Humira

THE SAFETY OF ADALIMUMAB (HUMIRA) DURING PREGNANCY OR BREASTFEEDING

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 CAN CAUSE HARM TO YOUR BABY:

Adalimumab has a low risk with use during pregnancy, but it is important to speak with your doctor if you are on this medication and become pregnant.

What is adalimumab?

Adalimumab stops chronic inflammation in the body that causes autoimmune diseases such as rheumatoid arthritis. It is part of a class of drugs known as tumor necrosis factor inhibitors.

What is adalimumab used to treat?

Adalimumab is a prescription medication used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, juvenile idiopathic arthritis, ankylosing spondylitis, and psoriasis.

How does adalimumab work?

Adalimumab is an antibody that blocks the production of certain inflammatory chemicals in the body that cause autoimmune disease.

If I am taking adalimumab, can it harm my baby?

The World Congress of Gastroenterology finds that adalimumab is associated with low risk to the developing baby when used during conception or during the first 2 trimesters of pregnancy. Adalimumab does cross the human placenta to reach the baby after the first trimester, but studies have not identified an increased risk of adverse effects such as birth defects or spontaneous abortion (miscarriage) with use during pregnancy. Some studies have suggested that adalimumab is associated with an increased risk of prematurity and low birth weight, but no correlation has been proven. The effect of adalimumab on long-term infant immune function is unknown. There is an ongoing study that collects data from pregnancies exposed to adalimumab: OTIS Autoimmune Disease Study.

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

Adalimumab should only be used for treatment in pregnant women who need the medication. It is recommended to limit the use of adalimumab to the first 30 days of pregnancy. Infants exposed to adalimumab in the womb may require a waiting period before administration of live vaccines.

If I am taking adalimumab, can I safely breastfeed my baby?

Adalimumab is expected to be transferred in small quantities through breast milk, but not much is absorbed by a breastfeeding infant. The exact concentration of infant adalimumab exposure through breast milk is 0.1% to 1% of the maternal dose. No major adverse events have been reported with adalimumab use while breastfeeding, but it is important to talk to your doctor to decide if you should continue on adalimumab while breastfeeding. The risks and benefits to the mother and baby should be considered before making any decisions on continuation or discontinuation of adalimumab or breastfeeding.

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

The World Congress of Gastroenterology has stated that adalimumab can be used in men or women during conception. Studies have not found any consistent impact of adalimumab therapy on male or female fertility.

If I am taking adalimumab, what should I know?

Although adalimumab may be associated with a small risk of side effects in the baby, serious birth defects are not increased with its use during pregnancy.

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

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

You may find Pregistry's expert report about rheumatoid arthritis here, reports about other 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 adalimumab during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

RXAbbVie:  Humira Prescribing Information

Read the whole report
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.