The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes

Kidney International

Volumn 67, Issue 6, 2005, Pages 2346-2353

  Boven, Katia ^b   Stryker, Scott ^b   Knight, John ^b   Thomas, Adrian ^b   Van Regenmortel, Marc ^b   Kemeny, David M ^b   Power, David ^b   Rossert, Jerome ^b   Casadevall, Nicole ^a  

^a HÔTEL DIEU   (France)

^b NONE

Author keywords

Antibodies; Epoetin alfa; Erythropoietin; Pure red cell aplasia

Indexed keywords

POLYSORBATE 80; RECOMBINANT ERYTHROPOIETIN; RUBBER; POLYSORBATE;

ARTICLE; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; EQUIPMENT DESIGN; HUMAN; IMMUNOGENICITY; INCIDENCE; LEACHING; PRIORITY JOURNAL; PURE RED CELL ANEMIA; RETROSPECTIVE STUDY; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SYRINGE; CHEMICALLY INDUCED DISORDER; CHEMISTRY;

CHEMISTRY, PHARMACEUTICAL; ERYTHROPOIETIN, RECOMBINANT; HUMANS; INCIDENCE; POLYSORBATES; RED-CELL APLASIA, PURE; SYRINGES;

EID: 19044392727     PISSN: 00852538     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1523-1755.2005.00340.x     Document Type: Article

References (15)

1. DESSYPRIS EN: Pure red cell aplasia, in Hematology: Basic Principles and Practice, edited by Hoffman R, Benz, EJ, Shattil SF et al., 3rd ed., New York, Churchill Livingstone, 1999, pp 342-354
2. ECKARDT KU, CASADEVALL N: Pure red-cell aplasia due to antierythropoietin antibodies. Nephrol Dial Transplant 18:865-869, 2003
3. BERGREM H, DANIELSON BG, ECKARDT KU, et al: A case of antierythropoietin antibodies following recombinant human erythropoietin treatment, in Erythropoietin: Molecular Physiology and Clinical Applications, edited by Bauer C, Koch KM, Scigalla P, Wieczorek L, New York, Marcel Dekker, 1993, pp 265-273
4. PECES R, DE LA TORRE M, ALCÁZAR R, URRA JM: Antibodies against recombinant human erythropoietin in a patient with erythropoietin-resistant anemia. N Engl J Med 335:523-524, 1996
5. PRABHAKAR SS, MUHLFELDER T: Antibodies to recombinant human erythropoietin causing pure red cell aplasia. Clin Nephrol 47:331-335, 1997
6. CASADEVALL N, NATAF J, VIRON B, et al: Pure red-cell aplasia and anti-erythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 346:469-475, 2002
7. CASADEVALL N: Antibodies against rHuEPO: Native and recombinant. Nephrol Dial Transplant 17(Suppl 5):42-47, 2002
8. KRUGER A, SCHROER W, ROHRS F, VESCIO G: PRCA in a patient treated with epoetin beta. Nephrol Dial Transplant 18:1033-1034, 2003
9. LOCATELLI F, ALJAMA P, BARAMY P, et al: Erythropoiesis-stimulating agents and antibody-mediated pure red-cell aplasia: Where are we now and where do we go from here? Nephrol Dial Transplant 19:288-293, 2004
10. ROSSERT J, CASADEVALL N, ECKARDT KU: Anti-erythropoietin antibodies and pure red cell aplasia. J Am Soc Nephrol 15:398-406, 2004
11. WEGEWIJS HW: The supply chain for biopharmaceuticals: A manufacturer's view. Eur J Hosp Pharm 1:86-88, 2003
12. SHARMA B, BADER F, TEMPLEMAN T, et al: Technical investigations into the cause of the increased incidence of antibody-mediated pure red cell aplasia associated with EPREX. Eur J Hosp Pharm 5:86-91, 2004
13. JENKE D: Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. PDA J Pharm Sci Technol 56:332-371, 2002
14. Ross C, CLEMMESEN KM, SVENSON M, et al: Immunogenicity of interferon-beta in multiple sclerosis patients: Influence of preparation, dosage, dose frequency, and route of administration. Ann Neurol 48:706-712, 2000
15. BENNETT C, LUMINARI S, NISSENSON A, et al: Pure red-cell aplasia and recombinant epoetin therapy - A follow-up report from the research on adverse drug events and reports project. N Engl J Med 351:1403-1408, 2004