Tocilizumab

Date: May 2020, Version 1

What is it?

Tocilizumab is a type of medicine called a monoclonal antibody. It is used to treat rheumatoid arthritis. Tocilizumab is also being used in clinical trials to see if it can be used to treat coronavirus (COVID-19).

Is it safe to use tocilizumab in pregnancy?

When deciding whether to use tocilizumab during pregnancy it is important to weigh up the potential benefits to your health and wellbeing against any possible risks to you or your baby, some of which may depend on how many weeks pregnant you are. Your doctor or specialist will be able to help you make decisions about your treatment.

What if I have already used tocilizumab during pregnancy?

If you are taking any medicines while pregnant, you can discuss this with your doctor. You can then decide together whether ongoing treatment is appropriate, and if so, your doctor will ensure that you are taking the most effective dose.

Can using tocilizumab in pregnancy cause birth defects in the baby?

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 concerns that tocilizumab causes birth defects. However, data is limited to approximately 350 pregnancies. Further data collection is required to support this finding.

Can using tocilizumab in pregnancy cause miscarriage?

There is no evidence that tocilizumab use in pregnancy is linked to miscarriage. However, the evidence is limited to a relatively small number of pregnancies.

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

The majority of tocilizumab-exposed babies were born at full-term and with normal birth weights. There is not enough evidence to say whether tocilizumab is linked to stillbirth, preterm birth, or low birth weight in the baby. Although there are some case reports of babies being born earlier and with low birth weights, the illnesses in the mothers that tocilizumab was being used to treat are likely to have contributed to these findings.

Will my baby need extra monitoring?

As part of routine antenatal care, most women will be offered a scan at around 20 weeks of pregnancy to look for any problems with the baby. Women who have used tocilizumab may be offered more detailed scans by their doctor. Extra growth scans may be needed due to the underlying conditions that tocilizumab is used to treat.

Are there any risks to the baby after delivery?

Tocilizumab works by changing the immune system. We do not know the effect of this in the newborn baby. As a precaution it is advised that the baby does not receive live vaccines for 6 months following birth. Most vaccines are not live and can therefore be given as normal, however vaccinations against tuberculosis and rotavirus should be delayed. Provided you are not in a high-risk group for tuberculosis, missing these vaccines will not put your baby at any particular risk. After 6 months your baby can have all vaccines as normal.

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

There is currently no evidence that tocilizumab used by the father can harm the baby through effects on the sperm, and most experts agree that this is unlikely.

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 (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.