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Index of reports
> Cases with Anti-Erythropoietin Antibody Positive (15)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Epogen (Epoetin Alfa) where reactions include anti-erythropoietin antibody positive. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Epogen side effects in 3 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26
Patient: 3 year old male
Reactions: Haemoglobin Decreased, Haematocrit Decreased, Anti-Erythropoietin Antibody Positive, Blood Erythropoietin Decreased, Neutralising Antibodies Positive, Aplasia Pure RED Cell, Reticulocyte Count Abnormal
Drug(s) suspected as cause:
Epogen
Dosage: 10000 iu, 5 times/wk
Indication: Dialysis
Start date: 2011-10-18
Epogen
Start date: 2011-10-01
Epogen
Dosage: 3000 iu, 3 times/wk
Start date: 2011-08-12
Epogen
Dosage: 2400 iu, 2 times/wk
Start date: 2010-10-01
Other drugs received by patient: Calcitriol; Nephrovite; Clonidine; Norvasc; Calcium Carbonate; Ferrous Sulfate TAB; Ergocalciferol; Prilosec; Enalapril Maleate; Prilosec
Possible Epogen side effects in 34 year old male
Reported by a physician from United States on 2012-07-06
Patient: 34 year old male
Reactions: Anti-Erythropoietin Antibody Positive, Anaemia, Aplasia Pure RED Cell, Iron Overload
Drug(s) suspected as cause:
Epogen
Epogen
Dosage: unk
Indication: Renal Transplant
Aranesp
Dosage: unk
Indication: Renal Transplant
Other drugs received by patient: Prograf; Prednisolone; Azathioprine; Fludrocortisone Acetate
Possible Epogen side effects in 3 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: 3 year old male
Reactions: Haemoglobin Decreased, Haematocrit Decreased, Anti-Erythropoietin Antibody Positive, Blood Erythropoietin Decreased, Neutralising Antibodies Positive, Aplasia Pure RED Cell, Reticulocyte Count Abnormal
Drug(s) suspected as cause:
Epogen
Dosage: 3000 iu, 3 times/wk
Start date: 2011-08-12
Epogen
Start date: 2011-10-01
Epogen
Dosage: 10000 iu, 5 times/wk
Indication: Dialysis
Start date: 2011-10-18
Epogen
Dosage: 2400 iu, 2 times/wk
Start date: 2010-10-01
Other drugs received by patient: Calcium Carbonate; Calcitriol; Nephrovite; Prilosec; Clonidine; Ferrous Sulfate TAB; Ergocalciferol; Enalapril Maleate; Norvasc; Prilosec
Possible Epogen side effects in 53 year old male
Reported by a physician from United States on 2012-06-06
Patient: 53 year old male, weighing 81.2 kg (178.6 pounds)
Reactions: Therapeutic Response Decreased, Myelofibrosis, Haemoglobin Decreased, Anti-Erythropoietin Antibody Positive
Drug(s) suspected as cause:
Epogen
Dosage: 20000 unit, qwk
Indication: Renal Failure Chronic
Start date: 2009-12-09
Epogen
Dosage: 20000 unit, 3 times/wk
Start date: 2012-01-16
Other drugs received by patient: Prednisone TAB; Renvela; Folic Acid; Danazol
Possible Epogen side effects in 53 year old male
Reported by a physician from United States on 2012-05-28
Patient: 53 year old male
Reactions: Haemoglobin Decreased, Therapeutic Response Decreased, Anti-Erythropoietin Antibody Positive
Drug(s) suspected as cause:
Epogen
Possible Epogen side effects in 3 year old male
Reported by a physician from United States on 2012-05-09
Patient: 3 year old male
Reactions: Haemoglobin Decreased, Haematocrit Decreased, Anti-Erythropoietin Antibody Positive, Blood Erythropoietin Decreased, Neutralising Antibodies Positive, Aplasia Pure RED Cell, Reticulocyte Count Abnormal
