"The U.S. Food and Drug Administration approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs). For patients with cancer, the program "...
Epogen overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Epogen dosage and/or with phlebotomy, as clinically indicated [see Pharmacodynamics]. Cases of severe hypertension have been observed following overdose with ESAs [see WARNINGS AND PRECAUTIONS].
Epogen is contraindicated in patients with:
- Uncontrolled hypertension [see WARNINGS AND PRECAUTIONS]
- Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs [see WARNINGS AND PRECAUTIONS]
- Serious allergic reactions to Epogen [see WARNINGS AND PRECAUTIONS]
Epogen from multidose vials contains benzyl alcohol and is contraindicated in:
- Neonates, infants, pregnant women, and nursing mothers. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. When therapy with Epogen is needed in neonates and infants, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol [see Use In Specific Populations].
Last reviewed on RxList: 6/20/2012
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