Mycophenolate: Clinical Uses, Serious Risks

This activity is part of a series


Steven Gabardi, PharmD, BCPS, FAST, FCCP
Abdominal Organ Transplant Clinical Specialist, Brigham and Women's Hospital
Assistant Professor of Medicine, Harvard Medical School, Boston, MA
Steven Gabardi, PharmD, BCPS, FAST, FCCP

Steven Gabardi, PharmD, BCPS, FAST, FCCP, is a clinical specialist in organ transplant with the Department of Transplant Surgery at Brigham and Women’s Hospital in Boston, MA. He is also an Assistant Professor of Medicine at Harvard Medical School, where he became the first PharmD to receive an academic appointment. Dr. Gabardi earned his PharmD at Butler University?s College of Pharmacy and Health Sciences in Indianapolis, IN in 1999 and subsequently completed his residency in pharmacy practice at Tufts Medical Center in Boston, MA in 2000. After completing his residency, he was hired as a co-funded faculty member at Northeastern University’s Bouvé College of Health Sciences. His clinical practice site was at the Brigham and Women’s Hospital Division of Renal Transplant working in both the inpatient and outpatient settings.

Board-certified as a Pharmacotherapy Specialist and a Fellow of both the American Society of Transplantation and American College of Clinical Pharmacy, Dr. Gabardi has published in a multitude of textbooks and peer-reviewed journals. He has been invited to speak at local, national, and international conferences on many different transplant-related topics. Dr. Gabardi became the first transplant pharmacist to be named an Associate Editor for both the American Journal of Transplantation and Transplantation. He is also an editorial board member for several other peer-reviewed journals.

Miae Kim, PharmD, MS, BCPS
Clinical Pharmacy Specialist
Center for Advanced Heart Disease
Brigham and Women's Hospital
Boston, MA
Miae Kim, PharmD, MS, BCPS

Miae Kim, PharmD, MS, BCPS, received a master’s degree in Clinical Pharmacy from Seoul National University in South Korea, then moved to the U.S. where she graduated Summa Cum Laude with high distinction from the University of Minnesota with a PharmD. She completed her PGY-1 pharmacy practice training at Beth Israel Deaconess Medical Center, and did a PGY-2 training in solid organ transplant at Brigham and Women?s Hospital in Boston. Dr. Kim joined the Center for Advanced Heart Disease at Brigham and Women’s Hospital as a heart transplant/MCS pharmacy specialist in 2013, working in both the inpatient and outpatient settings. She attained board certification as a Pharmacotherapy Specialist in 2013. Dr. Kim’s current interests include cardiac transplant complications, antibody-mediated rejection, and cardiac allograft vasculopathy, and she has published in multiple peer-reviewed journals and textbooks and presented at local, national, and international transplant conferences.

Statement of Need

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. Published 2021. Accessed August 5, 2022.

Learning Objectives

At the end of this CME/CE activity, participants should be able to evaluate the pregnancy and fetal risks related to mycophenolate use.

Financial Support

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).

Target Audience

Primary care physicians, physician associates (PAs), nurse practitioners (NPs), nurses, pharmacists, and physicians specializing in transplant medicine, OB/GYN, surgery, rheumatology, immunology and cardiology

Credit Information

Jointly Accredited Provider

In support of improving patient care, CME Outfitters, LLC, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Interprofessional (IPCE) 0.5

This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) Credit for learning and change.

Physicians (ACCME) 0.5

CME Outfitters, LLC, designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses (ANCC) 0.5

This activity is designated for 0.5 contact hours.

Note for California Nurses

This continuing nursing education activity was approved by the California Board of Registered Nursing. CME Outfitters, LLC’s provider number is CEP15510.

Pharmacists (ACPE) 0.5

This application-based activity is approved for 0.5 contact hours (0.05 CEUs) of continuing pharmacy credit.
Activity UAN: JA0007185-0000-22-155-H01-P

PAs (AAPA) 0.5

CME Outfitters, LLC, has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.5 AAPA Category 1 CME credits. Approval is valid until expiration date listed above. PAs should only claim credit commensurate with the extent of their participation.

Family Physicians (AAFP) 0.5

The AAFP has reviewed the activity and deemed it acceptable for up to 0.50 Enduring Materials, Self-Study AAFP Prescribed credits. Term of Approval expires with the expiration date of the credit availability. Physicians should claim only the credit commensurate with the extent of their participation in the activity. AAFP Prescribed credit is accepted by the American Medical Association as equivalent to AMA PRA Category 1 Credit™ toward the AMA Physician's Recognition Award. When applying for the AMA PRA, Prescribed credit earned must be reported as Prescribed, not as Category 1.


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.

MIPS Improvement Activity

Completion of this accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA_PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Clinicians should submit their improvement activities by attestation via the CMS Quality Payment Program website.

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.

Disclosure Declaration

It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CE activity. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process.

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:

  • Thomas Heinrich, MD (peer reviewer)
  • Morgan Stockberger, MD (planning committee)
  • Warren Beckman (planning committee)
  • Susan H. Yarbrough, CHCP (planning committee)
  • Sandra Caballero, PharmD (planning committee)
  • Sharon Tordoff (planning committee)

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.

Obtaining Credits

Post-tests, credit request forms, and activity evaluations must be completed online (requires free account activation), and participants can print their certificate or statement of credit immediately (75% pass rate required). This website supports all browsers except Internet Explorer for Mac. For complete technical requirements and privacy policy, visit our Privacy & Confidentiality page.

Questions about this activity?

Call us at (877) CME-PROS or (877) 263-7767.




Mycophenolate: Clinical Uses, Serious Risks
Event Date: 10/21/2022