Bonviva Use In Pregnancy & Lactation

ibandronic acid




Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Bonviva should not be used during pregnancy.
There was no evidence for a direct fetal toxic or teratogenic effect of ibandronic acid in daily orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome). Specific studies for the monthly regimen have not been performed.
There is no clinical experience with Bonviva in pregnant women.
Nursing Mothers: Bonviva should not be used during lactation.
In lactating rats treated with 0.08 mg/kg/day i.v. ibandronic acid, the highest concentration of ibandronic acid in breast milk was 8.1 ng/ml and was seen in the first 2 hours after i.v. administration. After 24 hours, the concentration in milk and plasma was similar, and corresponded to about 5 % of the concentration measured after 2 hours.
It is not known whether Bonviva is excreted in human milk.
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