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Black Box Warnings .
Increased Mortality and Serious Cardiovascular Events in CKD Pts
incr. risk of death and serious cardiovascular events when administered to target Hgb >11 g/dL; no trial has identified Hgb target level, ESA dose, or dosing strategy that does not incr. these risks; use lowest dose sufficient to decr. need for RBC transfusion
Increased Mortality and/or Tumor Progression in Cancer Pts
use only for chemo-related anemia in pts where cure not anticipated outcome; incr. mortality and/or tumor progression or recurrence risk seen in pts w/ breast, head/neck, lymphoid, cervical, and non-small cell lung CA; use lowest dose needed to avoid RBC transfusion, D/C once chemo course completed