assays for binding and neutralizing antibodies. If erythropoietin
antibody-mediated anemia is confirmed, PROCRIT should be permanently
discontinued and patients should not be switched to other erythropoietic
-- 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).
-- In some female patients, menses have resumed following PROCRIT therapy;
the possibility of pregnancy should be discussed and the need for
-- Prior to and regularly during PROCRIT therapy monitor iron status;
transferrin saturation should be greater than or equal to 20% and
ferritin should be greater than or equal to 100 ng/mL. During therapy
absolute or functional iron deficiency may develop and all patients will
eventually require supplemental iron to adequately support
erythropoiesis stimulated by PROCRIT.
-- Treatment of patients with grossly elevated serum erythropoietin levels
(e.g., >200 mUnits/mL) is not recommended.
-- During PROCRIT therapy, blood pressure should be monitored carefully and
aggressively managed, particularly in patients with an underlying
history of hypertension or cardiovascular disease.
-- In studies, the most common side effects included fever (pyrexia),
diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or
loss of strength or weakness (asthenia, fatigue), shortness of breath,
high blood pressure, headache, joint pain (arthralgias), abnormal skin
sensations (as tingling or tickling or itching or burning; paresthesia),<
|SOURCE Ortho Biotech Products, L.P.|
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