Epogen (Epoetin Alfa) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Drug Interaction

No evidence of interaction of EPOGEN^® with other drugs was observed in the course of clinical trials.

OVERDOSAGE

The expected manifestations of EPOGEN^® overdosage include signs and symptoms associated with an excessive and/or rapid increase in hemoglobin concentration, including any of the cardiovascular events described in WARNINGS and listed in ADVERSE REACTIONS. Patients receiving an overdosage of EPOGEN^® should be monitored closely for cardiovascular events and hematologic abnormalities. Polycythemia should be managed acutely with phlebotomy as clinically indicated. Following resolution of the effects due to EPOGEN^® overdosage, reintroduction of EPOGEN^® therapy should be accompanied by close monitoring for evidence of rapid increases in hemoglobin concentration (>1 gm/dL per 14 days). In patients with an excessive hematopoietic response, reduce the EPOGEN^® dose in accordance with the recommendations described in DOSAGE AND ADMINISTRATION.

CONTRAINDICATIONS

EPOGEN^® is contraindicated in patients with:

1. Uncontrolled hypertension.
2. Known hypersensitivity to mammalian cell-derived products.
3. Known hypersensitivity to Albumin (Human).

REFERENCES

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3. Eschbach JW, Adamson JW. Anemia of End-Stage Renal Disease (ESRD). Kidney Intl. 1985;28:1-5.
4. Eschbach JW, Egrie JC, Downing MR, et al. Correction of the Anemia of End-Stage Renal Disease with Recombinant Human Erythropoietin. NEJM. 1987;316:73-78.
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7. Egrie JC, Eschbach JW, McGuire T, Adamson JW. Pharmacokinetics of Recombinant Human Erythropoietin (r­HuEPO) Administered to Hemodialysis (HD) Patients. Kidney Intl. 1988;33:262.
8. Paganini E, Garcia J, Ellis P, et al. Clinical Sequelae of Correction of Anemia with Recombinant Human Erythropoietin (r-HuEPO); Urea Kinetics, Dialyzer Function and Reuse. Am J Kid Dis. 1988;11:16.
9. Delano BG, Lundin AP, Golansky R, et al. Dialyzer Urea and Creatinine Clearances Not Significantly Changed in r­HuEPO Treated Maintenance Hemodialysis (MD) Patients. Kidney Intl. 1988;33:219.
10. Stivelman J, Van Wyck D, Ogden D. Use of Recombinant Erythropoietin (r-HuEPO) with High Flux Dialysis (HFD) Does Not Worsen Azotemia or Shorten Access Survival. Kidney Intl. 1988;33:239.
11. Lim VS, DeGowin RL, Zavala D, et al. Recombinant Human Erythropoietin Treatment in Pre-Dialysis Patients: A Double-Blind Placebo Controlled Trial. Ann Int Med.
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43. Leyland-Jones B, Semiglazov V, Pawlicki M, et al. Maintaining Normal Hemoglobin Levels With Epoetin Alfa in Mainly Nonanemic Patients With Metastatic Breast Cancer Receiving First-Line Chemotherapy: A Survival Study. JCO. 2005; 23(25): 1-13.

This product’s label may have been revised after this insert was used in production. For further product information and the current package insert, please visit www.amgen.com or call our medical information department toll-free at 1-800-77AMGEN (1-800-772-6436).

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©1989-2008 Amgen Inc. All rights reserved.

1xxxxxx – v20

Revised: 08/2008