Obecabtagene autoleucel Pregnancy and Breastfeeding Warnings

Brand names: Aucatzyl

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Obecabtagene autoleucel Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned

There is limited data with use of this drug in pregnant women, however, based on the mechanism of action, it is not recommended for use during pregnancy.

Comments:
- Based on this drug's mechanism of action, if the transduced cells cross the placenta, there may be fetal toxicity, including B-cell lymphocytopenia and hypogammaglobinemia.
- The pregnancy status of females with reproductive potential should be verified and a negative test should be obtained prior to initiating therapy with this drug.

Animal studies have not been reported. There are no controlled data in human pregnancy; however, in one study, a patient became pregnant 6 months following the use of this drug. The patient had a premature delivery at 30 weeks of 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

Obecabtagene autoleucel Breastfeeding Warnings

Safety has not been established.

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

Comments:
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from this or from the underlying maternal condition.

See references

Further information

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