Mycophenolate mofetil: new pregnancy prevention advice

Mycophenolate mofetil and its active metabolite mycophenolic acid should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.

Women of childbearing potential should use two reliable forms of contraception simultaneously with mycophenolate mofetil therapy. | iStock
Women of childbearing potential should use two reliable forms of contraception simultaneously with mycophenolate mofetil therapy. | iStock

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).

Further information
View mycophenolate drug records
MHRA Drug Safety Update

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.

Contraception required

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.

Pregnancy testing

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.

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Already registered?
Sign in

MIMS Product Slides

Product overviews prepared by the MIMS team, in a handy slide format.

Click here

Slides are initiated, funded & reviewed by the companies specified.

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases