title: Revisions in the prescribing information for Epoetin alfa: implications for nephrology nurses and patients on dialysis.
abstract: The prescribing information for Epoetin alfa administered to patients with chronic renal failure (CRF) or cancer was updated in November 2007. The revisions include revised safety information, new Epoetin alfa dosing recommendations, and revised information on health-related quality of life (HRQoL). The most significant changes included revision of the box warning, the reinstatement of a hemoglobin (Hb) range of 10 to 12 g/dL for patients with chronic renal failure, a new section on managing patients with hyporesponse to Epoetin alfa, and updated HRQoL data. These changes may necessitate revisions in anemia management protocols for patients with CRF, as well as changes in how nurses and other members of the nephrology team educate patients on the risks and benefits of Epoetin alfa therapy. Nurses will play a key role in assessing trends in laboratory values, predicting the course of Hb, and enacting appropriate physician-prescribed interventions to ensure adherence to the revised prescribing information.
authors.affiliation: Nephrology, Amgen Inc., Thousand Oaks, CA, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Hayslip
mesh_terms: D004348:Drug Labeling / Q000639:trends*; D016903:Drug Monitoring; D011307:Drug Prescriptions / Q000451:nursing; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy; D009398:Nephrology / Q000458:organization & administration; D024802:Nurse's Role; D009936:Organizational Innovation; D010353:Patient Education as Topic / Q000458:organization & administration*; D018579:Patient Selection; D011788:Quality of Life; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000451:nursing / Q000523:psychology; D017751:Safety Management / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa