Mycophenolate mofetil and mycophenolic acid are associated with a high rate of serious birth defects (23–27% of live births in women exposed during pregnancy compared with 2–3% of live births in the overall worldwide population and approximately 4–5% of live births in transplant recipients receiving other immunosuppressants) and an increased risk of spontaneous abortion (45–49% of pregnant women exposed compared with 12–33% of those receiving other immunosuppressants).
Healthcare professionals should ensure that women and men taking mycophenolate are informed about the:
- risk of harm to a baby
- need for effective contraception
- need to plan for pregnancy and change treatment as necessary
- need to immediately notify their healthcare professional if there is a possibility of pregnancy.
Women of childbearing potential should use two forms of effective contraception during treatment and for 6 weeks after stopping treatment.
As a precautionary measure, men (including those who have had a vasectomy) should use condoms during treatment and for at least 90 days after stopping treatment.
Female partners of male patients treated with mycophenolate should use highly effective contraception during treatment and for 90 days after the last dose.
Treatment with mycophenolate should only be initiated in women of childbearing potential when there is a negative pregnancy test result.
Two serum or urine pregnancy tests with a sensitivity of at least 25mlU/ml are recommended. The second test should be performed 8–10 days after the first and immediately before starting treatment with mycophenolate. From then on pregnancy tests should be repeated as clinically required, for example if any gap in contraception is reported.