THIS MEDICATION CAN CAUSE HARM TO YOUR BABY
What is teriflunomide?
Teriflunomide (Aubagio) is a pyrimidine synthesis inhibitor that decreases inflammation chemicals that cause multiple sclerosis. It is related to the medication leflunomide (Arava) which is used to treat rheumatoid and psoriatic arthritis.
What is teriflunomide used to treat?
Teriflunomide is an anti-inflammatory medication used to treat relapsing forms of multiple sclerosis.
How does teriflunomide work?
Teriflunomide keeps the body from making as many inflammatory chemicals including lymphocytes.
If I am taking teriflunomide, can it harm my baby?
Teriflunomide is not recommended in pregnancy. Animal studies link the medication to major birth defects including defects of the skull, face, and skeleton. Doses in animal studies were lower than the maximum doses of the medication used in humans. Studies of teriflunomide use in humans are limited. Seventy reports in pregnant women found that, of the women who chose to continue their pregnancies and did not have a miscarriage, all delivered infants who were healthy with no birth defects. All of these women underwent the accelerated elimination procedure.
If I am taking teriflunomide and become pregnant, what should I do?
Before taking teriflunomide, women of childbearing age must exclude the potential for pregnancy, be counseled on the medication’s risks to a developing baby, and use reliable birth control. If you become pregnant while taking this medication, the medication should be discontinued and an accelerated elimination procedure started. This procedure uses agents such as cholestyramine or activated charcoal to remove the drug from the body. These agents are administered for at least 11 days. If you are pregnant and are exposed to teriflunomide, there is a teriflunomide registry that you can join to report your pregnancy outcome.
If I am taking teriflunomide, can I safely breastfeed my baby?
It is unknown whether or not teriflunomide is excreted into the breast milk. If you are on this medication while breastfeeding, it is important to talk to your doctor to weigh the risks versus benefits of taking this medication and/or breastfeeding your baby. Some resources recommend avoiding the medication while breastfeeding due to limited safety information in breastfeeding women.
If I am taking teriflunomide, will it be more difficult to get pregnant?
It is unknown if teriflunomide makes getting pregnant more difficult. Teriflunomide has been detected in male semen. Animal studies found decreased sperm counts in male animals who received the medication. If you want to become pregnant, it is important to discontinue the medication and start the accelerated elimination procedure. You should remain on a reliable birth control method until serum concentrations of the drug reach acceptable blood levels (typically requires 11 days). Without accelerated elimination, the medication can remain detectable in the blood serum for up to 2 years.
If I am taking teriflunomide, what should I know?
If you or your partner are on teriflunomide, birth control should be used. Use of the medication is not recommended during pregnancy because of reports of birth defects in animal babies. If you want to become pregnant or you do become pregnant while on this medication, speak with your doctor immediately. Teriflunomide should be discontinued and an accelerated elimination procedure started to reduce the concentration of the medication in your blood serum.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of anti-inflammatory medication during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert reports about multiple sclerosis here and reports about the individual medications used to treat neurological disorders here. Additional information can also be found in the resources below.
For more information about teriflunomide during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
Sanofi: Aubagio 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.