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Fertility: There are no fertility data available.
Pregnancy: There are no adequate data from the use of tacrolimus ointment in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). The potential risk for humans is unknown.
PROTOPIC ointment should not be used during pregnancy unless clearly necessary.
Breast-feeding: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk. Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with PROTOPIC ointment is not recommended.
