Tacrolimus

(Date: September 2021. Version: 3)

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?

Tacrolimus 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 available as an ointment that is applied to the skin to treat eczema and psoriasis. Brand names include: Envarsus, Adoport, Prograf, Advagraf, Dailiport, Modigraf, and Protopic,

What are the benefits of using tacrolimus in pregnancy?

Tacrolimus helps to stop your body rejecting a transplanted organ. When used in ointment form, it can improve symptoms in women with eczema and psoriasis.

What are the risks of using tacrolimus in pregnancy?

There are no known risks of using tacrolimus ointment in pregnancy.

Only a small number of pregnant women taking tacrolimus tablets have been studied but the available information does not raise concern that its use causes problems. Ongoing research is ideally required.

Are there any alternatives to using tacrolimus in pregnancy?

Yes, other medicines can also be used in pregnancy to prevent rejection of a transplanted organ or to treat eczema and psoriasis, but if tacrolimus was working well before pregnancy, a woman may be advised by her doctor to continue taking it.

Women who accidentally conceive while taking tacrolimus should arrange to see their doctor or specialist to ensure that tacrolimus is still the best treatment and to make sure the dose is correct.

What if I prefer not to take tacrolimus during pregnancy?

To stop organ rejection after a transplant it is very important to continue taking tacrolimus or a similar immunosuppressant. Some women with severe skin conditions may also need to continue treatment during pregnancy. Your doctor will only prescribe medicines when absolutely necessary and will be happy to talk to you about any concerns that you might have.

Please do not stop tacrolimus without speaking to your midwife, GP or specialist.

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. No additional monitoring is required due to taking tacrolimus in pregnancy, although transplant recipients are likely to be offered additional blood tests and monitoring of the baby’s wellbeing.

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

There is currently no evidence that tacrolimus 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 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.

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

Our online reporting system offers all pregnant women, and women who have been pregnant in the past, the opportunity to create their own digitally secure ‘my bumps record’. You will be asked to enter information about your health, whether or not you take any medicines, and your pregnancy outcome. 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 https://www.medicinesinpregnancy.org/Login/ to register.

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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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