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Fingolimod Pregnancy and Breastfeeding Warnings

Fingolimod is also known as: Gilenya

Fingolimod Pregnancy Warnings

Fingolimod has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of fetal harm, including teratogenicity and embryolethality. There are no controlled data in human pregnancy. The manufacturer recommends that fingolimod should only be used during pregnancy when the potential benefits outweigh the potential risks to the developing fetus. In order to avoid potential fetal harm, women of childbearing potential should avoid pregnancy during and for 2 months after discontinuation of fingolimod.

Developmental toxicity, including teratogenicity and embryolethality has been reported in rats and rabbits following oral administration of fingolimod during organogenesis. In rats, the most frequently reported fetal visceral malformations were persistent truncus arteriosus and ventricular septal defect. Fingolimod affects the receptor (sphingosine 1-phosphate) which is involved in vascular formation during embryogenesis. Additionally, following oral administration of fingolimod in rats during pregnancy and lactation, pup survival was reduced and a neurobehavioral deficit was reported in the offspring. The effects of fingolimod during labor and delivery are unknown. To monitor maternal-fetal outcomes of pregnant women exposed to fingolimod therapy, a pregnancy registry has been established. Physicians are encouraged to prospectively register pregnant patients, or pregnant women may register themselves by calling: 1-877-598-7237.

Fingolimod Breastfeeding Warnings

There are no data on the excretion of fingolimod into human breast milk; however, it is excreted into the milk of lactating rats. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the benefit of breast-feeding to the infant and the importance of the drug to the mother.

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