Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annu... (Contact ORTHO BIOTECH (1-888-2ASKOBI or ...)

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Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting

Date:11/7/2008

Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-888-227-5624) to perform

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

proteins.

-- 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

contraception evaluated.

-- 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),

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