Approved Risk Evaluation and Mitigation Strategies (REMS)

Contact Us | REMS Basics | Gov Delivery Get REMS Email Alerts | Data Files

Epogen / Procrit (epoetin alfa)
BLA #103234
REMS last update: 12/31/2013

View the Epogen / Procrit Prescribing Information and Medication Guide at DailyMed.
View Epogen / Procrit's Regulatory Information at Drugs@FDA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the product-specific REMS website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Epogen/Procrit to patients with cancer

To be able to prescribe Epogen/Procrit
  • Review the prescribing information for Epogen/Procrit.
  • Complete the ESA APPRISE Oncology Program Training Module for Healthcare Providers, including the knowledge assessment.
  • Enroll in the REMS by completing and submitting the ESA APPRISE Oncology Program Enrollment Form for Healthcare Providers.
Before writing the first prescription for a patient
  • Counsel the patient on the risks of erythropoietin stimulating agent (ESA) therapy using the ESA APPRISE Oncology Program Patient and Healthcare Provider Acknowledgment Form.
  • Complete the ESA APPRISE Oncology Program Patient and Healthcare Provider Acknowledgment Form. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.
Before writing each prescription after the first prescription
  • Counsel the patient on the risks of ESA therapy using the ESA APPRISE Oncology Program Patient and Healthcare Provider Acknowledgment Form.
  • Complete the ESA APPRISE Oncology Program Patient and Healthcare Provider Acknowledgment Form. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.

Patients with cancer who receive Epogen/Procrit

To be able to receive Epogen/Procrit
  • Complete the ESA APPRISE Oncology Program Patient and Healthcare Provider Acknowledgment Form with the prescriber.
Before receiving the initial Epogen/Procrit prescription
  • Receive counseling from the prescriber on patient risks and benefits of Epogen/Procrit.

Hospitals or outpatient facilities affiliated with hospital/institution that dispense Epogen/Procrit to patients with cancer

To be able to dispense Epogen/Procrit
  • Designate an authorized representative to carry out the certification process on behalf of the healthcare setting.
  • Have the authorized representative complete the ESA APPRISE Oncology Program Training Module for Hospital Designees, including the knowledge assessment.
  • Establish processes and procedures to ensure that safe use conditions are met for patients with cancer.
  • Enroll in the REMS by completing and submitting the ESA APPRISE Oncology Program Enrollment Form for Hospitals.
Before dispensing Epogen/Procrit
  • Verify that the prescriber is certified and receipt of the ESA APPRISE Oncology Program Patient and Healthcare Provider Acknowledgment Form.
Ongoing
  • Maintain records of prescriber enrollment (ie, unique enrollment ID number) and the completed ESA APPRISE Oncology Program Acknowledgment Forms on-site and/or archiving them in a retrievable manner that does not require the disclosure of the patient’s medical record.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

Private-practice-based clinics that dispense Epogen/Procrit to patients with cancer

Ongoing
  • Maintain records of completed ESA APPRISE Oncology Program Acknowledgment Form for auditing purposes in a manner that does not require the disclosure of the patient’s medical record, and to store the Acknowledgment Forms on-site and/or archive them in a retrievable manner.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.