Gadopiclenol Pregnancy and Breastfeeding Warnings

Brand names: Elucirem, Vueway

Gadopiclenol Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: Not assigned

Risk summary:
No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Gadolinium-based contrast agents (GBCAs) have the potential to pass through the human placenta, leading to exposure and retention of this drug in the fetus.
-Currently, the available data on the exposure of GBCAs during pregnancy and their association with adverse fetal outcomes in humans are limited and inconclusive.
-During organogenesis, the intravenous administration of this drug did not result in any harmful developmental effects in rats or rabbits, as shown by animal reproduction studies.

Clinical studies:
-Following the administration of GBCAs to pregnant women, there is an observed visualization enhancement of contrast in the fetal tissues and placenta.
-Studies that have been conducted on cohorts and case reports about exposure to GBCAs during pregnancy have not shown a clear correlation between GBCAs and negative outcomes in the neonates that were exposed.
-A retrospective cohort study that compared pregnant women who received an MRI with GBCA to those who did not receive an MRI reported a higher occurrence of stillbirths and neonatal deaths in the group that received the GBCA MRI. This study's limitations include the lack of a comparison to non-contrast MRI and the absence of information about the maternal indication for MRI.
-Overall, the available data do not allow for a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs during pregnancy.

Preclinical studies:
-GBCAs given to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) and pregnant mice (2 mmol/kg daily on gestational days 16 through 19) led to detectable gadolinium concentrations in the offspring's bone, brain, skin, liver, kidney, spleen, blood, and muscle. These concentrations remain detectable for at least 7 months in non-human primates and at one-month postnatal age in mice.
-This drug was found to cause maternal toxicity in rats at 10 mmol/kg and rabbits at 5 mmol/kg (52 and 57 times the recommended human dose, respectively), characterized by swelling, decreased activity, and lower gestation weight gain and food consumption. However, no adverse effect on embryo-fetal development was observed in rats at 10 mmol/kg, while in rabbits, a lower mean fetal body weight was observed at 5 mmol/kg, which was linked to lower gestation weight gain.

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.

See references

Gadopiclenol Breastfeeding Warnings

Use is not recommended, and a decision should be made to discontinue breastfeeding or the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-The effects on the nursing infant or on milk production are unknown.
-According to published lactation data on other gadolinium-based contrast agents (GBCAs), it has been found that between 0.01% to 0.04% of the gadolinium dose taken by the mother is excreted in breast milk.
-The presence of this drug has been detected in the milk of lactating rats, indicating the possibility of its presence in human milk.

Lactating rats that received a single intravenous injection of this drug showed that 0.3% and 0.2% of the total administered radioactivity was passed on to their offspring through maternal milk, 6 and 24 hours after administration, respectively. Additionally, oral absorption of this drug in nursing rat pups was found to be 3.6%.

See references

Further information

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