Epogen

[Epoetin alfa]

It is recommended that the dose of EPOGEN (r) be decreased if the hematocrit increase exceeds 4 points in any 2-week period, because of the possible association of excessive rate of rise of hematocrit with an exacerbation of hypertension. In CRF patients on hemodialysis with clinically evident ischemic heart disease or congestive heart failure, the hematocrit should be managed carefully, not to exceed 36% (see THROMBOTIC EVENTS).

Seizures

Seizures have occurred in patients with CRF participating in EPOGEN (r)
clinical trials. In adult patients on dialysis, there was a higher incidence of seizures during the first 90 days of therapy (occurring in approximately 2.5% of patients) as com-pared with later timepoints. Given the potential for an increased risk of seizures during the first 90 days of therapy, blood pressure and the presence of premonitory neurologic symptoms should be monitored closely.

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Patients should be cautioned to avoid potentially hazardous activities such as driving or operating heavy machinery during this period. While the relationship between seizures and the rate of rise of hematocrit is uncertain, it is recommended that the dose of EPOGEN (r) be decreased if the hematocrit increase exceeds 4 points in any 2-week period.

Thrombotic Events

During hemodialysis, patients treated with EPOGEN (r) may require increased anticoagulation with heparin to prevent clotting of the artificial
kidney (see ADVERSE REACTIONS for more information about thrombotic
events). Other thrombotic events (eg, myocardial infarction, cerebrovascular accident, transient ischemic attack) have occurred in clinical trials at an annualized rate of less than 0.04 events per patient year of EPOGEN (r) therapy.

These trials were conducted in adult patients with CRF (whether on dialysis or not) in whom the target hematocrit was 32% to 40%. However, the risk of thrombotic events, including vascular access thrombosis, was significantly increased in adult patients with ischemic heart disease or congestive heart failure receiving EPOGEN (r) therapy with the goal of reaching a normal hematocrit (42%) as compared to a target hematocrit of 30%. Patients with pre-existing cardiovascular disease should be monitored closely.

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