Mycophenolate and the risk of teratogenicity

04 May 2016
04 May 2016

In a March ‘Dear Doctor’ letter, Roche strengthened their advice on the use of mycophenolate mofetil (Cellcept®) in women of childbearing age and men. Mycophenolate is a known teratogen and is contraindicated during pregnancy.

The following recommendations were made:

  • Two negative pregnancy tests (8 to 10 days apart) must be obtained before the initiation of mycophenolate mofetil in women of childbearing potential. The second of these must be immediately before starting treatment
  • Repeat pregnancy tests should be performed throughout treatment
  • Women on mycophenolate mofetil must be on two effective forms of contraception during treatment, and for six weeks after stopping
  • Sexually active men on mycophenolate mofetil must use condoms during treatment and for at least 90 days after stopping (both reproductively competent and vasectomised men) and female partners should be on reliable contraception throughout this period (including the 90 days after stopping)