Everolimus

(Date of issue: March 2017. Version: 1)

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 a medicine that is most commonly used to prevent organ rejection in people who have had a kidney or heart transplant. It is also used to treat certain types of breast, pancreatic, gastrointestinal, lung, and kidney cancer. Use in patients with a genetic condition called tuberous sclerosis is also increasing. Everolimus works in a similar way to another medicine called sirolimus.

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.

Is it safe to take everolimus in pregnancy?

Very little is known about the use of everolimus in pregnancy. At present, there is only information on six babies of women who were treated with everolimus throughout their pregnancy (see below). This is why use of everolimus in pregnancy is also not recommended

Any woman taking everolimus who could become pregnant is therefore advised to use a reliable form of contraception. If you are taking everolimus and are considering a pregnancy it is important to discuss your treatment options with your doctor before attempting to conceive. It may be possible, depending on your illness, to change to another medicine that has been used without evidence of harm in a larger number of pregnancies. Where pregnancy has already occurred, for some women continued treatment with everolimus may be considered the only suitable treatment option. The risks to the baby in this situation will be largely unknown.

This leaflet summarises the available information relating to the effects of everolimus on a baby in the womb. It is important to consider this information if you are being treated with everolimus and are pregnant or considering a pregnancy.

Can taking everolimus in early pregnancy cause my baby to be born with birth defects?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

There are currently no large scientific studies that have investigated whether everolimus use during the first trimester of pregnancy can cause birth defects in the baby. We have only been able to identify case studies of six babies who were born to pregnant women who took everolimus in the first trimester. None of these babies were born with birth defects, however information on many more pregnancies needs to be collected before it is possible to accurately assess whether everolimus causes birth defects.

Can taking everolimus in pregnancy cause miscarriage, stillbirth, preterm birth, or my baby to be small at birth (low birth weight)?

No studies have specifically analysed whether these outcomes are more or less common in pregnant women taking everolimus.

Can taking everolimus in pregnancy cause learning and behavioural problems in the child?

A baby’s brain continues to develop right up until the end of pregnancy. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

No studies have been carried out to investigate whether everolimus exposure in the womb might affect a child’s learning and behaviour. Nearly all medicines still need to be studied to determine whether exposure in the womb might affect a child’s learning or behaviour.

What if I have already taken everolimus during pregnancy?

There is currently too little information on the use of Everolimus in pregnancy to assess how it may affect a developing baby in the womb. It is therefore important to let your doctor know as soon as possible that you are pregnant so that any additional monitoring of you and your pregnancy can be arranged if needed.

If you are taking any medicines it is always a good idea to let your doctor know that you are pregnant so that you can decide together whether you still need the medicines that you are on or whether you might need to switch to a different medicine.

Will I or my baby need extra monitoring during pregnancy?

Most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care.

Because the effects of taking everolimus in early pregnancy are largely unknown your doctor may suggest extra monitoring of your baby, including more detailed or earlier scans to detect birth defects, and more frequent review of your baby’s growth in the womb.

Women who have previously received an organ transplant will also be more closely monitored during pregnancy to ensure that they remain well throughout and that their baby is growing and developing as expected. 

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

There are no scientific reports of babies born to men who were treated with everolimus around the time of conception. Most experts agree that the majority of medicines used by the father are unlikely to harm the baby through effects on the sperm. However, more research on the effects of everolimus specifically and medicine use in men around the time of conception generally is needed.

Who can I talk to if I have questions?

If you have any questions regarding 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.

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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