Fingolimod

Date: July 2021, Version 1

What is it?

Fingolimod is a medicine used to treat the relapsing-remitting form of multiple sclerosis (MS).

Benefits

What are the advantages of using fingolimod in pregnancy?

Fingolimod reduces MS symptoms by stopping the immune system from attacking the nervous system.

Risks

Are there any risks of using fingolimod in pregnancy?

When fingolimod was first available and used during pregnancy, there were early reports of babies being born with birth defects. It is still unclear whether these birth defects were caused by the medication or not. More recent studies raise further concerns, although it is still not possible to be certain as the studies were small in size. For this reason, fingolimod is not generally recommended for use during pregnancy.

Alternatives

Are there any alternatives to using fingolimod in pregnancy?

Yes. Other medicines can be used to treat MS during pregnancy, although for some women these may not work as well as fingolimod.

You may find that your symptoms improve during pregnancy; if so, your specialist may advise that your medicine(s) can be altered or stopped. However, please do not change or stop your medication without speaking to your doctor.

If you are planning a pregnancy you should speak to your specialist to determine which medicine is best. This can be arranged through your GP or neurology clinic nurse.

If you become pregnant while taking fingolimod then you should be reviewed by your doctor as soon as possible.

No treatment

What if I prefer not to use medicines to treat MS in pregnancy?

Your doctor will be happy to talk to you about any concerns that you might have. It is important that your MS is well treated during pregnancy in order to to avoid a flare-up of symptoms and to keep you healthy.

Will I or my baby need any extra monitoring?

All women in the UK are offered a detailed anomaly scan at around 20 weeks of pregnancy as part of routine antenatal care. No additional monitoring is required if you are using fingolimod in pregnancy, although you may be offered extra growth scans.

Are there any risks to my baby if the father takes fingolimod?

We would not expect any increased risk to your baby if the father takes fingolimod.

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.