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Epclusa is a brand name for Sofosbuvir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. 2). The recommended dose of Epclusa in paediatric patients aged 3 years and above is based on weight as detailed in Table 3.
A granule formulation of Epclusa is available for the treatment of chronic HCV infection in paediatric patients aged 3 years and above having difficulty swallowing film-coated tablets. 5 mg granules. 4). When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
The following dosing is recommended for adults where ribavirin is divided in two daily doses and given with food: Table 2: Guidance for ribavirin dosing when administered with Epclusa to adults with decompensated cirrhosis Adult patient Ribavirin dose Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg CPT Class C cirrhosis pre-transplant CPT Class B or C post-transplant Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
If the starting dose is not well tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels If ribavirin is used in genotype 3 infected adult patients with compensated cirrhosis (pre- or post- transplant) the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for adult patients weighing < 75 kg and 1,200 mg for adult patients weighing ≥ 75 kg).
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Table 3:
Recommended treatment and duration for paediatric patients aged 3 to < 18 Years regardless of HCV genotype using Epclusa Tablets* Body weight (kg) Dosing of Epclusa tablets Sofosbuvir/Velpatasvir daily dose Recommended treatment regimen ≥ 30 one 400 mg/100 mg tablet once daily or two 200 mg/50 mg tablets once daily 400 mg/100 mg per day Epclusa for 12 weeks 17 to < 30 one 200 mg/50 mg tablet once daily 200 mg/50 mg per day *Epclusa is also available as granules for paediatric patients with chronic HCV infection aged 3 years and above.
Summary of the safety profile The safety profile of Epclusa has been determined in pooled Phase 3 clinical studies of patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and in the postmarketing setting. No adverse drug reactions to Epclusa were identified from clinical studies.
4). 16 Tabulated summary of adverse reactions Assessment of adverse reactions for Epclusa is based on safety data from clinical studies and postmarketing experience. All adverse reactions are presented in Table
Epclusa should not be administered concurrently with other medicinal products containing sofosbuvir. 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 5 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 Epclusa 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 co-administration, 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 Epclusa. 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 (hepatitis B virus) co-infection Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral medicinal products. HBV screening should be performed in all patients before initiation of treatment.
HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines. Patients who have previously failed therapy with an NS5A-containing regimen There are no clinical data to support the efficacy of sofosbuvir/velpatasvir for the treatment of patients who have failed treatment with a regimen containing another NS5A inhibitor.
1. Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. 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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5 mg granules. 4 Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Epclusa should be taken. 1). If a dose of Epclusa is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet 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 Epclusa at the usual time. Patients should be instructed not to take a double dose of Epclusa. 4). 2). Renal impairment No dose adjustment of Epclusa is required for patients with mild or moderate renal impairment.
73 m2) and end stage renal disease (ESRD) requiring haemodialysis. 2). 2). 1). Paediatric population The safety and efficacy of Epclusa in children aged less than 3 years have not been established. No data are available. Method of administration For oral use.
2). Due to the bitter taste, it is recommended that film-coated tablets are not chewed or crushed.
However, on the basis of NS5A resistance associated variants (RAVs) typically seen in patients who have failed therapy with other NS5A inhibitor containing regimens, the in vitro pharmacology of velpatasvir, and the outcomes of sofosbuvir/velpatasvir treatment in NS5A-naïve patients with baseline NS5A RAVs enrolled into the ASTRAL-studies, treatment with Epclusa + RBV for 24 weeks can be considered for patients who have failed therapy on an NS5A-containing regimen and who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
73 m2) and ESRD requiring haemodialysis. 2). 2). g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa. 5). Use with certain HIV antiretroviral regimens Epclusa has been shown to increase tenofovir exposure, especially 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 Epclusa and a pharmacokinetic 6 enhancer has not been established. g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Patients receiving Epclusa 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 direct-acting antiviral treatment. Glucose levels of diabetic patients initiating direct-acting antiviral 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 direct-acting antiviral therapy is initiated. 1). Liver transplant patients The safety and efficacy of Epclusa 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. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.