WELCOME TO THE MYCOPHENOLATE REMS (Risk Evaluation and Mitigation Strategy)

What is the Mycophenolate REMS?

The Mycophenolate REMS is a program to tell doctors, nurses, pharmacists and patients about the risks of taking mycophenolate during pregnancy. It was mandated by the Food and Drug Administration (FDA).

What are the risks of mycophenolate during pregnancy?

  • Higher risk of miscarriage in the first 3 months.
  • Higher risk that the baby will have birth defects.

Who should be informed about the Mycophenolate REMS?

     

What is the goal of the Mycophenolate REMS?

The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with the use of mycophenolate during pregnancy by:
  1. Educating healthcare providers on the following:
    • The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy.
    • The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
    • The need to report pregnancies to the Mycophenolate Pregnancy Registry.
  2. Informing females of reproductive potential who are prescribed mycophenolate about:
    • The increased risks of first trimester pregnancy loss and congenital malformations when taking mycophenolate during pregnancy.
    • The importance of pregnancy prevention and planning when taking mycophenolate.

What medications contain mycophenolate?

Mycophenolate Mofetil
CellCept® by Genentech USA, Inc.

Generic formulations by >>
Accord Healthcare, Inc.
Alkem Laboratories, Ltd.
Apotex Corp.
Jubilant Cadista Pharmaceuticals Inc.
Mylan Pharmaceuticals, Inc.
Strides Pharma Inc.
Roxane Laboratories, Inc.
Sandoz Incorporated.
Teva Pharmaceuticals USA, Inc.
Vintage Pharmaceuticals, LLC.
Mycophenolic Acid
Myfortic® by Novartis Pharmaceuticals Corporation.

Generic formulations by >>
Apotex Corp.
Mylan Pharmaceuticals, Inc.










*Females of reproductive potential include girls who have entered puberty and all women who have a uterus and have not passed through menopause.