Everolimus

(Date: September 2021. Version: 2)

This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by Public Health England on behalf of UK Health Departments. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy.

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.

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.

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General information 

Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. These are referred to as the background population risks.  They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account.

Medicines use in pregnancy

Most medicines used by the mother will cross the placenta and reach the baby. Sometimes this may have beneficial effects for the baby.  There are, however, some medicines that can harm a baby’s normal development.  How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant.

If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy.

When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby.   

Every pregnancy is unique. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider. It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records.

   

www.medicinesinpregnancy.org

Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. New information is continually becoming available. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date.

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