Drug(s) suspected as cause:
Epogen
Start date: 2011-10-01
Epogen
Dosage: 2400 iu, 2 times/wk
Start date: 2010-10-01
Epogen
Dosage: 10000 iu, 5 times/wk
Indication: Dialysis
Start date: 2011-10-18
Epogen
Dosage: 3000 iu, 3 times/wk
Start date: 2011-08-12
Other drugs received by patient: Nephrovite; Calcitriol; Prilosec; Calcium Carbonate; Enalapril Maleate; Norvasc; Prilosec; Clonidine; Ergocalciferol; Ferrous Sulfate TAB
Possible Epogen side effects in 33 year old male
Reported by a pharmacist from United States on 2012-04-26
Patient: 33 year old male, weighing 140.0 kg (308.0 pounds)
Reactions: Pseudomonas Infection, Anaemia, Haemoglobin Decreased, Therapeutic Response Decreased, Anti-Erythropoietin Antibody Positive, Staphylococcal Infection, Oedema Peripheral, Neutralising Antibodies Positive, Aplasia Pure RED Cell, Vascular Access Complication, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epogen
Dosage: unk
Start date: 2010-01-01
End date: 2011-09-26
Epogen
Dosage: 5000 iu, qwk
Start date: 2009-06-30
End date: 2009-07-02
Epogen
Dosage: unk
Start date: 2012-02-01
Epogen
Dosage: 20000 iu, 2 times/wk
Indication: Nephrogenic Anaemia
Start date: 2012-02-23
Epogen
Dosage: 15000 iu, 3 times/wk
Start date: 2012-01-21
End date: 2012-01-25
Epogen
Dosage: 10000 iu, 3 times/wk
Start date: 2012-01-04
End date: 2012-01-20
Epogen
Dosage: 12000 iu, qwk
Start date: 2011-12-12
Epogen
Dosage: 8000 iu, 3 times/wk
Start date: 2009-08-10
End date: 2009-09-09
Epogen
Dosage: 20000 iu, 3 times/wk
Start date: 2012-01-26
End date: 2012-02-22
Epogen
Dosage: 10000 iu, qwk
Start date: 2011-12-03
End date: 2011-12-11
Epogen
Dosage: 10000 iu, 3 times/wk
Start date: 2009-07-08
End date: 2009-08-10
Epogen
Dosage: 6000 iu, qwk
Start date: 2011-09-27
End date: 2011-12-02
Epogen
Dosage: 10000 iu, 2 times/wk
Start date: 2009-07-02
End date: 2009-07-08
Other drugs received by patient: Ceftazidime; Ceftazidime; Venofer; Heparin; Ceftriaxone; Vancomycin; Metoprolol Tartrate; Heparin; Renvela; Vancomycin; Lisinopril; Proair HFA; Vancomycin; Qvar 40
Possible Epogen side effects in 33 year old male
Reported by a physician from United States on 2012-04-13
Patient: 33 year old male, weighing 140.0 kg (308.0 pounds)
Reactions: Therapeutic Response Decreased, Haemoglobin Decreased, Staphylococcal Infection, Anti-Erythropoietin Antibody Positive, Anaemia, Pseudomonas Infection, Neutralising Antibodies Positive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epogen
Dosage: 20000 iu, 2 times/wk
Indication: Nephrogenic Anaemia
Start date: 2012-02-23
Epogen
Dosage: 10000 iu, 3 times/wk
Start date: 2012-01-04
End date: 2012-01-20
Epogen
Dosage: 6000 iu, qwk
Start date: 2011-09-27
End date: 2011-12-02
Epogen
Dosage: 10000 iu, qwk
Start date: 2011-12-03
End date: 2011-12-11
Epogen
Dosage: 10000 iu, 2 times/wk
Start date: 2009-07-02
End date: 2009-07-08
Epogen
Dosage: 8000 iu, 3 times/wk
Start date: 2009-08-10
End date: 2009-09-09
Epogen
Dosage: 5000 iu, qwk
Start date: 2009-06-30
End date: 2009-07-02
Epogen
Dosage: unk
Start date: 2010-01-01
End date: 2011-09-26
Epogen
Dosage: 20000 iu, 3 times/wk
Start date: 2012-01-26
End date: 2012-02-22
Epogen
Dosage: 12000 iu, qwk
Start date: 2011-12-12
Epogen
Dosage: 10000 iu, 3 times/wk
