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If you're a patient on PROCRIT®
it's important you talk to your physician. New safety information has been released that you should be aware of. For further information, read the Medication Guide and Patient Instructions for Use.

Healthcare Professional >

If you're a physician prescribing PROCRIT there is new safety information that could affect your patients. For safety information, full prescribing information, including Boxed WARNINGS, please click here

Product Alerts
Voluntary Product Recall Notice
(August 2008)
Voluntary Product Withdrawal Notice
(May 2008)

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WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Renal failure:  Patients experienced greater risks for death and serious cardiovascular events when 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.

(See WARNINGS:  Increased Mortality, Serious Cardiovascular and Thromboembolic Events, WARNINGS:  Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)

           Please see Full Prescribing Information, including Boxed WARNINGS for more details.

           Medication Guide for PROCRIT
           Please read the Medication Guide for PROCRIT and discuss with your doctor.

           Patient Instructions for Use
           Instructions if you or your caregiver has been trained to give PROCRIT injections at home.

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