Prograf Use In Pregnancy & Lactation

Pregnancy: Category C.
Tacrolimus is transferred across the placenta and infants exposed to tacrolimus in utero may be at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress. The use of tacrolimus during pregnancy has been associated with preterm delivery, neonatal hyperkalemia and renal dysfunction. Tacrolimus may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). Monitor maternal blood glucose levels regularly. Tacrolimus may exacerbate hypertension in pregnant women and increase pre-eclampsia. Monitor and control blood pressure. Females and males of reproductive potential should consider the use of appropriate contraception prior to starting treatment with tacrolimus.
Prograf should be used during pregnancy only if the potential benefit to the mother justifies potential risk to the fetus.
In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity.
Nursing Mothers: Tacrolimus is excreted in human milk. The effects of tacrolimus on the breast-fed infant, or on milk production have not been assessed. As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving tacrolimus.