Eprex

Eprex Adverse Reactions

epoetin alfa

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Adverse Reactions
Summary of the Safety Profile: The most frequent adverse drug reaction during treatment with Epoetin alfa 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 drug reactions observed in clinical trials of Epoetin alfa are diarrhoea, nausea, vomiting, pyrexia, and headache. Influenza-like illness may occur especially at the start of treatment.
Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis.
An increased incidence of thrombotic vascular events (TVEs), has been observed in patients receiving ESAs (See Precautions).
Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reaction, and angio-oedema have been reported.
Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during Epoetin alfa 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 3559 subjects in 27 randomized, double-blinded, placebo or standard of care controlled studies, the overall safety profile of Epoetin alfa was evaluated in 2136 anemic subjects. Included were 228 Epoetin alfa-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)]; 1,404 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. Adverse drug reactions reported by ≥1% of subjects treated with Epoetin alfa in these trials are shown in the Table 6 (see Table 6).

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Post-Marketing Experience: Adverse drug reactions identified during the post-marketing experience with Epoetin α are listed as follows. The frequencies are provided according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000, including isolated reports).
Antibody-mediated pure red cell aplasia has been very rarely reported (<1/10,000 cases per patient-year) after months to years of treatment with Eprex. (See Table 7.)

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