Procrit - Patient Info

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Hypertension:

Hypertension, associated with a significant increase in hematocrit, has been noted rarely in cancer patients treated with PROCRIT. Nevertheless, blood pressure in patients treated with PROCRIT should be monitored carefully, particularly in patients with an underlying history of hypertension or cardio-vascular disease. Seizures: In double-blind, placebo-controlled trials, 3.2% (N= 2/ 63) of patients treated with PROCRIT and 2.9% (N= 2/ 68) of placebo-treated patients had seizures. Seizures in 1.6% (N= 1/ 63) of patients treated with PROCRIT occurred in the context of a significant increase in blood pressure and hematocrit from baseline values. However, both patients treated with PROCRIT also had underlying CNS pathology which may have been related to seizure activity.

Thrombotic Events:

In double-blind, placebo-controlled trials, 3.2% (N= 2/ 63) of patients treated with PROCRIT and 11.8% (N= 8/ 68) of placebo-treated patients had thrombotic events (e. g., pulmonary embolism, cerebrovascular accident). Growth Factor Potential: PROCRIT is a growth factor that primarily stimulates red cell production. However, the possibility that PROCRIT can act as a growth factor for any tumor type, particularly myeloid malignancies, cannot be excluded.

Surgery Patients

Thrombotic/ Vascular Events:

In perioperative clinical trials with orthopedic patients, the overall incidence of thrombotic/ vascular events was similar in Epoetin alfa and placebo-treated patients who had a pre-treatment hemoglobin of >10 to 13 g/ dL. In patients with a hemoglobin of >13 g/ dL treated with 300 U/ kg of Epoetin alfa, the possibility that PROCRIT treatment may be associated with an increased risk of postoperative thrombotic/ vascular events cannot be excluded.

In one study in which Epoetin alfa was administered in the perioperative period to patients undergoing coronary artery bypass graft surgery, there were seven deaths in the Epoetin alfa-treated groups (N= 126) and no deaths in the placebo-treated group (N= 56). Among the seven deaths in the Epoetin alfa-treated patients, four were at the time of therapy (between study day 2 and 8). The four deaths at the time of therapy (3%) were associated with thrombotic/ vascular events. A causative role of Epoetin alfa cannot be excluded (see "WARNINGS").