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There no adequate and well-controlled studies of topically administered tacrolimus in pregnant women. The experience with tacrolimus ointment when used by pregnant women is limited.
Tacrolimus is transferred across the placenta. It is secreted also in milk.
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is minimal relative to systemic administration, tacrolimus ointment should be used during pregnancy and in nursing mothers only if the potential benefit to the mother justifies a potential risk to the fetus.
