Life Science Compliance Update

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November 08, 2012

FDA REMS: Mycophenolate Class Wide REMS

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Over the past few months, we have seen increased activity at the Food and Drug Administration (FDA) with respect to the issuance and use of Risk Evaluation and Mitigation Strategy (REMS).  Consequently, FDA recently approved a single, shared system Risk Evaluation and Mitigation Strategy (REMS) for all mycophenolate-containing prescription medicines.  The drug mycophenolate is in a class of medications called immunosuppressive agents. It works by weakening the body's immune system so it will not attack and reject a transplanted organ. 

A REMS is a risk management plan that goes beyond requirements in the drug prescribing information to manage serious risks associated with a drug.  The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require companies to develop and implement a REMS when necessary to ensure that the benefits of a drug or biological product outweigh its risks.   

Mycophenolate-containing medicines are associated with an increased risk of first trimester pregnancy loss (miscarriage) and congenital malformation (birth defects) if taken during pregnancy.  To prevent unplanned pregnancies in patients using mycophenolate-containing medicines and to minimize fetal exposure to mycophenolate, FDA and the mycophenolate product manufacturers developed a single, shared system called the “Mycophenolate REMS.”   

The Mycophenolate REMS includes a Medication Guide, training for health care professionals, and the establishment of a pregnancy registry for women who become pregnant and agree to participate in the registry.  The training for health care professional’s component will likely require continuing medical education (CME) for physicians.   

The primary focus of the Mycophenolate REMS is women who can get pregnant. Women who can get pregnant should be aware of the risk of first trimester pregnancy loss (miscarriage) and an increased risk that the baby will be born with birth defects (congenital malformations) if mycophenolate-containing medicines are taken during pregnancy.  FDA stated that women who can get pregnant should follow these steps: 

  • Talk with their prescriber about use of mycophenolate-containing medicines and the risk of pregnancy loss or birth defects.
  • Use acceptable forms of birth control at all times during treatment and for six weeks after stopping mycophenolate-containing medicines. Decide with their prescriber what birth control methods are right for them.
  • Have a pregnancy test immediately before starting mycophenolate-containing medicines and another pregnancy test eight to ten days later. Pregnancy tests should be repeated during routine follow-up office visits with the prescriber. 

If a woman does get pregnant while taking mycophenolate-containing medicines, she should consider participating in the Mycophenolate Pregnancy Registry.
The goals of the mycophenolate REMS are to:

  1. Prevent unplanned pregnancy in patients using mycophenolate and to minimize fetal exposure by informing prescribers and females of reproductive potential about:
    • the increased risk of first trimester pregnancy loss and congenital malformation associated with exposure to mycophenolate during pregnancy; and
    • the importance of pregnancy prevention and planning
  2. Minimize the risks associated with fetal exposure to mycophenolate by collecting information on pregnancy outcomes through the Mycophenolate Pregnancy Registry
  3. Inform patients about the serious risks associated with mycophenolate. 

Health care professionals who prescribe mycophenolate-containing medicines will receive training materials from the Mycophenolate REMS Program and then can complete a “Training Confirmation” form (online or paper).  Mycophenolate manufacturers will maintain a list of all health care professionals who have completed the Mycophenolate REMS training.  FDA will periodically monitor participation by reviewing sponsors’ REMS assessments.  Mycophenolate manufacturers will redistribute training materials and update the Mycophenolate REMS website every two years or following substantive changes that affect the Mycophenolate REMS. 

A Medication Guide, which explains information about mycophenolate-containing medicines in consumer-friendly language, must be dispensed with each prescription.

Mycophenolate manufacturers will maintain a pregnancy registry for females who become pregnant while taking mycophenolate-containing medicines (or within six weeks of stopping treatment) and consent to participate. 

A REMS for mycophenolate-containing medicines was required by FDA due to receipt of postmarketing reports showing that exposure to mycophenolate during pregnancy is associated with increased risk of first trimester pregnancy loss (miscarriage) and birth defects (congenital malformations).  Structural malformations occur in approximately 20% of live-born infants exposed in utero to mycophenolate-containing medicines and first trimester pregnancy loss rates are increased.  While this information was included in the drug label starting in 2008, reports of pregnancy loss and birth defects continue to be reported.  The REMS was created to ensure that patients and prescribers are educated about these risks and understand what steps to take to prevent or minimize these risks. 

At this time, the Mycophenolate REMS will not require healthcare professionals to complete the training program in order to prescribe mycophenolate-containing medicines.  While the label of mycophenolate-containing products recommends pregnancy testing, the Mycophenolate REMS will not require that documentation of a negative pregnancy test be a requirement for dispensing mycophenolate-containing medicines. 

FDA reached this decision after carefully considering the risk of pregnancy loss and birth defects (teratogenicity risk), the drug’s benefits, the prescriber and patient populations who use mycophenolate-containing medicines, and the burden on patient access and the health care delivery system.

Since mycophenolate-containing products are marketed by several different sponsors, FDA requested that a single Mycophenolate REMS program be used and shared by all of these sponsors to reduce the burden on the health care system of having separate REMS programs in place for individual mycophenolate-containing medicines.  Having a single, shared system REMS for all of the products will make it easier for prescribers to participate in the REMS program because there will only be one education program for prescribers.  The manufacturers will maintain a single call center to support health care professionals and the REMS program.  The sponsors will also maintain a single pregnancy registry for females who become pregnant and consent to participate.

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The first trimester is very crucial period of the pregnancy, where there are huge chances of miscarriage and birth defects, so one should take well care of this period to avoid the risks.

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