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U.S. Department of Health and Human Services

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Questions and Answers: FDA Approves a Single Shared Risk Evaluation and Mitigation Strategy (REMS) for Mycophenolate-containing Medicines

On September 25, 2012 the U.S. Food and Drug Administration (FDA) 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.

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.

  • Complete information can be found at: www.MycophenolateREMS.com

  • Information about the pregnancy registry is available at: www.MycophenolatePregnancyRegistry.com 


The following questions and answers provide an overview of the “Mycophenolate REMS” program. 

Q1. What are mycophenolate-containing medicines?

Q2. What is a Risk Evaluation and Mitigation Strategy (REMS)?

Q3. What is the patient’s role in the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) program?

Q4. What should prescribers and other health care professionals know about the goals of the shared Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) program?

Q5. Why did FDA require a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate-containing medicines?

Q6. Will this action make it harder for patients to receive their mycophenolate-containing medicines?

Q7. What are the components of the shared Mycophenolate Risk Evaluation and Mitigation Strategy (REMS)?

Q8. Is the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) training mandatory for prescribers? Is a negative pregnancy test result required before dispensing the mycophenolate-containing medicines?

Q9. Why did FDA approve a single, shared system Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate-containing medicines?

Q10. When does the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) program “go live” or become fully operational?

 

Q1. What are mycophenolate-containing medicines?

A. Mycophenolate-containing medicines are in a class of medications called immunosuppressive agents. They work by weakening the body's immune system so it will not attack and reject a transplanted organ. The current list of mycophenolate-containing medicines includes CellCept (mycophenolate mofetil available as an oral capsule, oral tablet, oral suspension, injection), Myfortic (mycophenolic acid available as an oral delayed-release tablet), and any generic mycophenolate mofetil or mycophenolic acid products. Mycophenolate mofetil (CellCept and its generics) is used with other immunosuppressive medicines to help prevent rejection of the transplanted organ in people who have received a kidney, heart, or liver transplant. Mycophenolic acid (Myfortic and its generics) is used with other immunosuppressive medicines to help prevent rejection of the transplanted organ in people who have received a kidney transplant.


Q2. What is a Risk Evaluation and Mitigation Strategy (REMS)?

A. A REMS is a risk management plan that goes beyond requirements in the drug prescribing information to manage serious risks associated with a drug. Under the Food and Drug Administration Amendments Act of 2007, FDA has the authority to require a manufacturer to develop a REMS when further measures are needed to ensure that the drug’s benefits outweigh its risks.


Q3. What is the patient’s role in the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) program?

A. At this time, the primary focus of the Mycophenolate REMS is women who can get pregnant. If you are thinking about having a baby, talk with your doctor right away. 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. Because of these risks, it is important to tell your doctor right away if you are thinking about having a baby or becoming pregnant. You and your prescriber will decide together if mycophenolate treatment should be continued or stopped based on the benefits of continuing treatment and risks to the unborn baby.

In addition, 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.


Q4. What should prescribers and other health care professionals know about the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) program?

A. 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 (www.MycophenolateREMS.com) 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.

Additional information about the REMS program can be found on the Mycophenolate REMS website: www.MycophenolateREMS.com. Information about the pregnancy registry is available at: www.MycophenolatePregnancyRegistry.com.

More complete information regarding the use of mycophenolate-containing medicines can be found in the CellCept and Myfortic drug labels.
 

Q5. Why did FDA require a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate-containing medicines?

A. 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.


Q6. Will this action make it harder for patients to receive their mycophenolate-containing medicines?

A. FDA understands how important it is for patients to have access to immunosuppressive medicines to prevent rejection of transplanted organs, and FDA does not expect that the Mycophenolate REMS will affect patient access to mycophenolate-containing medicines.


Q7. What is included in the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS)?

A. The Mycophenolate REMS includes:

  • An education program for prescribers
    The central component of the Mycophenolate REMS is an education program for prescribers (e.g., physicians, nurse practitioners, physician assistants). Prescriber training includes information about the risk of first trimester pregnancy loss (miscarriage) and congenital malformations (birth defects), acceptable birth control options for patients, pregnancy testing recommendations, and the importance of counseling patients about the risks and the need for careful pregnancy prevention and planning. In addition, training includes information about the Mycophenolate REMS Call Center as well as how patients may participate in the Mycophenolate Pregnancy Registry.

  • The Mycophenolate REMS also includes two educational tools to facilitate prescribers’ counseling of patients.
    The first is a REMS Overview for Patients written in consumer-friendly language explaining the risks of miscarriage and birth defects if mycophenolate-containing medicines are taken during pregnancy and the patient’s role in the program. The second educational tool is the Patient-Prescriber Acknowledgement form to help to ensure that the prescriber counsels the patient and the patient understands the risks and appropriate safe use strategies.

  • A Medication Guide
    Patients will receive a Medication Guide, which contains consumer-friendly information about mycophenolate-containing medicines, from their pharmacist when they pick up their prescription.

  • A registry for females who become pregnant and consent to participate
    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.


Q8. Is the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) training mandatory for prescribers? Is a negative pregnancy test result required before dispensing the mycophenolate-containing medicines?

A. 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.

Requiring such linkages of program requirements to dispensing has the potential to delay therapy. The risk of delaying or not receiving immunosuppressive medicines, such as mycophenolate-containing medicines, in these patients is loss of the transplanted organ and potentially death. In addition, the woman and her doctor will decide together if treatment with mycophenolate-containing medicines should be continued or stopped based on the risks and benefits of continuing treatment, including the risks to the unborn baby.

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.

Q9. Why did FDA approve a single, shared system Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate-containing medicines?

A. 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.

Q10. When was the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) program approved?

A. The Mycophenolate REMS was approved on September 25, 2012. Additional information about the Mycophenolate REMS can be found at www.MycophenolateREMS.com.