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Xenon xe 129 hyperpolarized Pregnancy and Breastfeeding Warnings

Brand names: Xenoview

Xenon xe 129 hyperpolarized Pregnancy Warnings

Safety has not been established during pregnancy.

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.

This drug is minimally absorbed systemically following the inhalation route of administration, and maternal use is not expected to result in fetal exposure to the drug.

Various animal studies conducted in rats have failed to reveal evidence of teratogenicity and showed no effects on fertility or pregnancy. There are no controlled data in human pregnancy.

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 healthcare 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

Xenon xe 129 hyperpolarized Breastfeeding Warnings

Safety has not been established. It is unlikely that an infant will be exposed to this agent through breastfeeding.

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

Comments: All possible adverse effects on the breastfed child as well as the benefits of breastfeeding should be evaluated when considering the use of this agent.

See references

References for pregnancy information

  1. (2022) "Product Information. Xenoview (xenon Xe-129)." Polarean, Inc

References for breastfeeding information

  1. (2022) "Product Information. Xenoview (xenon Xe-129)." Polarean, Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.