Mycophenolate and pregnancy: Information for men and women

Why have you been given this leaflet?

You have been given this leaflet because you are currently prescribed or are due to be started on a medication containing mycophenolate. These include mycophenolic acid, sometimes called Myfortic and mycophenolate mofetil, sometimes called Cellcept.

Mycophenolate is widely prescribed to prevent transplant rejection as well as other auto-immune diseases.

There is some important information you need to be aware of regarding pregnancy or fathering a child whilst taking mycophenolate.

It is known that mycophenolate products can cause birth defects in the unborn babies of mothers taking mycophenolate. Approximately one in four children born to women who are taking mycophenolate will have a birth defect and up to half of pregnant women taking mycophenolate will have a miscarriage. Both of these figures are much higher in women taking mycophenolate compared with women taking other medication to prevent rejection or not taking mycophenolate.

Advice for female patients taking mycophenolate

For female transplant patients we recommend that you wait one to two years after your transplant before trying for a family so that your transplant is well established and you are on the lowest possible dose of medication. If you are taking mycophenolate for an auto-immune disease you should wait until your disease is in remission.

You are advised not to become pregnant whilst taking mycophenolate. It is recommended that you use reliable contraception whilst taking mycophenolate and for 6 weeks after your last mycophenolate dose so you do not have an unplanned pregnancy. Long acting reversible contraceptives (LARCs) are preferred, these are methods that don’t depend on you remembering to take or use them to be effective.

Condoms are not considered reliable.

If you are thinking about having a baby, do not stop using contraception until you have spoken to your consultant. This allows the kidney team to review your medication and provide advice specific to you.

If you discover that you are pregnant whilst taking mycophenolate it is important that you continue to take your medication until you have been reviewed by your consultant or a member of the kidney team. You should contact your consultant or a member of the kidney team urgently to discuss this.

When you start mycophenolate you will be offered a pregnancy test to confirm that you are not pregnant.

You must not donate blood whilst taking mycophenolate or for six weeks after stopping treatment.

Advice for male patients taking mycophenolate

The advice for male patients who are planning a family and taking mycophenolate has recently been updated.

It is now recommended that when having sex with a woman who could become pregnant either you or your partner should use a reliable form of contraception. This advice should be followed whilst you are taking mycophenolate and for 90 days after you have stopped this medicine.

Female partners of male patients taking mycophenolate are advised to use a reliable form of contraception during treatment and for 90 days after the last dose.

You must not donate sperm during therapy or for 90 days after your last dose of mycophenolate.

If you are planning a family please discuss this when you attend clinic. This allows the kidney team to review your medication and provide advice specific to you. It is important that you do not stop your medication without contacting the kidney team.

There are two theoretical concerns relating to men taking mycophenolate. The first theoretical concern that mycophenolate may affect your sperm leading to a risk of birth defects. The second theoretical concern is that mycophenolate in your semen may expose your partner to similar risks seen in women taking the drug.

It is important you understand that the advice for male patients is based on a theoretical risk and recommendations are precautionary. Current published evidence is that outcomes of pregnancies where the father is taking mycophenolate are similar to those of the general population.

At present there is no pattern of birth defects in the children of men who were taking mycophenolate at conception.

If you are taking mycophenolate and wish to father a child, these theoretical risks should be discussed with your kidney team. Alternative medicine may increase your risk of rejection or worsen your kidney disease.

You must not donate blood whilst taking mycophenolate or for six weeks after stopping treatment.

For more information

If you have any questions or concerns about the information in this leaflet please speak to your kidney consultant, specialist nurse or pharmacist.

A specialist renal pre pregnancy counselling service is available. This can be accessed by contacting a member of the renal team.

Additional information can be found in the patient information provided with your medication.

More in depth patient information about medication in pregnancy can be accessed: www.medicinesinpregnancy.org/About-Us/

If you or the individual you are caring for need support reading this leaflet please ask a member of staff for advice.

How to contact us:

0117 4145213

www.nbt.nhs.uk

© North Bristol NHS Trust. This edition published May 2018. Review due May 2020. NBT003143

Mycophenolate and pregnancy: Information for men and women