FDA approves first epoetin alfa biosimilar for the treatment of anemia

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

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Anemia is a condition characterized by a deficiency of red blood cells (RBCs) or hemoglobin (Hb), resulting in a diminished capacity of the blood to carry and deliver oxygen to tissues and organs (Abbasi et al., 2014). Anemia is often multifactorial in etiology and may be patient- (e.g., iron-deficiencies, vitamin deficiencies), disease- (e.g., bone marrow diseases, chronic diseases, hemorrhage), or anticancer treatment- (e.g., chemotherapy, radiotherapy, precision therapies) related (Crathorne et al., 2016).
Source: Critical Reviews in Oncology Hematology - Category: Cancer & Oncology Authors: Source Type: research
The first biosimilar to epoetin alfa for patients with anemia from chronic kidney disease, chemotherapy, or zidovudine treatment for HIV infection has receivedFDA approval.
Source: JAMA - Category: General Medicine 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
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
​BY NOURA MAHDI; DARRON LEWIS; JEREMY OSBORNE; &AHMED RAZIUDDIN, MDA 73-year-old man was brought to the emergency department from his nursing home for rectal bleeding and anemia. The patient mentioned he had had episodes of bright red rectal bleeding and constipation for a few months. A colonoscopy had been done prior to the visit, which revealed a large intestine tumor and biopsy confirming adenocarcinoma. He was awaiting an appointment with his surgeon.The patient reported bloody rectal leakage, and a CBC done at the nursing home showed a hemoglobin level of 7.2. He also complained of dyspnea but denied any other s...
Source: The Case Files - Category: Emergency Medicine Tags: Blog Posts Source Type: research
Authors: Yoo SH, Lim J, Byun JM, Park JH, Kim KH, Choi IS Abstract Chronic myelomonocytic leukemia (cmml) is an indolent disease in the category of myelodysplastic and myeloproliferative neoplasms, which can often evolve into acute leukemic neoplasms. Although cytogenetic abnormalities such as trisomy 8 or absence of chromosome Y are well known, few reports about cmml with trisomy 11 have been published. Here, we report a case of cmml with trisomy 11 as the sole chromosomal abnormality, resulting in a very poor outcome. Based on a bone marrow specimen, cmml-1 with trisomy 11 was diagnosed in a 79-year-old man prese...
Source: Current Oncology - Category: Cancer & Oncology Tags: Curr Oncol Source Type: research
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Source: International Journal of Cancer - Category: Cancer & Oncology Authors: Tags: Mini Review Source Type: research
Abstract Multiple myeloma is one of the most common malignancies encountered in clinical practice. Renal involvement in myeloma is a well-recognized entity. Although rare, another special situation that a nephrologist can encounter is myeloma occurring in a patient with preexisting chronic kidney disease (CKD) due to other etiologies. Anemia, bone pains and hypercalcemia, which commonly indicate the diagnosis of myeloma in the general population, are not useful in the presence of CKD. The sensitivity and specificity of serum free light chain assay is decreased in the presence of renal failure. Chemotherapy-related...
Source: Saudi Journal of Kidney Diseases and Transplantation - Category: Urology & Nephrology Authors: Tags: Saudi J Kidney Dis Transpl Source Type: research
Conclusions: It appears that for the diagnosis of ID, a cutoff of 100 μg/L for serum ferritin concentration should be considered in most conditions and 20% for TSAT, except in particular situations, including young healthy women with heavy menstrual flow. New indications of intravenous iron supplementation are emerging.
Source: American Journal of Clinical Nutrition - Category: Nutrition Authors: Tags: International nutrition Source Type: research
CONCLUSIONS: It appears that for the diagnosis of ID, a cutoff of 100 μg/L for serum ferritin concentration should be considered in most conditions and 20% for TSAT, except in particular situations, including young healthy women with heavy menstrual flow. New indications of intravenous iron supplementation are emerging. PMID: 26561626 [PubMed - as supplied by publisher]
Source: The American Journal of Clinical Nutrition - Category: Nutrition Authors: Tags: Am J Clin Nutr Source Type: research
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