Remicade

THE SAFTEY OF INFLIXIMAB (REMICADE) 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 is considered to have a low risk when used during pregnancy.  It should not be used with methotrexate.

What is Infliximab?

Infliximab stops chronic inflammation in the body that causes autoimmune diseases such as rheumatoid arthritis.

What is Infliximab used to treat?

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

How does infliximab work?

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

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

The World Congress of Gastroenterology finds that infliximab is associated with low risk to the developing baby when used during conception in men or during the first 2 trimesters of pregnancy in women. Infliximab does cross the human placenta after the first trimester, but no studies have identified adverse effects associated with maternal use during pregnancy. Some studies have suggested that infliximab is associated with an increased risk of prematurity and low birth weight, but no correlation has been proven. The effect of infliximab on long-term infant immune function is unknown. There is a study that collects data from pregnancies exposed to infliximab: MotherToBaby Autoimmune Diseases Study. Your doctor can enroll you in this study if you take infliximab during pregnancy.

Infliximab should only be used for treatment in pregnant women who need the medication. It is recommended to limit the use of infliximab to the first 30 days of pregnancy. Infants exposed to infliximab in the womb may require a 6 month waiting period before administration of live vaccines. For women who are also taking methotrexate, it is important to speak with your doctor to decide if you should continue taking the medication.

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

The World Congress of Gastroenterology has stated that infliximab is safe during breastfeeding; however, the medication’s packaging states that it should not be used by breastfeeding women. It is important to talk to your doctor to decide if you should continue on infliximab during breastfeeding.

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

The World Congress of Gastroenterology has stated that infliximab can be used in men or women during conception. It is unknown if it affects reproduction in humans; available recommendations are based on animal studies of a similar antibody. A small sample of men exposed to infliximab found no consistent negative effect on male sperm.

If I am taking infliximab, what should I know?

Although infliximab may be associated with a small risk of side effects in the developing 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 Remicade 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 psoriasis here. Additional information can also be found in the resources below. 

For more information about infliximab during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Janssen: Remicade 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.