Eprex Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Eprex based on the comprehensive assessment of the available adverse event information. A causal relationship with Eprex cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Summary of the Safety Profile: The most frequent adverse reaction during treatment with Eprex is a dose-dependent increase in blood pressure or aggravation of existing hypertension. Monitoring of the blood pressure should be performed, particularly at the start of therapy.
The most frequently occurring adverse reactions observed in clinical trials of Eprex are diarrhea, nausea, vomiting, pyrexia, and headache. Influenza-like illness may occur especially at the start of treatment.
An increased incidence of TVEs, has been observed in patients receiving ESAs (see Precautions).
Hypersensitivity reactions, including cases of rash, (including urticaria, anaphylactic reaction, and angioedema have been reported.
Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during Eprex treatment in patients with previously normal or low blood pressure. Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal.
Clinical Trial Experience: Of a total 3714 subjects in 29 randomized, double-blinded, placebo or standard of care (SOC) controlled studies, the overall safety profile of Eprex was evaluated in 2238 anemic subjects. Included were 228 Eprex-treated CRF subjects in 4 chronic renal failure studies (2 studies in predialysis, N=131 exposed CRF subjects not yet on dialysis and 2 in dialysis N=97 exposed CRF subjects on dialysis); 1404 exposed cancer subjects in 16 studies of anemia due to chemotherapy; 144 exposed subjects in 4 HIV-infection studies; 147 exposed subjects in 2 studies for autologous blood donation; and 213 exposed subjects in 1 study in the perisurgical setting, and 102 exposed subjects in 2 studies in MDS. Adverse reactions reported by ≥1% of subjects treated with Eprex in these trials are shown in the table as follows: (See Table 7.)

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Postmarketing Data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience (Table 8). In the table, the frequencies are provided according to the following convention: Very common ≥ 1/10, Common ≥ 1/100 and < 1/10, Uncommon ≥ 1/1,000 and < 1/100, Rare ≥ 1/10,000, < 1/1,000, Very rare < 1/10,000, including isolated reports.
Antibody-mediated PRCA has been very rarely reported (< 1/10,000 cases per patient-year) after months to years of treatment with Eprex. (See Table 8.)

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