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



Drug Interaction

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


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.


EPOGEN® is contraindicated in patients with:

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


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  2. Graber SE, Krantz SB. Erythropoietin and the Control of Red Cell Production. Ann Rev Med. 1978;29:51-66.
  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.
  5. Eschbach JW, Abdulhadi MH, Browne JK, et al. Recombinant Human Erythropoietin in Anemic Patients with End-Stage Renal Disease. Ann Intern Med. 1989;111:992-1000.
  6. Eschbach JW, Egrie JC, Downing MR, et al. The Use of Recombinant Human Erythropoietin (r-HuEPO): Effect in End-Stage Renal Disease (ESRD). In: Friedman, Beyer, DeSanto, Giordano, eds. Prevention of Chronic Uremia. Philadelphia, PA: Field and Wood Inc; 1989:148-155.
  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.
  12. Stone WJ, Graber SE, Krantz SB, et al. Treatment of the Anemia of Pre-Dialysis Patients with Recombinant Human Erythropoietin: A Randomized, Placebo-Controlled Trial . Am J Med Sci. 1988;296:171-179.
  13. Braun A, Ding R, Seidel C, Fies T, Kurtz A, Scharer K . Pharmacokinetics of recombinant human erythropoietin applied subcutaneously to children with chronic renal failure. Pediatr Nephrol. 1993;7:61-64.
  14. Geva P, Sherwood JB. Pharmacokinetics of recombinant human erythropoietin (rHuEPO) in pediatric patients on chronic cycling peritoneal dialysis (CCPD). Blood. 1991;78 (Suppl 1):91a.
  15. Jabs K, Grant JR, Harmon W, et al. Pharmacokinetics of Epoetin alfa (rHuEPO) in pediatric hemodialysis (HD) patients. J Am Soc Nephrol. 1991;2:380.
  16. Kling PJ, Widness JA, Guillery EN, Veng-Pedersen P, Peters C, DeAlarcon PA. Pharmacokinetics and pharmacodynamics of erythropoietin during therapy in an infant with renal failure. J Pediatr. 1992;121:822-825.
  17. deAndrade JR and Jove M. Baseline Hemoglobin as a Predictor of Risk of Transfusion and Response to Epoetin alfa in Orthoperdic Surgery Patients. Am. J. of Orthoped. 1996;25 (8):533-542.
  18. Goldberg MA and McCutchen JW. A Safety and Efficacy Comparison Study of Two Dosing Regimens of Epoetin alfa in Patients Undergoing Major Orthopedic Surgery . Am. J. of Orthoped. 1996;25 (8):544-552.
  19. Faris PM and Ritter MA. The Effects of Recombinant Human Erythropoietin on Perioperative Transfusion Requirements in Patients Having a Major Orthopedic Operation. J. Bone and Joint surgery. 1996;78-A:62-72.
  20. Amgen Inc., data on file.
  21. Eschbach JW, Kelly MR, Haley NR, et al. Treatment of the Anemia of Progressive Renal Failure with Recombinant Human Erythropoietin. NEJM. 1989;321:158-163.
  22. The US Recombinant Human Erythropoietin Predialysis Study Group. Double-Blind, Placebo-Controlled Study of the Therapeutic Use of Recombinant Human Erythropoietin for Anemia Associated with Chronic Renal Failure in Predialysis Patients. Am J Kid Dis. 1991;18:50-59.
  23. Ortho Biologics, Inc., data on file.
  24. Danna RP, Rudnick SA, Abels RI. Erythropoietin Therapy for the Anemia Associated with AIDS and AIDS Therapy and Cancer. In: MB Garnick, ed. Erythropoietin in Clinical Applications - An International Perspective. New York, NY: Marcel Dekker; 1990:301-324.
  25. Fischl M, Galpin JE, Levine JD, et al. Recombinant Human Erythropoietin for Patients with AIDS Treated with Zidovudine. NEJM. 1990;322:1488-1493.
  26. Laupacis A. Effectiveness of Perioperative Recombinant Human Eyrthropoietin in Elective Hip Replacement. Lancet. 1993;341:1228-1232.
  27. Campos A, Garin EH. Therapy of renal anemia in children and adolescents with recombinant human erythropoietin (rHuEPO). Clin Pediatr (Phila). 1992;31:94-99.
  28. Montini G, Zacchello G, Baraldi E, et al. Benefits and risks of anemia correction with recombinant human erythropoietin in children maintained by hemodialysis. J Pediatr. 1990;117:556-560.
  29. Offner G, Hoyer PF, Latta K, Winkler L, Brodehl J, Scigalla P. One year's experience with recombinant erythropoietin in children undergoing continuous ambulatory or cycling peritoneal dialysis. Pediatr Nephrol. 1990;4:498-500.
  30. Muller-Wiefel DE, Scigalla P. Specific problems of renal anemia in childhood. Contrib Nephrol. 1988;66:71-84.
  31. Scharer K, Klare B, Dressel P, Gretz N. Treatment of renal anemia by subcutaneous erythropoietin in children with preterminal chronic renal failure. Acta Paediatr. 1993;82:953-958.
  32. Mueller BU, Jacobsen RN, Jarosinski P, et al. Erythropoietin for zidovudine-associated anemia in children with HIV infection. Pediatr AIDS and HIV Infect: Fetus to Adolesc. 1994;5:169-173.
  33. Zuccotti GV, Plebani A, Biasucci G, et al . Granulocyte-colony stimulating factor and erythropoietin therapy in children with human immunodeficiency virus infection. J Int Med Res. 1996;24:115-121.
  34. Raskin NH, Fishman RA. Neurologic Disorders in Renal Failure (First of Two Parts). NEJM. 1976;294:143-148.
  35. Raskin NH and Fishman RA. Neurologic Disorders in Renal Failure (Second of Two Parts). NEJM. 1976;294:204-210.
  36. Messing RO, Simon RP. Seizures as a Manifestation of Systemic Disease. Neurologic Clinics. 1986;4:563-584.
  37. Besarab A, Bolton WK, Browne JK, et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. NEJM. 1998;339:584-90.
  38. Henke, M, Laszig, R, Rübe, C., et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomized, double-blind, placebo-controlled trial. The Lancet. 2003; 362:1255-1260.
  39. Widness JA, Veng-Pedersen P, Peters C, Pereira LM, Schmidt RL, Lowe SL. Erythropoietin Pharmacokinetics in Premature Infants: Developmental, Nonlinearity, and Treatment Effects. J Appl Physiol. 1996;80 (1):140-148.
  40. Singh AK, Szczech L, Tang KL, et al. Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease, N Engl j Med. 2006; 355:2085-98.
  41. Bohlius J, Wilson J, Seidenfeld J, et at. Recombinant HumanErythropoietins and Cancer Patients: Updated Meta-Analysis of 57 Studies Including 9353 Patients. J Natl Cancer Inst. 2006; 98:708-14.
  42. D’Ambra MN, Gray RJ, Hillman R, et al. Effect of Recombinant Human Erythropoietin on Transfusion Risk in Coronary Bypass Patients. Ann Thorac Surg. 1997; 64: 1686-93.
  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).

Manufactured by:
Amgen Manufacturing, Limited, a subsidiary of Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799

©1989-2008 Amgen Inc. All rights reserved.

1xxxxxx – v20

Revised: 08/2008

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