Medication-specific REMS
There are currently FDA-approved REMS in place for all of the mycophenolic acid (MPA) medications (both brand and generic products). The mToR inhibitors also had FDA-approved REMS, but the manufacturers of these products were released from their REMS requirements by the FDA and there are no longer REMS associated with these medications. Some medications without indications in transplantation may also have a REMS in place, such as eculizumab. Despite using it off label in transplantation, REMS requirements must still be followed by transplant professionals using this medication. Below is a summary of the REMS elements for Belatacept and the MPA derivatives and some useful links. Back to REMS main page.
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MPA Derivatives
OBJECTIVE: To minimize fetal exposure to MPA, prevent unplanned pregnancies in patients using MPA, collect data on MPA use in pregnancy via the Mycophenolate Pregnancy Registry, and to education patients about the risks associated with the use of this medication.
ELEMENTS: Medication guide and ETASU
- The ETASU requirements include special training of healthcare providers who prescribe MPA in the form of the "Mycophenolate Program Brochure for Healthcare Providers”.
- This brochure contains:
- information on the risk of miscarriage and birth defects with the use of MPA
- information on the prevention of pregnancy with medically accepted forms of contraception and the importance of family planning for patients who are taking MPA
- information on how to decide whether to continue or initiate treatment with MPA in pregnant patients, by performing a risk-versus-benefit analysis
- Another aspect of the brochure includes encouraging prescribers to register patients in the Mycophenolate Pregnancy Registry and the importance of reporting outcomes of these pregnancies to the registry.
- The final component of the brochure involves informing the prescriber of the importance of having the patient sign the “Patient-Prescriber Acknowledgement Form”.
USEFUL LINKS:
- FDA-approved MPA REMS Information
- Manufacturer's REMS page (or call 1-800-617-8191)
- Mycophenolate mofetil Medication Guide
- Enteric-coated mycophenolic acid Medication Guide
- Mycophenolate Pregnancy Registry website
Eculizumab
OBJECTIVE: To minimize the risk of serious infection, in particular meningococcal infection and PML, and to ensure the proper use of the medication.
ELEMENTS: Medication guide and ETASU
- The ETASU includes prescriber certification based on an attestation that the prescriber will educate patients, provide them with a copy of the medication guide and comply with the directions for safe use (i.e. meningococcal vaccination, monitor patients for signs and symptoms of serious infections).
- All prescribers must enroll with the manufacturer.
- The manufacturer is responsible for providing education to certified prescribers annually, ensuring that eculizumab is distributed only to certified prescribers and that prescribers comply with the requirements of the REMS.
USEFUL LINKS:
REMS resource center content provided by Steven Gabardi, PharmD of Brigham and Women's and reviewed by Rita Alloway, PharmD, Diane Cibrik, MD, and Richard Formica, MD. This resource center was made possible in part by support from Bristol-Myers Squibb Company.