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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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Important Safety Information

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

Chronic Renal Failure:
  • In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
  • 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.
  • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense PROCRIT® to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
  • 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® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

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


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

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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