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VOSEVI 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: VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment VOSEVI is a single tablet regimen. No dosage adjustments are possible for VOSEVI. 3 Pharmacokinetics, Effects of Food). The recommended treatment duration for VOSEVI is provided in Table 2. Table 2.
Recommended Treatment Regimen Genotype Patients Previously Treated with an HCV Regimen Containing: VOSEVI Duration 1, 2, 3, 4, 5, or 6 An NS5A inhibitora 12 weeks 1, 2, 3, or 4 Sofosbuvir without an NS5A inhibitorb 12 weeks a. In clinical trials, prior NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir.
b. In clinical trials, prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir). Special Populations Pediatrics (< 18 Years of age) VOSEVI is not indicated for use in pediatric patients less than 18 years of age.
Geriatrics (≥ 65 years of age) No dose adjustment is warranted for elderly patients (see 10 CLINICAL PHARMACOLOGY). Product Monograph VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) tablets Page 6 of 57 Hepatic Impairment VOSEVI is not recommended in patients with moderate or severe hepatic impairment (Child- Pugh B or C).
No dose adjustment of VOSEVI is required for patients with mild hepatic impairment (Child-Pugh A) (see 10 CLINICAL PHARMACOLOGY). Renal Impairment No dose adjustment of VOSEVI is required for patients with any stage of renal impairment, including end-stage renal disease (ESRD) requiring dialysis based on extrapolation of relevant clinical data (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
5 Missed Dose If a patient misses a dose of VOSEVI within 18 hours of the time it is usually taken, the patient should take VOSEVI as soon as possible, and then take the next dose of VOSEVI at the regularly scheduled time. If a patient misses a dose of VOSEVI and it is after 18 hours of the time it is usually taken, the patient should not take the missed dose, but resume the usual dosing schedule.
A double dose of VOSEVI must not be taken. If a patient vomits less than 4 hours after taking a dose of VOSEVI, the patient should take another dose of VOSEVI. If a patient vomits more than 4 hours after taking a dose of VOSEVI, the patient should take the next dose at the regularly scheduled time.
5 Post-Market Adverse Reactions, and
, Potential for HBV Reactivation). 2 Recommended Dose and Dosage Adjustment VOSEVI is a single tablet regimen. No dosage adjustments are possible for VOSEVI. 3 Pharmacokinetics, Effects of Food). The recommended treatment duration for VOSEVI is provided in Table 2.
Table 2. Recommended Treatment Regimen Genotype Patients Previously Treated with an HCV Regimen Containing: VOSEVI Duration 1, 2, 3, 4, 5, or 6 An NS5A inhibitora 12 weeks 1, 2, 3, or 4 Sofosbuvir without an NS5A inhibitorb 12 weeks a.
In clinical trials, prior NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir. b. In clinical trials, prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir).
Special Populations Pediatrics (< 18 Years of age) VOSEVI is not indicated for use in pediatric patients less than 18 years of age. Geriatrics (≥ 65 years of age) No dose adjustment is warranted for elderly patients (see 10 CLINICAL PHARMACOLOGY).
Product Monograph VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) tablets Page 6 of 57 Hepatic Impairment VOSEVI is not recommended in patients with moderate or severe hepatic impairment (Child- Pugh B or C). No dose adjustment of VOSEVI is required for patients with mild hepatic impairment (Child-Pugh A) (see 10 CLINICAL PHARMACOLOGY).
Renal Impairment No dose adjustment of VOSEVI is required for patients with any stage of renal impairment, including end-stage renal disease (ESRD) requiring dialysis based on extrapolation of relevant clinical data (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
5 Missed Dose If a patient misses a dose of VOSEVI within 18 hours of the time it is usually taken, the patient should take VOSEVI as soon as possible, and then take the next dose of VOSEVI at the regularly scheduled time. If a patient misses a dose of VOSEVI and it is after 18 hours of the time it is usually taken, the patient should not take the missed dose, but resume the usual dosing schedule.
VOSEVI is contraindicated in patients with known hypersensitivity to any of the components of the product. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Table 1 lists drugs which are contraindicated with VOSEVI (see 9 DRUG INTERACTIONS).
Table 1.
Drugs that are Contraindicated with VOSEVI Drug Class:
Drug Name Effect on Concentration Mechanism of Action Clinical Comment Anticoagulants: dabigatran etexilate ↑ dabigatran P-gp inhibition Increased risk of bleeding. Anticonvulsants: phenobarbital, phenytoin sofosbuvir velpatasvir voxilaprevir Induction of P-gp and CYP450 Risk of loss of therapeutic effect of VOSEVI.
Antimycobacterials: rifampin sofosbuvir velpatasvir voxilaprevir Induction of P-gp and CYPs Risk of loss of therapeutic effect of VOSEVI.
Herbal products:
St. John’s wort (Hypericum perforatum) sofosbuvir velpatasvir voxilaprevir Induction of P-gp and CYP450 Risk of loss of therapeutic effect of VOSEVI. HMG-CoA reductase inhibitors: rosuvastatin rosuvastatin BCRP and OATP1B inhibition Increased risk of statin- related myopathy, including rhabdomyolysis.
Product Monograph VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) tablets Page 5 of 57
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sofosbuvir in Canada.
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A double dose of VOSEVI must not be taken. If a patient vomits less than 4 hours after taking a dose of VOSEVI, the patient should take another dose of VOSEVI. If a patient vomits more than 4 hours after taking a dose of VOSEVI, the patient should take the next dose at the regularly scheduled time.
5 OVERDOSAGE For management of a suspected drug overdose, contact your regional poison control centre. Administration of activated charcoal may be used to aid in the removal of unabsorbed active substance. General supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient are recommended.
No specific antidote is available for overdose with VOSEVI. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with VOSEVI consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Hemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%. Hemodialysis is unlikely to result in significant removal of velpatasvir or voxilaprevir since velpatasvir and voxilaprevir are highly bound to plasma protein.
The highest documented doses of sofosbuvir, velpatasvir, and voxilaprevir were single doses of 1200 mg, 500 mg, and 900 mg, respectively. In healthy volunteer studies with sofosbuvir and velpatasvir, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups.
The most common adverse events in subjects receiving voxilaprevir 900 mg were diarrhea (34%), vomiting (19%), and nausea (17%). The effects of higher doses/exposures are not known. Product Monograph VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) tablets Page 7 of 57 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3.
Dosage Forms, Strengths, Composition and Packaging VOSEVI is a single tablet regimen containing sofosbuvir, velpatasvir, and voxilaprevir for oral administration. VOSEVI is available as a beige-colored, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “ 3 ” on the other side of the tablet.
Each bottle contains 28 tablets, a polyester coil and silica gel desiccant and is closed with a child-resistant closure. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Treatment with VOSEVI should be initiated and monitored by a physician experienced in the management of chronic HCV infection.
Data to support the treatment of patients infected with HCV genotype 5 or genotype 6 who have failed prior therapy of an HCV regimen containing an NS5A inhibitor are limited. The indication for treatment of these patients is based on extrapolation of relevant clinical and in vitro data (see 14 CLINICAL TRIALS and 15 MICROBIOLOGY).
No clinical data are available to support the treatment of HCV patients with genotype 5 or genotype 6 infection who have failed prior therapy of an HCV regimen containing sofosbuvir without an NS5A inhibitor (see 14 CLINICAL TRIALS).
VOSEVI should not be administered concurrently with other medicinal products containing sofosbuvir. Use with P-gp Inducers and/or Moderate to Strong Inducers of CYP Medicinal products that are inducers of P-glycoprotein (P-gp) and/or moderate to strong inducers of […]