥75 kg = 1200 mgbPatients with genotype 3 CHC 24 weeks NA = not applicable; PM = Product Monograph a.
Treatment duration is fixed and is not guided by subjects' HCV RNA levels (ie, no response guided therapy). b. The daily dose of ribavirin is administered orally in tw o divided doses w ith food. Product Monograph SOVALDI (sofosbuvir) tablets Page 6 of 54 SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for treatment naïve and non-cirrhotic treatment experienced CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen (see 14 CLINICAL TRIALS).
Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient. Dose Modification Dose reduction of SOVALDI is not recommended. Genotype 1 and 4 If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced accordingly or discontinued if necessary.
If discontinuation is necessary, SOVALDI must also be discontinued (see 4 DOSAGE AND ADMINISTRATION, Discontinuation of Dosing). Refer to the Product Monographs for peginterferon alfa and ribavirin for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.
Genotype 2 and 3 If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if necessary, until the adverse reaction abates or decreases in severity. If discontinuation is necessary, SOVALDI must also be discontinued (see 4 DOSAGE AND ADMINISTRATION, Discontinuation of Dosing).
Table 2 provides guidelines for dose modifications and discontinuation based on the patient’s hemoglobin concentration and cardiac status. Product Monograph SOVALDI (sofosbuvir) tablets Page 7 of 54 Table 2. Ribavirin Dose […]