Adverse Events of Subcutaneous Recombinant Human Erythropoietin Therapy

2015 ◽  
pp. 127-138 ◽  
Author(s):  
Horst Klinkmann ◽  
Reinhard Schmidt ◽  
Lothar Wieczorek ◽  
Paul Scigalla
Keyword(s):  
Adverse Events ◽  
Recombinant Human Erythropoietin ◽  
Human Erythropoietin

scholarly journals Safety and efficacy of recombinant human erythropoietin in correcting the anemia of patients with chronic renal allograft dysfunction.

1994 ◽  
Vol 5 (5) ◽  
pp. 1216-1222
Author(s):  
N Muirhead ◽  
D C Cattran ◽  
J Zaltzman ◽  
K Jindal ◽  
M R First ◽  
...  
Keyword(s):  
Adverse Events ◽  
Serum Ferritin ◽  
Recombinant Human Erythropoietin ◽  
Renal Allograft ◽  
Sickness Impact Profile ◽  
Binding Capacity ◽  
Transferrin Saturation ◽  
Human Erythropoietin ◽  
Change In Mean ◽  
Disease Questionnaire

Recombinant human erythropoietin (rHuEPO) is effective in correcting anemia in hemodialysis, peritoneal dialysis, and predialysis patients. Limited studies in patients with failing renal allografts suggest a similar efficacy but provide little information concerning benefits, dose requirements, or adverse events. This study examined these considerations in a group of 40 patients (18 men; 22 women) aged 40.3 +/- 13.8 yr with stable, chronic renal allograft failure. All patients had a hemoglobin < 95 g/L and a serum creatinine > 250 mumol/L at baseline. Patients received rHuEPO (50 U/kg sc) three times weekly for 24 wk along with iron po if serum ferritin was < 100 micrograms/L. Mean hemoglobin rose from 78.9 +/- 10.4 to 102.6 +/- 18.4 g/L after 24 wk. Mean rHuEPO dose at 24 wk was 129.8 +/- 81.9 U/kg per week. With oral iron supplementation only, serum ferritin fell throughout the 24 wk, whereas serum iron, transferrin saturation, and total iron-binding capacity remained stable. Quality of life was assessed by use of the general Sickness Impact Profile and the disease-specific Transplant Disease Questionnaire measures at baseline and every 8 wk during rHuEPO therapy. Significant improvement was noted in global Sickness Impact Profile scores and in four of five dimensions of the Transplant Disease Questionnaire. Serious adverse events were infrequent. No change in mean systolic or diastolic blood pressure was noted, although there was a significantly increased need for antihypertensive drugs in 18 patients (P = 0.0002). A significant inverse correlation was noted between baseline renal function and maintenance rHuEPO dose (r = -0.45; P < 0.05). Twelve patients returned to dialysis during the study.(ABSTRACT TRUNCATED AT 250 WORDS)

scholarly journals Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease

2018 ◽  
Vol 13 (8) ◽  
pp. 1204-1214 ◽  
Author(s):  
Steven Fishbane ◽  
Bhupinder Singh ◽  
Seema Kumbhat ◽  
Wayne A. Wisemandle ◽  
Nancy E. Martin
Keyword(s):  
Body Weight ◽  
Adverse Events ◽  
Confidence Interval ◽  
Least Squares ◽  
Recombinant Human Erythropoietin ◽  
Neutralizing Antibodies ◽  
Mean Difference ◽  
Epoetin Alfa ◽  
Human Erythropoietin ◽  
Equivalence Margin

