Preventing the Preventable: Safe Mycophenolate Practices in Patients of Childbearing Potential

Mycophenolate-containing medications are widely used to prevent organ rejection in transplant recipients and to treat (off label) some autoimmune conditions such as lupus; however, use of these immunosuppressive agents during pregnancy is linked to a significantly increased risk of miscarriage and severe congenital malformations. Despite the U.S. Food and Drug Administration’s (FDA’s) Mycophenolate Risk Evaluation and Mitigation Strategy (MREMS) implemented in 2012, pregnancies among patients receiving ongoing treatment with mycophenolate have not substantially decreased.

In this CME Outfitters recorded webcast, expert faculty will discuss the latest evidence on the teratogenic risks of mycophenolate; share strategies for counseling patients before and during mycophenolate administration on appropriate pregnancy testing and acceptable contraception methods; and examine the critical role of the Mycophenolate Pregnancy Registry in supporting ongoing pharmacovigilance in confirmed pregnancies.

At the conclusion of this activity, learners will be able to better:

• Identify the teratogenic risks associated with mycophenolate use during pregnancy
• Counsel patients of childbearing potential before and during mycophenolate administration on appropriate pregnancy testing and acceptable contraception methods
• Monitor confirmed pregnancies for the Mycophenolate Pregnancy Registry to support ongoing pharmacovigilance

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).

Transplant specialists, OB/GYNs, rheumatologists, immunologists, PCPs, physician associates (PAs), nurse practitioners (NPs), nurses, and pharmacists

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. Girnita reports no financial relationships to disclose.

Dr. Kehasse reports no financial relationships to disclose.

Dr. Shah reports the following financial relationships:

Advisory Board: Outset Medical, Inc.

Consultant: Miller Medical Communications, LLC

Grants: National Institutes of Health (NIH)

The following individuals have no financial relationships to disclose:

Rebecca Vargas-Jackson, MD (Peer Reviewer)
Albert Eubanks, Jr., RN (Peer Reviewer)
Nichole Lainhart (Planning Committee)
Warren Beckman (Planning Committee)
Scott J. Hershman, MD, FACEHP, CHCP (Planning Committee)
Sandra Caballero, PharmD (Planning Committee)
Sharon Tordoff (Planning Committee)

*All identified conflicts of interest have been mitigated.

Unlabeled Use Disclosure
Faculty of this CME/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. CME Outfitters, LLC, the faculty, planners, and reviewers do not endorse the use of any product outside of the FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed during this activity without evaluation of their patient for contraindications or dangers of use.

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