FDA notified Amgen and Janssen that the ESA REMS requirement (which includes the ESA APPRISE
Oncology Program) has been removed for Aranesp®, EPOGEN® and PROCRIT®. ESA REMS assessments
have indicated that healthcare providers demonstrate acceptable knowledge of the product risks of
decreased survival and/or the increased risk of tumor progression or recurrence and that the product’s risks
can be conveyed adequately via the current product labeling, which includes the medication guide.
Prior to treatment, inform patients of the risks and benefits of ESAs as described in Section 17 Patient
Counselling Information of the USPI.
For product information about Aranesp or EPOGEN, contact Amgen Medical Information at (800) 772-6436.
For product information about PROCRIT, contact Janssen Medical Information Center at (800) 526-7736.