Date: September 2021, Version 2

What is it?

Everolimus is known as an immunosuppressant as it dampens the immune response. It is taken in tablet form to prevent organ rejection in people who have received a transplant. It is also used in the treatment of some cancers and to treat tumours caused by a genetic disease called tuberous sclerosis complex.

Very little is known about everolimus use in pregnancy. If you have taken everolimus and would like to register your pregnancy directly with UKTIS please create a ‘bumps pregnancy record’ which you can then update during your pregnancy. The information you provide will be used to help improve treatment and advice for women in the future.

If you are being treated in the UK, your doctor can also report your pregnancy to UKTIS using our reporting form for health care professionals.


What are the benefits of using everolimus in pregnancy?

Everolimus helps to stop your body rejecting a transplanted organ. It can also inhibit tumour growth in people with certain cancers and a genetic disease called tuberous sclerosis complex.


What are the risks of using everolimus in pregnancy?

Only seven pregnant women taking everolimus have been reported in the scientific literature. Even though everolimus use was not linked to any problems in their babies, more information needs to be collected to confirm that everolimus is safe to use in pregnancy.


Are there any alternatives to using everolimus in pregnancy?

Possibly. Other immunosuppressant medicines can be used in pregnancy, so switching to a different drug may be an option. However, if everolimus was working well before pregnancy and there is a chance that other drugs might not be as effective in controlling a woman’s medical condition, she may be advised by her doctor to continue taking it.

Women who accidentally conceive while taking everolimus should arrange to see their doctor or specialist as soon as possible to check whether everolimus is still the best treatment and to make sure the dose is correct.

No treatment

What if I prefer not to take medicines during pregnancy?

It is very important to continue with treatment during pregnancy to reduce the chance of your cancer spreading or your transplanted organ being rejected. Your doctor will only prescribe medicines when necessary and will be happy to talk to you about any concerns that you might have.

Will I or my baby need extra monitoring?

As part of routine antenatal care, most women will be offered a very detailed scan at around 20 weeks of pregnancy to check the baby’s development. Because the effects of everolimus on the developing baby are largely unknown, you may be offered extra monitoring of the baby’s growth and wellbeing.

Are there any risks to my baby if the father has used everolimus?

There is currently no evidence that everolimus used by the father can harm the baby through effects on the sperm

Who can I talk to if I have questions?

If you have any questions about the information in this leaflet please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org.

How can I help to improve drug safety information for pregnant women in the future?

Our online reporting system (MyBump Portal) allows women who are currently pregnant to create a secure record of their pregnancy, collected through a series of questionnaires. You will be asked to enter information about your health, whether or not you take any medicines, your pregnancy outcome and your child's development. You can update your details at any time during pregnancy or afterwards. This information will help us better understand how medicines affect the health of pregnant women and their babies. Please visit the MyBump Portal to register.

General information
Sadly, miscarriage and birth defects can occur in any pregnancy.

Miscarriage occurs in about 1 in every 5 pregnancies, and 1 in every 40 babies are born with a birth defect. This is called the ‘background risk’ and happens whether medication is taken or not.

Most medicines cross the placenta and reach the baby. For many medications this is not a problem. However, some medicines can affect a baby’s growth and development.

If you take regular medication and are planning to conceive, you should discuss whether your medicine is safe to continue with your doctor/health care team before becoming pregnant. If you have an unplanned pregnancy while taking a medicine, you should tell your doctor as soon as possible.

If a new medicine is suggested for you during pregnancy, please make sure that the person prescribing it knows that you are pregnant. If you have any concerns about a medicine, you can check with your doctor, midwife or pharmacist.

Our Bumps information leaflets provide information about the effects of medicines in pregnancy so that you can decide, together with your healthcare provider, what is best for you and your baby.