To comply with Canadian International Pharmacy Association regulations you are permitted to order a 3-month supply or the closest package size available based on your personal prescription. Epclusa (sofosbuvir dan velpatasvir) adalah obat kombinasi dosis tetap yang digunakan untuk pengobatan infeksi hepatitis C (HCV) kronis. In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative adult patients with severe renal impairment. Erfahren Sie mehr über Nebenwirkungen, Warnhinweise, Dosierung und mehr. Will you have Loss Of Consciousness with Vitamin D3? The study is based on sofosbuvir; velpatasvir and phenytoin sodium (the active ingredients of Epclusa and Dilantin, respectively), and Epclusa and Dilantin (the brand names). Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively. 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. Last updated on July 24, 2020. A coagulation test helps to identify patients with an increased bleeding risk due to increased dabigatran exposure. Find everything you need to know about Epclusa (Sofosbuvir And Velpatasvir), including what it is used for, warnings, reviews, side effects, and interactions. Does Epclusa Interact with other Medications? The ribavirin dose was weight-based (1,000 mg daily administered in two divided doses for patients < 75 kg and 1,200 mg for those ≥ 75 kg) and administered in two divided doses when used in combination with sofosbuvir in the ASTRAL-2 and ASTRAL-3 studies or in combination with Epclusa in the ASTRAL-4 study. 52 Reviews. The cure rate was 95% for people taking Epclusa for 12 weeks compared to 80% for those taking sofosbuvir plus ribavirin for 24 weeks. The following should also be avoided when using Epclusa: 1. – Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. The pharmacokinetics of sofosbuvir, GS-331007 and velpatasvir in paediatric patients aged less than 6 years and weighing <17 kg have not been established (see section 4.2). Safety and efficacy of Epclusa has not been assessed in patients with CPT Class C cirrhosis (see sections 4.8 and 5.1). The overall SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed Epclusa treatment and relapsed and two did not meet virologic failure criteria. Coadministration of Epclusa is not recommended with topotecan or proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir. Impact of DAA therapy on drugs metabolized by the liver. In this setting, exposure of sofosbuvir metabolite GS-331007 was 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials. Your Use if Checked Off by Your Provider. Epclusa has active ingredients of sofosbuvir; velpatasvir. There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir or Epclusa in pregnant women. The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma. The pharmacokinetic properties of sofosbuvir, GS-331007 and velpatasvir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration of Epclusa, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 1 hour post-dose. This information is intended for use by health professionals. Pharmacotherapeutic group: Antivirals for systemic use; Direct acting antiviral, ATC code: J05AP55. Clinical studies in patients with decompensated cirrhosis Life-threatening cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone. It rots your teeth! Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and “7916” on the other side. It is often used in epilepsy. Epclusa is suitable for both previously untreated (treatment-naïve) patients, as well as those with partial or no response to prior HCV therapy (treatment-experienced). Topotecan - Epclusa may increase topotecan levels. b Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing. This will allow quick identification of new safety information. For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin. The pharmacokinetics of sofosbuvir was studied in HCV negative adult patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir, relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2). Baseline RAVs had no relevant impact on SVR12 rates in patients infected with genotype 1, 2, 4, 5 and 6 HCV, as summarised in Table 8. The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway. Co-administration will significantly decrease sofosbuvir or velpatasvir plasma concentrations and could result in loss of efficacy of Epclusa (see section 4.5). SVR12 for selected subgroups are presented in Table 15. No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007 or velpatasvir. If you miss a dose, take the missed dose as soon as you remember the same day. A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Epclusa compared to subjects with normal renal function, as described in the text below, are provided in Table 20. Table 13 presents the SVR12 for the ASTRAL-2 study. This medication is a combination of sofosbuvir and velpatasvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It is the first hepatitis C medication that can successfully treat all six genotypes. The following chart provides information regarding potentially significant drug interactions with Epclusa (the table is not all-inclusive). 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. Sofosbuvir is converted to an active form in the body before it is effective. Epclusa (Sofosbuvir und Velpatasvir) ist ein Kombinationspräparat mit fester Dosis, das zur Behandlung einer chronischen Hepatitis C (HCV) -Infektion verwendet wird. M… Continue typing to refine. Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered dose. Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine administered with a ritonavir boosted protease inhibitor (atazanavir, darunavir, or lopinavir), rilpivirine, raltegravir or emtricitabine/tenofovir disoproxil fumarate /elvitegravir/cobicistat. These medications are not usually taken together. Epclusa is contraindicated with carbamazepine (see section 4.3). Die beiden Medikamente, aus denen Epclusa besteht, blockieren sowohl ein Enzym (RNA-Polymerase) als auch ein Protein (NS5A), das für die Replikation des Virus von entscheidender Bedeutung ist. This is due to liver function changes during treatment with Epclusa. Epclusa (Sofosbuvir und Velpatasvir) ist ein Kombinationspräparat mit fester Dosis, das bei der Behandlung der chronischen Hepatitis C (HCV) -Infektion angewendet wird. Among the 87 patients who were treated with Epclusa + RBV for 12 weeks, decreases in haemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were experienced by 23% and 7% patients, respectively. No patients in the placebo group achieved SVR12. The safety and efficacy of Epclusa in the treatment of HCV infection in patients who are post-liver transplant have not been assessed. Do not store EPCLUSA or any other medicine in a bathroom or near a sink. Epclusa is contraindicated with rifabutin (see section 4.3). efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa. 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