Log in to search using one of your social media accounts:

 

FDA Approves Retacrit (epoetin alfa-epbx) as First Epoetin Alfa Biosimilar for the Treatment of Anemia

May 15, 2018 -- The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in...
Source: Drugs.com - New Drug Approvals - Category: Drugs & Pharmacology Source Type: news

Related Links:

CONCLUSIONS Anemia was more common in diabetic CKD patients. Diabetes mellitus was independently associated with iron deficiency. Surprisingly, diminished iron availability was not more frequent in diabetic patients. The physio-pathological mechanisms that could explain these findings remain to be elucidated.
Source: Diabetes and Metabolic Syndrome: Clinical Research and Reviews - Category: Endocrinology Source Type: research
Iron-deficiency anemia (IDA) is undertreated in patients with chronic inflammatory conditions including chronic kidney disease (CKD) and heart failure (HF). Progressive inflammation and reduced iron transport associated with CKD and HF may reduce the efficacy of oral iron therapy. Oral ferric citrate improves anemia markers in CKD, but its effects in patients with CKD and concomitant HF have not been described. Patients with CKD not on dialysis and IDA from a phase 2 and 3 trial were treated with ferric citrate (n  = 190) or placebo (n = 188); patients with HF were identified from medical histories.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
Conclusions This study demonstrated that rHuEPO is an effective neuroprotective agent in the context of CKD associated cognitive dysfunction and proved its clinical usefulness. Graphical abstract
Source: Biomedicine and Pharmacotherapy - Category: Drugs & Pharmacology Source Type: research
The Food and Drug Administration on Tuesday approved Retacrit as a biosimilar to treat anemia caused by chronic kidney disease and chemotherapy.
Source: Health News - UPI.com - Category: Consumer Health News Source Type: news
The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news
This study was a single-centered, parallel-grouped, randomized clinical trial (RCT). We randomly assigned hyperuricemia participants with eGFR 20 –60 mL/min/1.73 m2 into benzbromarone and febuxostat treatment group. Drugs were adjusted by titration from small doses.ResultsSeventy-three eligible participants enrolled, 66 subjects (33 in each group) were included finally for analysis. When compared to baseline, serum uric acid (SUA) decreased significantly after treatment in both groups, but no differences were detected among all the follow-up points. After 12-month treatment, eGFR did not have significant ch...
Source: Clinical and Experimental Nephrology - Category: Urology & Nephrology Source Type: research
ConclusionMultiple daily oral doses of 40  mg omeprazole had no significant effect on the pharmacokinetics of a single oral dose of 100 mg roxadustat. Roxadustat was considered safe and well tolerated when administered alone or in combination with multiple daily oral doses of 40 mg omeprazole in healthy subjects.
Source: European Journal of Drug Metabolism and Pharmacokinetics - Category: Drugs & Pharmacology Source Type: research
This study aimed to investigate the factors associated with resistance to recombinant human erythropoietin therapy with epoetin alfa (αEPO). We performed a prospective, longitudinal study of hemodialysis patients receiving treatment with αEPO at our reference hospital from July 2015 to June 2016. Clinical data was collected, and the response to αEPO treatment was evaluated using the erythropoietin resistance index (ERI). The ERI was defined as the weekly weight-adjusted αEPO dose (U/kg per week)/hemoglobin level (g/dL). A longitudinal linear regression model was fitted with random effects to verify ...
Source: Brazilian Journal of Medical and Biological Research - Category: Research Tags: Braz J Med Biol Res Source Type: research
Authors: Unagami K, Okumi M, Tamura T, Ishida H, Tanabe K, Nitta K Abstract Kidney transplantation represents a renal replacement therapy for end-stage renal failure, with outcomes improving from year to year. With the improved survival prognosis, treatment of complications of chronic kidney disease after transplantation is becoming increasingly important. In particular, posttransplantation anemia (PTA) is often protracted, which could be related to a variety of factors, including the renal function status, graft rejection episodes, and infectious causes. PTA occurs in about 30-40% of transplant recipients, and is ...
Source: Contributions to Nephrology - Category: Urology & Nephrology Tags: Contrib Nephrol Source Type: research
Authors: Ogawa T, Nitta K Abstract Left ventricular diastolic dysfunction (LVDD) frequently occurs in chronic kidney disease (CKD) and is associated with heart failure and higher mortality. LVDD is observed in patients with early stages of CKD and is associated with cardiovascular events, in patients undergoing incident hemodialysis in the absence of systolic function. The pathogenesis of CKD includes abnormal ventricular filling in diastole and a higher LV filling pressure (LVFP) because of LV hypertrophy (LVH), in addition to myocardial interstitial fibrosis. Therefore, LV dysfunction tends to cause pulmonary con...
Source: Contributions to Nephrology - Category: Urology & Nephrology Tags: Contrib Nephrol Source Type: research
More News: Anemia | Chemotherapy | Chronic Kidney Disease | Drugs & Pharmacology | Epogen | Food and Drug Administration (FDA) | Procrit | Urology & Nephrology