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Gadobutrol Pregnancy and Breastfeeding Warnings

Gadobutrol is also known as: Gadavist

Gadobutrol Pregnancy Warnings

Animal studies have shown evidence of embryolethality. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category B3 US FDA pregnancy category C

Gadobutrol Breastfeeding Warnings

US: Safety has not been established. May consider interrupting breastfeeding and pumping and discarding breast milk up to 18 hours post-drug administration to minimize exposure to infant. UK: May consider continuing or discontinuing breastfeeding for 24 hours after administration of the drug. AU: At clinical doses, no effects on the infant are anticipated and this drug can be used during breastfeeding. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

Reports on the use of other gadolinium-based contrast agents have shown 0.01% to 0.04% of the maternal gadolinium dose is present in breast milk with limited gastrointestinal absorption in the infant. In lactating rats receiving 0.5 mmol/kg of IV [153Gd]-gadobutrol, 0.01% of the total administered radioactivity was transferred to the offspring via milk within 3 hours after administration.

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