Epoetin alpha

Recommendations in this section may change based on the results from the recent EPO-3 trial (epoetin alfa versus placebo). A difference in red blood cell transfusion rates was not observed between groups. Epoetin alpha therapy improved survival in trauma patients. Epoetin alfa did not have a measurable clinical benefit in medical/surgical non-trauma patients. Epoetin alpha therapy was associated with an increased thrombotic event rate, particularly in patients not receiving pharmacological deep vein thrombosis prophylaxis. 

Epoetin alpha Epogen rh Erythropoetin Growth factor 7/26/1999... 

At the start of treatment with epoetin alpha for anemia, a 60-year-old man with nephrotic syndrome developed reversible total alopecia (106). 

Podesta A, Carmagnini E, Parodi E, Dottori V, Crivellari R, Barberis L, Audo A, Lijoi A, Passerone G. Elective coronary and valve surgery without blood transfusion in patients treated with recombinant human erythropoietin (epoetin-alpha). Minerva Cardioangiol 2000 48(ll) 341-7. 

Anonymous. Epoetin alpha. Reports of pure red blood ceU aplasia. WHO Pharmaceuticals Newslett 2002 1 7. 

Veys N, Dhondt A, Lameire N. Pain at the injection site of subcutaneously administered erythropoietin phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Chn Nephrol 1998 49(1) 41. ... 

Epogen Epoetin alpha Anemia from kidney disease 3.2 6 Aranesp Darbepoetin alpha Anemia from kidney disease or chemotherapy 5 35.6... 

Epogen Epoetin alpha Renal and cancer anaemia 2,844... 

Erythropoietin is a glycoprotein (Epoetin alpha), a 165 amino acid glycoprotein with MW of 30,400 Da. 

Each 1 mL of single dose solution contains 2000, 3000, 4000 or 10,000 units of Epoetin alpha, 2.5 mg of albumin (human), 5.8 mg of sodium citrate, 5.8 mg of sodium chloride, and 0.06 mg of citric acid in water for injection, LISP (pH 6.9 0.3). This formulation contains no preservative. The 2-mL (20,000 units, 10,000 units/mL) multidose vial, each 1 mL of solution contains 10,000 units of Epoetin alpha, 2.5 mg of albumin (human), 1.3 mg of sodium citrate, 8.2 mg of sodium chloride, 0.11 mg of citric acid, and 1% benzyl alcohol as preservative in water for injection, LISP (pH 6.1 0.3). 

Roger SD, et al. Effects of early and late intervention with epoetin alpha... 

Eprex (Epoetin alpha)[CHO-expressed recombinant human protein] JANSSEN CILAG Liquid 1 mL multidose vial 0.3, 0.4, 0.5, 0.6, 0.8, and 1.0 mL single dose syringe(s)... 

Epoetin alpha (e.g., Epogen) Epoetin alpha is recombinant human erythropoietin. Erythropoetin, which is synthesized in the kidney in response to hypoxia or anemia, stimulates erythropoiesis. Epoetin alpha is indicated for anemia in patients with chronic renal failure, because these patients are unable to synthesize erythropoetin to correct the anemia. Additional uses include correcting zidovudine (AZT)-induced anemia in HIV-infected patients and chemotherapy-induced anemia in cancer patients (unlabelled use). Several weeks of therapy are required before the hematocrit levels rise, therefore, this drug cannot replace transfusions for the acute treatment of severe anemia. Epoetin alpha should not be used in patients with uncontrolled hypertension because the elevation in hematocrit may exacerbate hypertension. 

Table 12.4-1 shows the expiration dates of the patents of several recombinant DNA-derived therapeutic proteins. The patents of products as interferon alpha and epoetin alpha have already expired, and others will follow shortly. Table 12.4-1 also shows the patent and data protection to last longer in the United States than in Europe. This partly explains why the regulations regarding the conditions for marketing authorization in the EU are more developed than in the United States. 

Figure 12.4-1. An example of biosimilar epoetins. This figure shows epoetin alpha s marketed in Asia and South America analyzed by iso-electrical focusing. The different products show large differences in isotype content. Difference can also be seen between different batches of the same manufacturer (lA and IB IIA and IIB IIIA and IIIB). E is the epoetin alpha marketed in Europe.

The marketed products are formulated as a sterile, colorless, preservative-free liquid for intravenous or subcutaneous administration. The vial should not be shaken, or the glycoprotein may become denatured, rendering it inactive. Epoetin alpha is indicated for the treatment of various anemias. Several of the conditions are listed in Table 6.4. Epoetin alpha represents a major scientific advance in the treatment of patients with chronic renal failure, serving as a replacement therapy for inadequate production of endogenous EPO by failing kidneys. Epoetin alpha may decrease the need for infusions in dialysis patients. By several mechanisms related to elevating the erythroid progenitor cell pool, epoetin alpha increases the production of red blood cells. 

Glaspy JA, Charu V, Luo D, Moyo V, Kamin M, Wilhelm FE. Initiation of epoetin-alpha therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy an open-label, multicenter study with randomized and nonrandomized treatment arms. Cancer 2009 115(5) 1121-31. 

Caldini, A., Moneti, G., Fanelli, A., et al. (2003) Epoetin alpha, epoetin beta and darbepoetin alfa Two-dimensional gel electrophoresis isoforms characterization and mass spectrometry analysis. Proteomics, 3,937-941. 

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