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Women of child-bearing potential: Women of child-bearing potential should be advised to avoid becoming pregnant and advised of the potential hazard to the fetus while receiving Zoledronic acid. There may be a risk of fetal harm (e.g. skeletal and other abnormalities) if a woman becomes pregnant (see Contraindications) while receiving bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration on this risk has not been established.
Pregnancy: Studies in rats have shown reproductive toxicological effects (see Pharmacology: Toxicology: Non-Clinical Safety Data under Actions). The potential risk in humans is unknown. Zoledronic acid should not be used during pregnancy (see Contraindications).
Breast-feeding: It is not known whether zoledronic acid is excreted into human milk. Zoledronic acid should not be used by breast-feeding women (see Contraindications).
Fertility: The fertility was decreased in rats dosed subcutaneously with 0.01 mg/kg/day of zoledronic acid with systemic exposures of 0.12 times the human systemic exposure following an intravenous dose of 4 mg (based on AUC). The effects observed included an increase in pre-implantation losses and a decrease in the number of implantations and live fetuses. There are no data available in humans.
