Animal studies show measurable gadolinium levels in the offspring in bone, brain, skin, liver, blood, kidney, and spleen for at least 7 months (primates; 1 month in mice). Because pregnant animals received repeated daily doses, their exposure was significantly higher than would be expected with the typical single human dose. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use during pregnancy only if imaging is essential and cannot be delayed.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-Gadolinium-based contrast agents (GBCAs) cross the placenta causing fetal exposure and gadolinium retention.
-Human data on GBCAs and adverse fetal events are limited and inconclusive.
-Animal data did not show teratogenicity, but embryolethality was seen in several animal models at intravenous doses 8 times or more the recommended human dose when given during organogenesis.
-Embryonal development delays were seen in animals at intravenous doses 8 and 12 times the recommended human dose.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Other gadolinium-based contrast agents (GBCAs) indicate 0.01 to 0.04% of the gadolinium dose appears in human breast milk, with limited gastrointestinal absorption in the infant.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

Animal studies of 0.5 mmol/kg intravenous [153Gd]-gadobutrol showed 0.01% of the total radioactivity transferred to the pup within 3 hours of the dose; gastrointestinal absorption is poor, with about 5% of the oral dose excreted in the urine.

See references