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Janssen Products, LP Modifies Prescribing Information for PROCRIT® (Epoetin alfa) in Chronic Kidney Disease
Date:6/24/2011

ions [see Warnings and Precautions (5.1)].

The Warnings and Precautions section highlights state that "Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit." The section advises prescribers to use caution in patients with coexistent cardiovascular disease and stroke.

The Dosage and Administration section has been revised to include additional guidance to prescribers, as follows:

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.  No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.  Individualize dosing and use the lowest dose of PROCRIT sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)].  Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)].

For all patients with CKD:

When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly.  When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability.  A single hemoglobin excursion may not require a dosing change.

  • Do not increase the dose more frequently than once every 4 weeks.  Decreases in dose can occur more frequently.  Avoid frequent dose adjustments.
  • If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT by 25
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SOURCE Janssen Products, LP
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