THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
There is limited information available on tocilizumab; the safety of tocilizumab is unknown during pregnancy.
What is tocilizumab?
Tocilizumab is an immunomodulator that is used to treat inflammatory autoimmune disease.
What is tocilizumab used to treat?
Tocilizumab is a prescription medication used to treat moderate to severe rheumatoid arthritis in adults and juvenile idiopathic arthritis in children over 2 years old.
How does tocilizumab work?
Tocilizumab is an antibody that suppresses the production of chemicals in the body that cause inflammation.
If I am taking tocilizumab, can it harm my baby?
Tocilizumab has not been associated with birth defects or spontaneous abortion (miscarriage) in animal or human studies. Tocilizumab may cross the placenta late in gestation (ex. third trimester) to reach the developing baby. Tocilizumab may affect the immune function of the developing baby. Timing of delivery may also be affected by tocilizumab use during pregnancy.
If I am taking tocilizumab and become pregnant, what should I do?
Your doctor may encourage you to participate in a pregnancy registry if you take tocilizumab during pregnancy . Several human studies have evaluated the safety of tocilizumab in women who discontinued the medication around the time of conception. Pregnancies that have tocilizumab exposure during early gestation should be monitored via ultrasound. A study in 288 women exposed to tocilizumab before or during pregnancy found an increased risk of preterm birth with tocilizumab exposure.
If I am taking tocilizumab, can I safely breastfeed my baby?
Your doctor may suggest that you either discontinue tocilizumab or discontinue breastfeeding. Tocilizumab is expected to pass into the breast milk, but information on breastfeeding infants is limited. It is important to weigh the risks versus benefits of tocilizumab treatment during pregnancy and breastfeeding for the infant and mother.
If I am taking tocilizumab, will it be more difficult to get pregnant?
Available information in animal studies has found no effects of tocilizumab on male or female fertility. One study evaluating human males exposed to tocilizumab found no effect on pregnancy outcomes.
If I am taking tocilizumab, what should I know?
It is important to speak with your doctor to determine if you should continue tocilizumab therapy during pregnancy or while breastfeeding. While no birth defects have been associated with the medication, there may be an increased risk of preterm birth or other changes in delivery timing. Exposure to tocilizumab during the third trimester of pregnancy may affect the baby's immune function and requires delayed exposure of infants to live vaccines.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of tocilizumab during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert reports about autoimmune diseases here, reports about the individual medications used to treat immune disorders here, and a report about rheumatoid arthritis here. Additional information can also be found in the resources below.
For more information about tocilizumab during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
Gene.com: Actemra Prescribing Information
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.