Lifileucel Pregnancy and Breastfeeding Warnings

Brand names: Amtagvi

Medically reviewed by Drugs.com. Last updated on Apr 9, 2024.

Lifileucel Pregnancy Warnings

Use is not recommended; safety has not been established.

US FDA pregnancy category: Not assigned

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

Comments:
-Verify the pregnancy status of sexually active females of reproductive potential prior to therapy initiation.
-Pregnancy (or planning a pregnancy) after treatment should be discussed with the prescribing health care provider.
-A pregnancy exposure registry is available.

Animal studies have not been conducted with this drug. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, pregnancies should be reported to Iovance Biotherapeutics, Inc by calling 1-833-400-IOVA.

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

Lifileucel Breastfeeding Warnings

Safety has not been established.

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

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

See references

Further information

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

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