Background and objectivesThis study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia.Design, setting, participants, & measurementsIn this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx. Dosing was adjusted according to the epoetin alfa prescribing information. The coprimary efficacy end points were the least squares mean difference between the two treatments in mean weekly hemoglobin level and mean weekly epoetin dose per kilogram of body weight during the last 4 weeks of treatment.ResultsThe least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly hemoglobin was −0.12 g/dl and the 95% confidence interval (−0.25 to 0.01) was contained within the prespecified equivalence margin (−0.5 to 0.5 g/dl). The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of body weight was 0.37 U/kg per week, and the 95% confidence interval (−10.40 to 11.13) was contained within the prespecified equivalence margin (−45 to 45 U/kg per week). Incidences of adverse events (77.1% versus 75.3%), serious adverse events (24.9% versus 27.0%), and deaths (n=5 versus 6) were similar between the epoetin alfa-epbx and epoetin alfa groups, respectively. Five patients tested positive for anti-recombinant human erythropoietin antibodies at baseline, and two additional patients (n=1 per group) developed anti-recombinant human erythropoietin antibodies while on study treatment. All patients tested negative for neutralizing antibodies, and no patient in either group experienced an event of pure red cell aplasia.ConclusionsThis 24-week, comparative, clinical trial in patients on hemodialysis with ESKD and anemia demonstrated there is no clinically meaningful difference in efficacy or safety between epoetin alfa-epbx and epoetin alfa.

Correlation Between Recombinant Human Erythropoietin Dose and Inflammatory Status in Dialysed Patients

2017 ◽  
Vol 68 (2) ◽  
pp. 354-357 ◽  
Author(s):  
Andrei Niculae ◽  
Cristiana David ◽  
Razvan Florin Ion Dragomirescu ◽  
Ileana Peride ◽  
Flavia Liliana Turcu ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Recombinant Human Erythropoietin ◽  
Best Practice ◽  
Daily Practice ◽  
Therapeutic Benefit ◽  
Chronic Dialysis ◽  
Dialysis Patients ◽  
Protein Levels ◽  
Human Erythropoietin ◽  
Inflammatory Status

Once recombinant human erythropoietin (r-HuEPO) was introduced in daily practice, huge steps were made in combating the adverse effects induced by anemia in chronic kidney disease population. Still, r-HuEPO resistance and the doses ensuring the maximum therapeutic benefit remain matters of debate. The aim of our study was to assess the correlation between the presence and the degree of inflammation and the r-HuEPO requirements in chronic dialysis patients. We conducted a 2 years prospective study on 146 patients undergoing chronic dialysis treated with r-HuEPO. Based on their average CRP (C-reactive protein) levels, obtained from repeated samplings at 3 months interval, 3 groups were formed; we noted in each group the average values of r-HuEPO prescribed to achieve the optimum hemoglobin levels according to the dialysis best practice guidelines and all the adverse effects of the therapy. A direct correlation was observed between CRP levels and r-HuEPO requirements in the first 2 groups of patients (CRP under 6 mg/L and CRP values 6-20 mg/L), with significant increase in r-HuEPO doses between groups (p [ 0.001); the third group, CRP values over 20 mg/dL, showed a minor, insignificant increase in average r-HuEPO doses compared to mild inflammation group (p = 0.199) and more adverse effects of the therapy (p [ 0.05). Inflammation is an important determinant of anemia in chronic dialysis patients and can induce an increase in the doses of r-HuEPO. However, prescribing excessive r-HuEPO doses is not the answer in severe inflammatory status, due to lack of response and possible adverse effects.

Biochemical and Biological Quality Control of Two Recombinant Human Erythropoietin Biosimilar Products

2017 ◽  
Vol 13 (6) ◽  
Author(s):  
Rym Hassiki ◽  
Jamila Behi ◽  
Nadia Ben Said ◽  
Lassaad Boujbel ◽  
Balkiss Bouhaouala-Zahar
Keyword(s):  
Quality Control ◽  
Recombinant Human Erythropoietin ◽  
Biological Quality ◽  
Human Erythropoietin

scholarly journals Effect of Recombinant Human Erythropoietin on Nutritional Status and Plasma Lipids in Uremic Patients

Nephron ◽  
1992 ◽  
Vol 60 (2) ◽  
pp. 249-249 ◽  
Author(s):  
B. Viron ◽  
R. Donsimoni ◽  
C. Michel ◽  
R. Al Khayat ◽  
F. Mignon
Keyword(s):  
Nutritional Status ◽  
Recombinant Human Erythropoietin ◽  
Plasma Lipids ◽  
Human Erythropoietin ◽  
Uremic Patients
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