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Mycophenolate: Clinical Uses, Serious Risks

Premiere Date: Friday, October 21, 2022

This activity offers CE credit for:

  1. ABIM (MOC)
  2. Family Physicians (AAFP)
  3. Medicine (accme)
  4. Nursing (ANCC)
  5. Pharmacy (acpe)
  6. PA (aapa)
  7. Other

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
Note: Credit Is No Longer Available


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

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

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 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, PAs, NPs, nurses, pharmacists, and physicians specializing in transplant medicine, OB/GYN, surgery, rheumatology, immunology and cardiology

Credit Information

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.

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. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations.

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.

    Questions about this activity? Call us at 877.CME.PROS (877.263.7767).


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