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Omidubicel Pregnancy and Breastfeeding Warnings

Brand names: Omisirge

Medically reviewed by Drugs.com. Last updated on Feb 13, 2024.

Omidubicel Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not Assigned

Risk Summary: There is no data on use in pregnant women to know this product's risks, including the risk of fetal harm or reproductive effects.

Comments:
-This product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
-Pregnancy status of female patients with reproductive potential should be verified prior to starting the conditioning regimen for infusion.
-There are insufficient data to provide a recommendation about contraception following treatment. See the prescribing information for the medications used during the conditioning for information on the need for effective contraception in patients receiving the conditioning regimen.
-There are no data on the effect on fertility.

Animal studies are not available for this product. 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 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

Omidubicel Breastfeeding Warnings

Safety has not been established.

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

Comments:
-There is no information regarding this product on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this treatment as well as any potential adverse effects from this product or the underlying maternal condition.

See references

See also

References for pregnancy information

  1. (2023) "Product Information. Omisirge (omidubicel)." Gamida Cell Inc.,

References for breastfeeding information

  1. (2023) "Product Information. Omisirge (omidubicel)." Gamida Cell Inc.,

Further information

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

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