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Zidovudine-treated HIV-infected Patients In contrast to CRF patients, EPOGEN (r) therapy has not been linked to exacerba-tion of hypertension, seizures, and thrombotic events in HIV-infected patients. PRECAUTIONS Text Continues Below
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 occa-sionally observed concurrently with EPOGEN (r) therapy, no serious allergic or anaphylactic reactions were reported (see ADVERSE REACTIONS for more information regarding allergic reactions). The safety and efficacy of EPOGEN (r) therapy have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, or hypercoagulable disorders). In some female patients, menses have resumed following EPOGEN (r) therapy; the possibility of pregnancy should be discussed and the need for contraception evaluated. Hematology Exacerbation of porphyria has been observed rarely in patients with CRF treated with EPOGEN (r) . However, EPOGEN (r) has not caused increased urinary excre-tion of porphyrin metabolites in normal volunteers, even in the presence of a rapid erythropoietic response. Nevertheless, EPOGEN (r) should be used with caution in patients with known porphyria. In preclinical studies in dogs and rats, but not in monkeys, EPOGEN (r) therapy was associated with subclinical bone marrow fibrosis. Bone marrow fibrosis is a known complication of CRF in humans and may be related to secondary hyper-parathyroidism or unknown factors. The incidence of bone marrow fibrosis was not increased in a study of adult patients on dialysis who were treated with EPOGEN (r) for 12 to 19 months, compared to the incidence of bone marrow fibrosis in a matched group of patients who had not been treated with EPOGEN (r) . Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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