Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annu... (administerederythropoiesis-stimulating a...)

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

Date:11/7/2008

administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

-- ESAs shortened overall survival and/or increased the risk of tumor

progression or recurrence in some clinical studies in patients with

breast, non-small cell lung, head and neck, lymphoid, and cervical

cancers (see WARNINGS: Table 1).

-- To decrease these risks, as well as the risk of serious cardio- and

thrombovascular events, use the lowest dose needed to avoid red blood

cell transfusion.

-- Use ESAs only for treatment of anemia due to concomitant

myelosuppressive chemotherapy.

-- ESAs are not indicated for patients receiving myelosuppressive therapy

when the anticipated outcome is cure.

-- Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT (Epoetin alfa) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

Contraindications

-- PROCRIT is contraindicated in patients with uncontrolled hypertension or

with known hypersensitivity to albumin (human) or mammalian cell-derived

products.

Additional Important Safety Information

-- Patients with chronic renal failure experienced greater risks for death

and serious cardiovascular events (including myocardial infarction,

stroke, congestive heart failure, and hemodialysis vascular access

thrombosis) when administered ESAs to target higher versus lower

hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical

studies; these risks also increased in controlled cl
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Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annu...(administerederythropoiesis-stimulating a...),Health