Mycophenolate mofetil

Safety advisory - new contraindications relating to pregnancy and breastfeeding

21 December 2015

Consumers and health professionals are advised that there has been an important safety update for mycophenolate mofetil, which is marketed in Australia as CellCept and various generic brands.

Mycophenolate mofetil is an immunosuppressant that is used to prevent the rejection of a transplanted organ.

This medicine is now contraindicated in the following situations:

  • during pregnancy
  • in women of childbearing potential who are not using two reliable forms of contraception (including at least one highly effective method)
  • in women who are breastfeeding.

This new safety information has been added to the Product Information (PI) for CellCept (and will soon be added to the PIs for generic brands). This medicine has been found to increase the risk of miscarriage and severe birth defects following exposure during pregnancy.

Additionally, sexually active men who are taking mycophenolate mofetil, including those who have had a vasectomy, are advised to use condoms during treatment and for at least 90 days after ending treatment. Female partners of such men are also advised to use a highly effective contraceptive during this time.

The contraindication in women who are breastfeeding is a precaution to prevent potential serious adverse reactions in nursing infants.

Information for consumers

You should not take mycophenolate mofetil if you:

  • are pregnant
  • could become pregnant and are not using two reliable forms of contraception
  • are breastfeeding.

If you are a woman of childbearing potential and you are taking mycophenolate mofetil, you should continue to use two reliable forms of contraception (including at least one highly effective method) for at least six weeks after ending treatment.

For men who are sexually active and are taking mycophenolate mofetil, including those who have had a vasectomy, you should use condoms during treatment and for at least 90 days after ending treatment. Your female partners are also advised to use a highly effective contraceptive during this time.

If you have any questions or concerns about this issue, speak to your health professional.

Information for health professionals

The sponsor of CellCept, Roche Products, has written to specialists and the relevant colleges providing further information about this issue.

If you are considering using mycophenolate mofetil in a patient of reproductive potential, either female and male, advise them of the increased risk of spontaneous abortion and congenital malformations associated with this medicine. Educate them regarding pregnancy prevention and planning.

Before starting treatment, female patients of childbearing potential must have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL. The second test should be performed 8-10 days after the first one and immediately before starting treatment. Repeat pregnancy tests should be performed during routine follow-up visits. Results of all pregnancy tests should be discussed with the patient.

Patients should be instructed to contact you immediately should they become pregnant.

Further information about this issue is available in the updated PI for CellCept.

If you have further questions or concerns about CellCept contact Roche Products on 1800 233 950 or email Australia.medinfo@roche.com.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.