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Axicabtagene ciloleucel Pregnancy and Breastfeeding Warnings

Axicabtagene ciloleucel is also known as: Yescarta

Medically reviewed on November 6, 2017

Axicabtagene ciloleucel Pregnancy Warnings

No animal reproductive and developmental toxicity studies have been conducted with this drug to assess whether it can cause fetal harm when administered to a pregnant woman. It is unknown if this drug has the potential to be transferred to the fetus. There are no controlled data in human pregnancy, and no data on the effect of this drug on fertility.

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 is not recommended during pregnancy, and pregnancy after infusion of this drug should be discussed with the treating physician.

US FDA pregnancy category: Not Assigned

Comments:
-Based on its mechanism of action, this drug may cause fetal toxicity (including B-cell lymphocytopenia) if the transduced cells cross the placenta.
-Direct females of reproductive potential to have a pregnancy test prior to starting treatment with this drug.
-There is insufficient data to provide a recommendation concerning duration of contraception following treatment with this drug.
-Consult the manufacturer product information for fludarabine and cyclophosphamide regarding the need for effective contraception in patients who receive the lymphodepleting chemotherapy.

See references

Axicabtagene ciloleucel Breastfeeding Warnings

Safety has not been established.

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

Comments:
-The effects in the nursing infant and on milk production are unknown.
-When weighing the benefits and risks, consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Yescarta (axicabtagene ciloleucel)." Kite Pharma, Inc., El Segundo, CA.

References for breastfeeding information

  1. "Product Information. Yescarta (axicabtagene ciloleucel)." Kite Pharma, Inc., El Segundo, CA.

Further information

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

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