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The updates include modifications to the Boxed Warning, Warnings and Precautions, Indications and Usage, and Dosage and Administration sections for CKD, which have been revised to clarify important new information based on the totality of clinical data when ESAs are used to increase hemoglobin (Hb) levels beyond labeled guidance.

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Indeed, they have enabled oncologists to give a greater therapeutic dose of chemotherapy than was previously possible because the bone marrow cells (which produce white blood cells, red blood cells and platelets) could be wiped out without these drugs resulting in serious anemia, infections, and other side effects.

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Additionally, the Dosage and Administration section for patients with CKD-associated anemia who are not on dialysis has been updated to provide indication-specific guidance to prescribers considering ESA treatment.

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