Exagamglogene autotemcel Pregnancy and Breastfeeding Warnings

Brand names: Casgevy

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

Exagamglogene autotemcel Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: Due to the risks associated with myeloablative conditioning, administration of this drug during pregnancy is not recommended.

Comments:
-No data available on use of this drug in pregnant women to inform a drug-related risk.
-Negative pregnancy status must be verified in females of childbearing potential prior to the start of each mobilization cycle and re-confirmed prior to myeloablative conditioning.
-Women of childbearing potential and males of reproductive potential must use effective contraception from the start of mobilization through at least 6 months after administration of this drug.
-Pregnancy after therapy with this drug should be discussed with the treating physician.
-Although there are no data on the effects of this drug on human fertility, infertility has been observed with myeloablative conditioning.
-Patients should be advised of fertility preservation options before treatment with this drug, if appropriate.

Animal studies have not been reported. There are no studies conducted to assess whether this drug causes fetal harm or effects on fertility. 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

Exagamglogene autotemcel Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-Women are advised not to breastfeed during myeloablative conditioning due to the potential for serious adverse effects.
-There are no data on the presence of this drug, its 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 and potential adverse effects on the infant.
-Breastfeeding after treatment with this drug should be discussed with the treating physician.

See references

Further information

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