Procrit - Warnings & Precautions

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In some female patients, menses have resumed following PROCRIT 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 PROCRIT. However, PROCRIT has not caused increased urinary excretion of porphyrin metabolites in normal volunteers, even in the presence of a rapid erythropoietic response. Nevertheless, PROCRIT should be used with caution in patients with known porphyria. In preclinical studies in dogs and rats, but not in monkeys, PROCRIT therapy was associated with sub-clinical bone marrow fibrosis. Bone marrow fibrosis is a known complication of CRF in humans and may be related to secondary hyperparathyroidism or unknown factors. The incidence of bone marrow fibrosis was not increased in a study of adult patients on dialysis who were treated with PROCRIT for 12-19 months, compared to the incidence of bone marrow fibrosis in a matched group of patients who had not been treated with PROCRIT.

Hematocrit in CRF patients should be measured twice a week; zidovudine-treated HIV-infected and cancer patients should have hematocrit measured once a week until hematocrit has been stabilized, and measured periodically thereafter. Lack or Loss of Response: If the patient fails to respond or to maintain a response to doses within the recommended dosing range, the following etiologies should be considered and evaluated:

1) Iron deficiency: Virtually all patients will eventually require supplemental iron therapy. (See "Iron Evaluation".)

2) Underlying infectious, inflammatory, or malignant processes.

3) Occult blood loss.

4) Underlying hematologic diseases (i. e., thalassemia, refractory anemia, or other myelodysplastic disorders).

5) Vitamin deficiencies: folic acid or vitamin B12.

6) Hemolysis.

7) Aluminum intoxication.

8) Osteitis fibrosa cystica.

In the absence of another etiology, the patient should be evaluated for evidence of PRCA and sera should be tested for the presence of antibodies to recombinant erythropoietins.