Adult Patients
Three double-blind, placebo-controlled studies, including 244 patients with CKD on dialysis, were used to identify the adverse reactions to epoetin alfa. In these studies, the mean age of patients was 48 years (range: 20 to 80 years). One hundred and thirty-three (55%) patients were men. The racial distribution was as follows: 177 (73%) patients were white, 48 (20%) patients were black, 4 (2%) patients were Asian, 12 (5%) patients were other, and racial information was missing for 3 (1%) patients.
Two double-blind, placebo-controlled studies, including 210 patients with CKD not on dialysis, were used to identify the adverse reactions to epoetin alfa. In these studies, the mean age of patients was 57 years (range: 24 to 79 years). One hundred and twenty-one (58%) patients were men. The racial distribution was as follows: 164 (78%) patients were white, 38 (18%) patients were black, 3 (1%) patients were Asian, 3 (1%) patients were other, and racial information was missing for 2 (1%) patients.
The adverse reactions with a reported incidence of ≥ 5% in epoetin alfa-treated patients and that occurred at a ≥ 1% higher frequency than in placebo-treated patients are shown in the table below:
Table 3. Adverse Reactions in Patients with CKD on DialysisAdverse Reaction | Epoetin alfa-treated Patients (n = 148) | Placebo-treated Patients (n = 96) |
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Hypertension | 27.7% | 12.5% |
Arthralgia | 16.2% | 3.1% |
Muscle spasm | 7.4% | 6.3% |
Pyrexia | 10.1% | 8.3% |
Dizziness | 9.5% | 8.3% |
Medical Device Malfunction (artificial kidney clotting during dialysis) | 8.1% | 4.2% |
Vascular Occlusion (vascular access thrombosis) | 8.1% | 2.1% |
Upper respiratory tract infection | 6.8% | 5.2% |
An additional serious adverse reaction that occurred in less than 5% of epoetin alfa-treated dialysis patients and greater than placebo was thrombosis (2.7% epoetin alfa and 1% placebo) [see Warnings and Precautions (5.1)].
The adverse reactions with a reported incidence of ≥ 5% in epoetin alfa-treated patients and that occurred at a ≥ 1% higher frequency than in placebo-treated patients are shown in the table below:
Table 4. Adverse Reactions in Patients with CKD Not on DialysisAdverse Reactions | Epoetin alfa-treated Patients (n = 131) | Placebo-treated Patients (n = 79) |
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Hypertension | 13.7% | 10.1% |
Arthralgia | 12.2% | 7.6% |
Additional serious adverse reactions that occurred in less than 5% of epoetin alfa-treated patients not on dialysis and greater than placebo were erythema (0.8% epoetin alfa and 0% placebo) and myocardial infarction (0.8% epoetin alfa and 0% placebo) [see Warnings and Precautions (5.1)].