Hema-Plus Adverse Reactions

Patients with chronic renal failure: Epoetin alfa is generally well tolerated; the adverse events reported are frequent sequel of chronic renal failure and are not necessarily attributable to Epoetin alfa use. In patients with chronic renal failure the most important side events reported from the clinical point of view are hypertension, seizures, thrombotic event, headache, increases of heart rate, nausea, vomiting and hypercalcemia.
Hypertension: Increases in blood pressure have been reported in clinical trials, often during the first 90 days of therapy. Data from clinical trial with Epoetin alfa showed a trend of more reports of hypertensive adverse event in patients on dialysis with a faster rate of rise of hematocrit (greater than 4 points). However in a double blind clinical trial with Epoetin alfa the incidence of hypertension was the same in group, the treated and the control.
Seizures: Seizures have been reported in clinical trials and with an incidence of 5% in patients on dialysis treated with erythropoietin. Even though this is a relatively low figure, there appears to be a higher rate of seizures during the first 90 days of therapy.
Thrombotic events: During hemodialysis, patients treated with Hema-Plus may require increased anticoagulation to prevent clotting of the artificial kidney.
A relationship has not been established with statistical significance between an increase in hematocrit and the rate of thrombotic events (including thrombosis of the vascular access). Clotting of the vascular access has occurred at an annual rate of about 0.25 events per patient-year, which is not greater than non-treated patients on dialysis treatment are.
Serious events of thrombo-embolism, including migratory thrombophlebitis, pulmonary embolus microvascular thrombosis and retinal thrombosis have rarely been observed in patients treated with erythropoietin. The overall frequency has been 0.0001 events per patient-year.
Allergic reactions: There have been no reports of serious allergic reactions or anaphylaxis associated with Epoetin alfa.
Cancer patients on chemotherapy: In this group of patients the following adverse reactions had been reported with an incidence of 10%: fever, diarrhea, vomiting, dizziness, and respiratory infections.
Although some statistically significant differences between patients treated with erythropoietin and placebo-controlled patients were found, the overall safety profile of the product proves to be consistent with the process of an advanced neoplastic disease.