Lovotibeglogene autotemcel Pregnancy and Breastfeeding Warnings

Brand names: Lyfgenia

Medically reviewed by Drugs.com. Last updated on Jan 30, 2024.

Lovotibeglogene autotemcel Pregnancy Warnings

This drug should not be used 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.

Comments:
-Pregnancy status should be verified before the start of mobilization, conditioning procedures, and before administering this drug.
-Risks associated with myeloablative conditioning agents on pregnancy and fertility should be considered.
-Advise patients of the risks associated with conditioning agents.
-Women of childbearing potential and men capable of fathering a child should use effective method of contraception before mobilization and for 6 months after the last dose.
-Patients should be informed of the risks and the options for fertility preservation.
-Pregnancy following infusion of this drug should be discussed with the treating physician.

Animal studies have not been reported. 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

Lovotibeglogene autotemcel Breastfeeding Warnings

Use is not recommended.

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

Comments:
-No information is available on clinical use of this drug during breastfeeding.
-The developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
-Breastfeeding after the infusion of this drug should be discussed with the treating physician.

See references

Further information

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