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Teriflunomide Pregnancy and Breastfeeding Warnings

Teriflunomide is also known as: Aubagio

Teriflunomide Pregnancy Warnings

FDA pregnancy category: X Use of teriflunomide is contraindicated. Comments: Use of adequate methods of contraception by both females and males in encouraged during and for 2 years after stopping treatment.

Animal studies resulted in decreased growth, eye and skin abnormalities, high incidences of fetal malformation, postnatal death, and embryofetal death at doses not associated with maternal toxicity. There are no controlled data in human pregnancy. Teriflunomide has been detected in human semen. A teriflunomide pregnancy registry has been established to monitor fetal outcomes of exposed pregnant women. Healthcare providers are encouraged to enroll pregnant women (pregnant women can enroll themselves) by calling 1-800-745-4447, option 2 (USA). 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.

Teriflunomide Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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