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The FDA might consider undertaking a range of new activities in regulating off-label use, including systematically collecting postmarketing data to quantify the harms and benefits of common off-label uses; synthesizing evidence regarding off-label uses and disseminating its reports; scrutinizing marketing efforts to restrict materials on off-label uses that don't have strong support; increasing the use of active drugs as comparators in postmarketing clinical trials; and requiring information about anticipated off-label uses to be presented at the time of a drug's review for initial approval.

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Corrects erythropoietic abnormalities caused by a deficiency of iron.

Use the lowest dose of epoetin alfa necessary to avoid RBC transfusions.

Chemotherapy is rarely used early in the term, because it poses a risk for birth defects.

In the absence of such data, 48 wk of therapy should be offered, as this was the treatment duration studied in clinical trials of HIV-infected patients with concurrent HCV genotype 2 or 3 infection.

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Mexico's health authority COFEPRIS published official guidelines for biosimilar evaluation in 2011.

No large clinical trials of erythropoietin treatment have been done in anemic kidney transplant recipients, however.

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An overview on safety issues related to erythropoiesis-stimulating agents for the treatment of anaemia in patients with chronic kidney disease.

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Off-Label Prescribing of Drugs in Child and Adolescent Psychiatry.

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Structure-based drug design for hypoxia-inducible factor prolyl-hydroxylase inhibitors and its therapeutic potential for the treatment of erythropoiesis-stimulating agent-resistant anemia: raising expectations for exploratory clinical trials.

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Newly constructed FACIT subscales then undergo an initial assessment of reliability and validity using a sample of at least 50 patients.

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The dose should be reduced if the hemoglobin level reaches 12 grams per decaliter or if the hemoglobin level increases by more than 1 gram per decaliter in any two-week period.

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Baseline and periodic monitoring of iron, total iron-binding capacity, transferrin saturation, or ferritin levels and instituting iron repletion when indicated, may be valuable in limiting the need for epoetin or darbepoetin, maximizing symptomatic improvement for patients, and determining the reason for failure to respond adequately to ESA therapy.

Early detection of CKD: the benefits, limitations and effects on prognosis.

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Benefits of Epoetin Alfa in Anemic Breast Cancer Patients Receiving Chemotherapy.

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The target-based approach of our study mimics the target-based strategies that have been clinically used to treat anemia in patients with chronic kidney disease who have a reduced initial response, with higher doses of darbepoetin alfa used to attain the target hemoglobin level.

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If no alternative cause for the anemia is found, therapy with erythropoietin-stimulating agents (ESAs) is initiated usually at a nephrologist's office.

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First biosimilars introduced in 2008.

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The estimation is that at least 19% of these patients had cognitive dysfunction or impairment in memory and concentration, which was also correlated with a decrease in hemoglobin.

Yogo K, Ishida-Kitagawa N, Takeya T (2007).

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