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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. 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 PROCRIT be decreased if the hematocrit increase exceeds 4 points in any two-week period. Thrombotic Events: During hemodialysis, patients treated with PROCRIT may require increased anti-coagulation with heparin to prevent clotting of the artificial kidney. (See "ADVERSE REACTIONS" for more information about thrombotic events.) Other thrombotic events (e. g., 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 PROCRIT therapy. Text Continues Below
These trials were conducted in patients with CRF (whether on dialysis or not) in whom the target hematocrit was 32-40%. However, the risk of thrombotic events, including vascular access thromboses, was significantly increased in adult patients with ischemic heart disease or congestive heart failure receiving PROCRIT 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. Zidovudine-Treated HIV-Infected Patients In contrast to CRF patients, PROCRIT therapy has not been linked to exacerbation of hypertension, seizures, and thrombotic events in HIV-infected patients. PRECAUTIONS The parenteral administration of any biologic product should be attended by appropriate precautions in case allergic or other untoward reactions occur (see "CONTRAINDICATIONS"). In clinical trials, while transient rashes were occasionally observed concurrently with PROCRIT therapy, no serious allergic or anaphylactic reactions were reported. (See "ADVERSE REACTIONS" for more information regarding allergic reactions.) The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (e. g., sickle cell anemia, myelodysplastic syndromes, or hypercoagulable disorders). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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