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Teriflunomide Pregnancy and Breastfeeding Warnings

Teriflunomide is also known as: Aubagio

Medically reviewed by Last updated on Jul 15, 2019.

Teriflunomide Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: X

-Use of adequate methods of contraception by both females and males is recommended during and for 2 years after stopping treatment.

Animal studies have shown reproductive toxicity, embryolethality and teratogenicity. There are no controlled data in human pregnancy.

This drug has been detected in human semen. Men wanting to father a child should discontinue use and perform an accelerated elimination procedure to decrease the plasma concentration of teriflunomide to less than 0.02 mg/L.

Women of childbearing potential should use effective contraception during treatment and after treatment as long as teriflunomide plasma concentration is above 0.02 mg/L. Patients should be advised if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify a physician immediately for pregnancy testing. If pregnancy is confirmed, the patient should be advised of the risk to the fetus. There is a possibility that rapidly lowering the blood level of teriflunomide, at the first delay of menses, may decrease the risk to the fetus. For women receiving teriflunomide treatment, who wish to become pregnant, the drug should be stopped and an accelerated elimination procedure is recommended in order to more rapidly reach a concentration below 0.02 mg/L. See Warnings section for further information on accelerated elimination.

A teriflunomide pregnancy registry has been established. Healthcare providers are encouraged to enroll the patient in this registry if pregnancy occurs during treatment.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Teriflunomide Breastfeeding Warnings

Animal studies have revealed that teriflunomide passes into milk and can cause harm to the developing neonate at subclinical maternal exposures.

Use is contraindicated. (UK)
A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. (AU, US)

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Aubagio (teriflunomide)." Genzyme Corporation, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Aubagio (teriflunomide)." Genzyme Corporation, Cambridge, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.