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Vosevi is a brand name for Sofosbuvir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg (see sections 4.2, 4.4 and 5.1). 3
Verbatim from this product's EMA label. Tap a section to expand.
Vosevi treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. 2). The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1. 1) DAA experienced patients* without cirrhosis or with compensated cirrhosis 12 weeks DAA: direct-acting antiviral agent * In clinical studies the DAA experienced patients had been exposed to combination regimens containing any of the following: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir, voxilaprevir (administered with sofosbuvir and velpatasvir for less than 12 weeks).
Missed dose If a dose of Vosevi is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet(s) as soon as possible and then patients should take the next dose at the usual time. If it is after 18 hours then patients should be instructed to wait and take the next dose of Vosevi at the usual time.
Patients should be instructed not to take a double dose of Vosevi. Patients should be instructed that if vomiting occurs within 4 hours of dosing an additional dose of Vosevi should be taken. 1). 2). Renal impairment No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment.
73 m2) and end stage renal disease (ESRD) requiring haemodialysis. Vosevi has not been studied in patients with ESRD requiring dialysis. 2). Hepatic impairment No dose adjustment of Vosevi is required for patients with mild hepatic impairment (Child-Pugh- Turcotte [CPT] Class A).
2). 4 Paediatric population The safety and efficacy of Vosevi in children aged less than 12 years and weighing less than 30 kg have not yet been established. No data are available. Method of administration For oral use. 2). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
1% for patients receiving sofosbuvir/velpatasvir/voxilaprevir for 8 weeks. There were no patients receiving sofosbuvir/velpatasvir/voxilaprevir for 12 weeks who permanently discontinued treatment due to adverse reactions in the Phase 2 and 3 pivotal clinical studies.
Tabulated summary of adverse reactions Assessment of adverse reactions for Vosevi is based on safety data from clinical studies and post- marketing experience. All adverse reactions are presented in Table 3. The adverse reactions are listed below by system organ class and frequency.
Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000) or very rare (< 1/10,000).
Table 3:
Adverse reactions identified with Vosevi Frequency Adverse reaction Nervous system disorders: Very common headache Gastrointestinal disorders: Very common diarrhoea, nausea Common abdominal pain, decreased appetite, vomiting Skin and subcutaneous tissue disorders: Common rash Uncommon angioedemaa Musculoskeletal and connective tissue disorders: Common myalgia Uncommon muscle spasm Laboratory investigations: Common total bilirubin increased a.
5). 5 x the upper limit of normal were observed in 4% of patients without cirrhosis and 10% of patients with compensated cirrhosis, due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir. Total bilirubin levels decreased after completing Vosevi treatment.
Patients with renal impairment The safety of sofosbuvir in a fixed dose combination with either ledipasvir or velpatasvir has been studied in 154 patients with ESRD requiring dialysis (Study 4062 and Study 4063). In this setting, 19 exposure of sofosbuvir metabolite GS-331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical studies.
Severe bradycardia and heart block Life-threatening cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone. Bradycardia has generally occurred within hours to days, but cases with a longer time to onset have been observed mostly up to 2 weeks after initiating HCV treatment.
Amiodarone should only be used in patients on Vosevi when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated. Should concomitant use of amiodarone be considered necessary, it is recommended that patients undergo cardiac monitoring in an in-patient setting for the first 48 hours of coadministration, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.
Due to the long half-life of amiodarone, cardiac monitoring as outlined above should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Vosevi. All patients with concurrent or recent use of amiodarone should be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
HCV/HBV co-infection There are no data on the use of Vosevi in patients with HCV/hepatitis B virus (HBV) co-infection. Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with DAAs. HBV screening should be performed in all patients before initiation of treatment.
HCV/HBV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines. 73 m2) and ESRD requiring haemodialysis. 2). Hepatic impairment No dose adjustment of Vosevi is required for patients with mild hepatic impairment (CPT Class A).
2). Liver transplant patients The safety and efficacy of Vosevi in the treatment of HCV infection in patients who are post-liver transplant have not been assessed. 2), should be guided by an assessment of the potential benefits and risks for the individual patient.
1. g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. 5). 5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sofosbuvir in European Union.
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In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients. Paediatric population The safety assessment of Vosevi in paediatric patients aged 12 years and older is based on data from 21 DAA-naïve patients with genotype 1, 2, 3, or 4 HCV infection (without cirrhosis) who were treated with Vosevi for 8 weeks in a Phase 2, open-label clinical study (study 1175).
The adverse reactions observed were consistent with those observed in clinical studies of Vosevi in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir, velpatasvir and/or voxilaprevir plasma concentrations leading to reduced therapeutic effect of Vosevi. 5). g. ciclosporin) may substantially increase voxilaprevir plasma concentrations, the safety of which has not been established.
5). Use with certain HIV antiretroviral regimens Vosevi has been shown to increase tenofovir exposure when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
The safety of tenofovir disoproxil fumarate in the setting of Vosevi and a pharmacokinetic enhancer has not been established. g. darunavir) should be considered, particularly in patients at increased risk of renal dysfunction. Patients receiving Vosevi concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions.
Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Use in diabetic patients Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment. Glucose levels of diabetic patients initiating DAA therapy should be closely monitored, particularly within the first 3 months, and their diabetic treatment modified when necessary.
The physician in charge of the diabetic care of the patient should be informed when DAA therapy is initiated. 6 Excipients Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.