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Pregnancy: Category: D.
There are no adequate data on the use of zoledronic acid in pregnant women. Animal reproduction studies with zoledronic acid have shown reproductive toxicity. The potential risk for humans is unknown. Zoledronic acid Fresenius Kabi should not be used during pregnancy.
Breast-feeding: It is not known whether zoledronic acid is excreted into human milk. Zoledronic acid Fresenius Kabi is contraindicated in breads-feeding women (see Contraindications).
Fertility: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1generation. This resulted in exaggerated pharmacological effects considered to be related to the compound’s inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study. Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
