"The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfiel"...
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
This monograph has been modified to include the generic and brand name in many instances.
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