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BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that over 60 percent of surveyed nephrologists in the United States expect to begin prescribing biosimilar epoetin alfa within the first 12 months of launch.

The FDA is using the term “follow-on biologics” ().

This is not surprising as the monoclonal antibody products on the market are very profitable and can generate huge revenues.

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You may receive epoetin alfa at your treatment site or self-administer at home.

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In addition to epoetin, your body needs iron to make red blood cells.

Note: Evaluate iron status in all patients before and during treatment and maintain iron repletion.

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The black-box warning added to the prescribing information for epoetin alfa and darbepoetin in March 2007 references this trial and specifies that “ESAs are not indicated for this population” of patients with active malignant disease receiving neither chemotherapy nor radiation therapy.

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Current medical practice involving RBC transfusion or administration of ESAs as anaemia therapy is typically limited to certain patient populations.

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Up to 60 patients will take part in this study.

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Pure red cell aplasia and anti-erythropoietin antibodies in patients treated with epoetin.

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The hemoglobin should be determined twice a week until it has stabilized in the suggested hemoglobin range and the maintenance dose has been established.

Single-use vials are frequently preservative-free and might pose a risk for contamination if they are punctured several times.

The BEST study randomized 939 women with metastatic breast cancer receiving first-line chemotherapy to epoetin alfa versus placebo in a double-blind fashion.

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No differences in the safety profile and anti-epoetin antibody response were detected between the biosimilars and their reference products.

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Several reviews and National Comprehensive Cancer Network guidelines outline numerous studies that support the beneficial effects of exercise on fatigue.

Study 6 was a randomized, open-label, controlled study conducted in 522 patients with primary squamous cell carcinoma of the head and neck receiving radiation therapy alone (no chemotherapy) who were randomized to receive darbepoetin alfa to maintain hemoglobin levels of 14 to15.

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Rate of hemoglobin decline indicates the likelihood of requiring an RBC transfusion and reducing the risk of alloimmunization or other RBC transfusion-related risks is a goal.

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Inflammatory cytokines have also been found to induce the production of hepcidin, a recently discovered peptide generated in the liver, which interferes with RBC production by decreasing iron availability for incorporation into erythroblasts.

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Although some samples had low levels of eEpo because of the high haematocrits, and therefore relatively high oxygen levels in blood resulting in an inhibition of eEpo synthesis, other samples may have been manipulated.

Anaemia: Does the KDIGO guideline move the needle in CKD anaemia?

They are Pregnancy Category X drugs, and therefore deferral is recommended for blood donors on either of these medications.

The contents of the pills are absolutely the same in our generic version as in the branded analogue.

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The finding of a cost difference favouring epoetin alpha over darbepoetin alpha suggests the need for prospective randomized studies comparing efficacy and cost effectiveness of all three agents to obtain more definitive data.

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The second issue is of major importance to the use of recombinant erythropoietin to treat any hematologic neoplastic disease.

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ESRD, end-stage renal disease; GFR, glomerular filtration rate.

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Educate patients and their families about dialysis to avoid the shock of emergent dialysis and the decreased quality of life that can occur with uremia.

Effect of Hemoglobin Target on Progression of Kidney Disease: A Secondary Analysis of the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) Trial.

As suggested above, some of what Gonzalez has written, if true, is pertinent to the proper reporting of the trial and to its ethics, even if it does not negate the overwhelming conclusion.

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We cannot determine whether a poor initial response to an ESA places patients at increased risk for these adverse outcomes or whether the risk was augmented by the higher doses of darbepoetin alfa they received.

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Where side effects have been reported, they have been among patients taking many times more than the normal therapeutic dose of the drug.

Epoetin alfa is a medicine used to treat anemia due to chemotherapy, renal failure, or zidovudine.

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FDA briefing information for the joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee.

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You may need to stop epoetin alfa if this occurs.

Epoetin alfa injection is also used to treat anemia caused by chemotherapy in people with certain types of cancer or caused by zidovudine (AZT, Retrovir, in Trizivir, in Combivir), a medication used to treat human immunodeficiency virus (HIV).

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Unfortunately, there is very limited clinical data on the immunogenicity of mAb biosimilars, since they have not yet entered the EU or US drug market.

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Darbepoetin for the anaemia of chronic kidney disease.

Using the phrase chronic fatigue can be confusing to both patients and health professionals.

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There was no significant between-group difference in the use of intravenous iron at baseline, the percent of patients receiving intravenous iron during the first 12 weeks of therapy or over the course of the trial, the time to the use of intravenous iron, or the amount of intravenous iron received.

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These include the disease state of the patients, genetic factors, age, concomitant medication, duration and route of administration, and previous exposure to similar proteins.

Collaborators are asked to agree to a simple user agreement and to register their use of a FACIT questionnaire by completing a Collaborators' Project Information Form.

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Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: A survival study.

The TOI can be computed for any FACIT disease-, treatment-, or condition-specific scale.

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The search for other agents and methods that could provide ergogenic benefit in athletes continued.

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Drug-related adverse events led to study discontinuation in six patients (two in the FG group, four in the oral iron group).

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Select patients with clinically decompensated disease may be candidates for treatment in research protocols.

In September 2014, Colombia released new regulations for the approval of biosimilars in the country.

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