Advagraf Use In Pregnancy & Lactation

Pregnancy: Human data show that tacrolimus crosses the placenta and infants exposed to tacrolimus in utero may be at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and foetal distress.
The use of tacrolimus during pregnancy has been associated with preterm delivery, neonatal hyperkalaemia and renal dysfunction.
Tacrolimus may increase hyperglycaemia 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.
Tacrolimus treatment can be considered in pregnant women, when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus.
In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Lactation: Human data demonstrate that tacrolimus is excreted in breast milk. The effects of tacrolimus on the breastfed 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.
Fertility: A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).