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Tofacitinib Pregnancy and Breastfeeding Warnings

Tofacitinib is also known as: Xeljanz

Tofacitinib Pregnancy Warnings

At high doses, tofacitinib has been shown to be fetocidal and teratogenic in rats and rabbits. There are no controlled data on use in pregnant women. Pregnancy Registry: To monitor outcomes of pregnant women exposed to tofacitinib, a US pregnancy registry has been established. Physicians and pregnant women can register by calling 1-877-311-8972. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use only if the potential benefit outweighs the potential risk to the fetus. US FDA pregnancy category: C

Tofacitinib 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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