The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

This medication is considered to have a low risk when used during pregnancy

What is certolizumab pegol?

Certolizumab pegol is a recombinant human antibody that binds to and inactivates immune system substances that cause inflammation.

What is certolizumab pegol used to treat?

Certolizumab pegol is a prescription medication used to treat moderate or severe Crohn’s disease, particularly in patients not responding to conventional therapies. It is also used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

How does certolizumab pegol work?

Certolizumab pegol blocks chemicals released by the immune system that cause inflammation.  It is combined with another substance that slows down its excretion from the body to maximize its effectiveness.

If I am taking certolizumab pegol, can it harm my baby?

Certolizumab pegol does cross the placenta during late pregnancy, but the dose reaching the developing baby is only a small fraction of the mother’s dose. One study in 13 women exposed to certolizumab pegol during pregnancy found placental transfer to the baby was undetectable. When certolizumab pegol is used with steroids, there maybe an increased risk of maternal infection and preterm delivery.

Animal studies using a rodent compound similar to certolizumab pegol found that a dose ten times that of a human dose did not cause harm to the baby, impaired fertility, or other adverse effects. In a group of women exposed to certolizumab pegol primarily during the first trimester of pregnancy, 75% had successful live births. Reports of birth defect rates in babies exposed to certolizumab pegol are similar to birth defect rates in the general U.S. population. There are also dangers to the baby such as preterm delivery and low birthweight associated with active, untreated autoimmune conditions such as rheumatoid arthritis.

In a European study comparing pregnant women taking medications such as certolizumab pegol compared to women not exposed to these medications, there was a higher cumulative risk of birth defects. But, the study had some noted design flaws and a lack of statistical certainty to support this conclusion. A large analysis of multiple studies found no increase in birth defects with the class of medications that includes certolizumab pegol.

If I am taking certolizumab pegol and become pregnant, what should I do?

Certolizumab pegol can be continued during pregnancy if required since it’s considered a low risk medication. If certolizumab pegol is continued during pregnancy, it may be advisable to stop the medication at 30 weeks gestation. It is important to speak with your doctor to determine the best course of action if you are on this medication and become pregnant. Your doctor should inquire about your participation in the certolizumab pegol pregnancy registry or ongoing manufacturer studies.

If I am taking certolizumab pegol, can I safely breastfeed my baby?

Although the manufacturer of certolizumab pegol recommends discontinuing breastfeeding during therapy, some experts believe breastfeeding should be safe to continue during therapy. It is important to weigh the risks versus benefits of discontinuing the medication versus discontinuing breastfeeding.  In one case study, undetectable amounts of certolizumab pegol were found in breast milk samples from a mom who was breastfeeding while on the medication. Infant absorption of the medication is minimal since it is more than likely destroyed in the infant’s stomach.

A study in 17 breastfeeding women taking certolizumab pegol found that 56% of breast milk samples had undetectable amounts of the medication. The detectable traces of the medication in breast milk samples were considered trace amounts. Additional studies in breastfeeding women found no medication related complications in the infant after 1 year of monitoring as long as certolizumab pegol was taken alone. Combination of certolizumab pegol with other immune suppressing medications was associated with an increase in infant infections in one study.

If I am taking certolizumab pegol, will it be more difficult to get pregnant?

There is no evidence that this medication negatively impacts fertility.

If I am taking certolizumab pegol, what should I know?

Although there is limited data in humans, certolizumab pegol is generally considered safe and low risk during conception and pregnancy. Talk to your doctor about the pros and cons of using this medication during pregnancy.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of certolizumab pegol during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about immune disorders here and reports about the individual medications used to treat immune disorders here.   Additional information can also be found in the resources below. 

For more information about certolizumab pegol during and after pregnancy, contact (800-994-9662 [TDD: 888-220-5446]) or check the following link: Cimzia Prescribing Information

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General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.