Start date: 2009-07-08
End date: 2009-08-10
Epogen
Dosage: 15000 iu, 3 times/wk
Start date: 2012-01-21
End date: 2012-01-25
Other drugs received by patient: Lisinopril; Qvar 40; Venofer; Ceftriaxone; Vancomycin; Ceftazidime; Heparin; Metoprolol Tartrate; Ceftazidime; Vancomycin; Vancomycin; Proair HFA; Heparin; Renvela
Possible Epogen side effects in 84 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-27
Patient: 84 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Haemoglobin Decreased, Drug Ineffective, Anti-Erythropoietin Antibody Positive, Infection
Drug(s) suspected as cause:
Epogen
Dosage: 10000 unit, 3 times/wk
Start date: 2008-09-11
End date: 2008-10-09
Aranesp
Dosage: 300 mug, qwk
Indication: Renal Failure Chronic
Start date: 2011-11-30
End date: 2011-11-30
Epogen
Dosage: 30000 unit, 3 times/wk
Start date: 2009-06-04
End date: 2009-07-11
Epogen
Dosage: 22000 unit, 3 times/wk
Start date: 2009-03-05
End date: 2009-04-09
Epogen
Dosage: 14300 unit, 3 times/wk
Start date: 2012-01-07
Epogen
Dosage: 20000 unit, 3 times/wk
Start date: 2009-07-11
End date: 2009-07-11
Epogen
Dosage: 28000 unit, 3 times/wk
Start date: 2009-05-07
End date: 2009-06-04
Epogen
Dosage: 15000 unit, 3 times/wk
Start date: 2008-10-09
End date: 2008-11-13
Epogen
Dosage: 12000 unit, 3 times/wk
Start date: 2008-08-12
End date: 2008-09-11
Epogen
Dosage: 19000 unit, 3 times/wk
Start date: 2008-12-04
End date: 2009-01-13
Aranesp
Dosage: 300 mug, qwk
Indication: Anaemia
Start date: 2011-11-14
End date: 2011-11-30
Epogen
Dosage: 1500 unit, 3 times/wk
Start date: 2011-11-30
End date: 2011-12-19
Epogen
Dosage: 18000 unit, 3 times/wk
Start date: 2009-02-08
End date: 2009-03-05
Epogen
Dosage: 13000 unit, 3 times/wk
Start date: 2008-03-12
End date: 2008-04-10
Epogen
Dosage: 11000 unit, 3 times/wk
Start date: 2008-01-23
End date: 2008-03-12
Aranesp
Dosage: 300 mug, q2wk
Start date: 2011-10-10
End date: 2011-12-05
Aranesp
Dosage: unk
Start date: 2008-01-23
Epogen
Dosage: 1500 unit, 3 times/wk
Start date: 2011-12-19
End date: 2012-01-06
Epogen
Dosage: 15000 unit, 3 times/wk
Start date: 2009-01-13
End date: 2009-02-08
Epogen
Dosage: 18000 unit, 3 times/wk
Start date: 2008-11-13
End date: 2008-12-04
Epogen
Dosage: 9000 unit, 3 times/wk
Start date: 2008-04-10
End date: 2008-08-12
Other drugs received by patient: Ferrlecit; Reglan; Vitamin C / 00008001 /; Engerix-B; Engerix-B; Rena-Vite; Cipro; Hectorol; Hectorol; Ferrlecit; Fosrenol; Tylenol (Caplet); Sodium Chloride; Engerix-B; Metoprolol Succinate; Vancocin Hydrochloride; Levaquin; Hectorol; Venofer; Engerix-B; Engerix-B; Zemplar; Vancocin Hydrochloride; Vantin; Ferrlecit; Ferrlecit; Ferrlecit; Ferrlecit; Fosrenol; Benadryl; Tylenol (Caplet); Aspirin; Dextrose; Engerix-B; Ergocalciferol; Ergocalciferol; Vancomycin HCL; Influenza Virus Vaccine; Tuberculin NOS; Prilosec; Venofer; Cathflo Activase; Hectorol; Ferrlecit; Fosrenol; Engerix-B; Flagyl; Phoslo; Zemplar; Ergocalciferol; Ferrlecit; Bactrim; Hypertonic Saline Solution; Oxygen; Sodium Chloride; Ferrlecit; Ferrlecit; Benadryl; Vitamin B Complex CAP; Venofer; Sodium Chloride; Cholestyramine; Epinephrine; Ergocalciferol; Vancocin Hydrochloride; Tobramycin Sulfate; Tuberculin NOS
Possible Epogen side effects in 55 year old male
Reported by a physician from United States on 2012-02-29
