Epolitt Adverse Reactions

Summary of 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 as per published literature on another Epoetin alfa product, are diarrhea, 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.
Tabulated List of Adverse Reactions (as per published literature on another Epoetin alfa product), Of a total 3,262 subjects in 23 randomized, double-blinded, placebo or standard of care controlled studies, the overall safety profile of Epoetin alfa (Epolitt) was evaluated in 1,992 anaemic subjects. Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in predialysis [N=131 exposed CRF subjects] and 2 in dialysis [N=97 exposed CRF subjects]; 1,404 exposed cancer subjects in 16 studies of anemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; and 213 exposed subjects in 1 study in the perisurgical period. Adverse drug reactions reported by 1% of subjects treated with epoetin alfa in these trials are shown in the table as follows.
Frequency estimate: Very common (1/10), Common (1/100 to <1/10), Uncommon (1/1,000 to <1/100), Rare (1/10,000 to <1/1,000), Very Rare (<1/10,000), Not known (cannot be estimated from the available data). See table.

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Description of selected adverse reactions: Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angioneurotic edema 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. Antibody-mediated pure red cell aplasia has been very rarely reported in < 1/10,000 cases per patient year after months to years of treatment with Epoetin alfa (Epolitt).
Paediatric population with chronic renal failure on hemodialysis: The exposure of paediatric patients with chronic renal failure on hemodialysis in clinical trials and post marketing experience is limited. No paediatric-specific adverse reactions not mentioned previously in the table above, or any that were not consistent with the underlying disease were reported in this population.