Ciltacabtagene autoleucel Pregnancy and Breastfeeding Warnings

Brand names: Carvykti

Ciltacabtagene autoleucel Pregnancy Warnings

Use is not recommended in pregnant patients or patients of childbearing potential not using contraception.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk; based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity (including B-cell lymphocytopenia and hypogammaglobulinemia).

Comments:
-Before starting this drug, pregnancy status should be verified for patients of childbearing potential.
-If this drug is used during pregnancy, the patient should be apprised of the potential harm to the fetus.
-Pregnant patients who have received this drug may have hypogammaglobulinemia; assessment of immunoglobulin levels in newborns of mothers treated with this drug should be considered.
-Pregnancy after use of this drug should be discussed with the treating physician.
-Insufficient data are available to provide recommendations regarding duration of contraception after use of this drug.
---In clinical trials, patients of childbearing potential were advised to use a highly effective method of contraception and male patients with partners of childbearing potential or whose partners were pregnant were instructed to use a barrier method of contraception, until 1 year after the patient received an infusion of this drug.
-The manufacturer product information for lymphodepleting chemotherapy should be consulted for information on contraception requirements in patients receiving the lymphodepleting chemotherapy.

Animal studies have not been reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

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Ciltacabtagene autoleucel Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---Patients who are breastfeeding should be advised of the potential harm to nursing infants.
-According to some authorities: After administration of this drug, the decision to breastfeed should be discussed with the treating physician.

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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