Mycophenolate: Clinical Uses, Serious RisksPremiere Date: Friday, October 21, 2022
This activity offers CE credit for:%>
- ABIM (MOC)
- Family Physicians (AAFP)
- Medicine (accme)
- Nursing (ANCC)
- Pharmacy (acpe)
- PA (aapa)
All other clinicians will receive a Certificate of Attendance stating this activity was certified for AMA PRA Category 1 Credit™
Credit Expiration Date:
Saturday, October 21, 2023
|Steven Gabardi, PharmD, BCPS, FAST, FCCP
Abdominal Organ Transplant Clinical Specialist
Brigham and Women's Hospital
Assistant Professor of Medicine
Harvard Medical School
|Miae Kim, PharmD, MS, BCPS
Clinical Pharmacy Specialist
Center for Advanced Heart Disease
Brigham and Women's Hospital
Mycophenolate is a highly effective immunosuppressant that is approved by the U.S. Food and Drug Administration (FDA) for prophylaxis against organ rejection in renal, cardiac, and hepatic transplants. It is also commonly prescribed for off-label use in other types of transplants as well as some autoimmune conditions. However, in addition to its utility as an immunosuppressant, it is also a known teratogen associated with first trimester pregnancy loss as well as congenital malformations. To mitigate the risk posed when treating patients of reproductive potential with mycophenolate, the FDA created the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) system with the goal of addressing persistent educational gaps for clinicians and patients on the safe use of these agents.
In part one of this CME Outfitters Snack series, Dr. Miae Kim joins host/moderator Dr. Steven Gabardi to discuss how mycophenolate works in the body, the potential for first trimester pregnancy loss, and the types of congenital malformations that can occur if the mycophenolate REMS is not followed.
References: 1. Kim M, Rostas S, Gabardi S. Mycophenolate fetal toxicity and risk evaluation and mitigation strategies. Am J Transplant. 2013;13(6):1383-1389. 2. Mycophenolate REMS: Risks of first trimester pregnancy loss and congenital malformations. Mycophenolate REMS website. https://www.mycophenolaterems.com/#Main. Published 2021. Accessed August 5, 2022.
At the end of this CE activity, participants should be able to:
- Evaluate the pregnancy and fetal risks related to mycophenolate use.
This activity is supported by an independent educational grant from the Mycophenolate REMS Group. This activity is intended to be fully compliant with the Mycophenolate REMS education requirements issued by the U.S. Food and Drug Administration (FDA).
Primary care physicians, PAs, NPs, nurses, pharmacists, and physicians specializing in transplant medicine, OB/GYN, surgery, rheumatology, immunology and cardiology
AAFP Credit (Family Physicians):
The AAFP has reviewed Mycophenolate: Clinical Uses, Serious Risks and deemed it acceptable for up to 0.50 Enduring Materials, Self-Study AAFP Prescribed credits. Term of Approval is from 10/11/2022 to 10/11/2023. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.5 medical knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.
Royal College MOC:
Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “CME in Support of MOC” program in Section 3 of the Royal College’s MOC Program.
MIPS Improvement Activity:
This activity counts towards MIPS Improvement Activity requirements under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Clinicians should submit their improvement activities by attestation via the CMS Quality Payment Program website.
Dr. Gibardi reports no financial relationships to disclose.
Dr. Kim reports no financial relationships to disclose.
The following peer reviewer and CME Outfitters staff have no financial relationships:
Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices.
Questions about this activity? Call us at 877.CME.PROS (877.263.7767).