Aclasta Use In Pregnancy & Lactation

Pregnancy: Risk Summary: Aclasta is contraindicated during pregnancy (see CONTRAINDICATIONS). Studies in rats have shown reproductive toxicological effects. The potential risk in humans is unknown.
There is a theoretical risk of fetal harm (e.g skeletal, and other abnormalities) if a woman becomes pregnant 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 have not been established (See CONTRAINDICATIONS and Pharmacology: Toxicology: NON-CLINICAL SAFETY DATA under Actions).
Data: Human data: There are no data on the use zoledronic acid in pregnant woman.
Animal Data: Teratogenicity studies were performed in two species, both via subcutaneous administration of zoledronic acid. In rats, teratogenicity was observed at dose ≥ 0.2 mg/kg/day (2.4 fold, the anticipated human exposure, based on AUC comparison) and was manifested by external, visceral and skeletal malformations. Dystocia was observed at the lowest dose (0.01 mg/kg/day) tested in rat.
In rabbits, no teratogenic or embryo/fetal effects were observed, although maternal toxicity was marked at 0.1 mg/kg/day. Adverse maternal effects were associated with, and may have been caused by, drug-induced hypocalcemia.
Lactation: Risk Summary: Aclasta is contraindicated in breast-feeding women (see CONTRAINDICATIONS).
Females and males of reproductive potential: Women of child-bearing potential should be advised to avoid becoming pregnant while receiving Aclasta.
Infertility: The fertility was decreased in rats dosed subcutaneously with 0.1 mg/kg/day of zoledronic acid. There are no data available in humans.