Patient: 55 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Therapeutic Response Decreased, Anti-Erythropoietin Antibody Positive, Anaemia, Aplasia Pure RED Cell
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epogen
Start date: 2008-01-01
End date: 2010-09-15
Epogen
Dosage: unk unk, qwk
Indication: Renal Failure Chronic
Start date: 2008-12-16
End date: 2010-09-08
Epogen
Start date: 2008-01-01
End date: 2010-09-15
Epogen
Start date: 2008-01-01
End date: 2010-09-15
Other drugs received by patient: Calcium Carbonate; Dialyvite 3000; Amlodipine; Calcium Acetate; Lisinopril; Omeprazole
Possible Epogen side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-19
Patient: male
Reactions: Haemoglobin Decreased, Anti-Erythropoietin Antibody Positive, Drug Ineffective
Drug(s) suspected as cause:
Epogen
Dosage: unk
Epogen
Dosage: 15000 iu, 3 times/wk
Indication: Renal Failure Chronic
Aranesp
Dosage: 300 mug, q2wk
Indication: Renal Failure Chronic
Start date: 2011-10-10
End date: 2011-12-05
Other drugs received by patient: Ferrlecit; Bactrim; Fosrenol; Hectorol
Possible Epogen side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-19
Patient: male
Reactions: Haemoglobin Decreased, Drug Ineffective, Anti-Erythropoietin Antibody Positive
Drug(s) suspected as cause:
Epogen
Dosage: 15000 iu, 3 times/wk
Indication: Renal Failure Chronic
Epogen
Dosage: unk
Aranesp
Dosage: 300 mug, q2wk
Indication: Renal Failure Chronic
Start date: 2011-10-10
End date: 2011-12-05
Other drugs received by patient: Bactrim; Ferrlecit; Hectorol; Fosrenol
Possible Epogen side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-16
Patient: male
Reactions: Haemoglobin Decreased, Drug Ineffective, Anti-Erythropoietin Antibody Positive
Drug(s) suspected as cause:
Aranesp
Dosage: 300 mug, q2wk
Indication: Renal Failure Chronic
Start date: 2011-10-10
End date: 2011-12-05
Epogen
Dosage: 15000 iu, 3 times/wk
Indication: Renal Failure Chronic
Epogen
Dosage: unk
Other drugs received by patient: Fosrenol; Hectorol; Ferrlecit; Bactrim
Possible Epogen side effects in 39 year old male
Reported by a physician from United States on 2011-11-11
Patient: 39 year old male
Reactions: Anti-Erythropoietin Antibody Positive, Drug Ineffective
Drug(s) suspected as cause:
Epogen
Possible Epogen side effects in 85 year old male
Reported by a physician from Japan on 2011-10-03
Patient: 85 year old male, weighing 60.0 kg (132.0 pounds)
Reactions: Gastrointestinal Haemorrhage, Anti-Erythropoietin Antibody Positive, Dizziness Postural, Duodenal Ulcer, Aplasia Pure RED Cell
Drug(s) suspected as cause:
Pletal
Dosage: 100 mg milligram(s), bid, oral
Administration route: Oral
Start date: 2011-04-25
Epogen
Dosage: 3000 iu, tid, intravenous
Indication: Nephrogenic Anaemia
Start date: 2011-06-29
Lansoprazole
Dosage: 30 mg milligram(s), qd, oral 15 mg milligram(s), qd, oral
Administration route: Oral
Start date: 2011-09-07
Lansoprazole
Dosage: 30 mg milligram(s), qd, oral 15 mg milligram(s), qd, oral
Administration route: Oral
End date: 2011-08-08
Other drugs received by patient: Nesp (Darbepoetin); Micardis; Sodium Alginate Calcium Gluconate INJ; Oxarol (Maxacalcitol); Fosrenol (Lanthanum Carbonate Hydrate); Amlodin OD (Amlodipine Besilate); Cinal (Ascorbic Acid, Calcium Pantothenate); Promac (Polaprezinc)
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