Ciltacabtagene autoleucel Pregnancy Warnings
No reproductive and developmental toxicity studies in animals have been conducted with this drug to assess whether it can cause fetal harm when administered to a pregnant woman.
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.
US FDA pregnancy category: Not assigned
Comments:
-There is no data on use in pregnant women to know this drug's risks, including the risk of fetal harm or reproductive effects.
-Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia and hypogammaglobulinemia.
-This drug is not recommended for women who are pregnant, or for women of childbearing potential not using contraception.
-Female patients of childbearing potential are advised to use a highly effective method of contraception. Male patients with partners of childbearing potential or whose partners are pregnant should use a barrier method of contraception, until one year after the patient has received treatment with this drug.
-See the prescribing information for lymphodepleting chemotherapy for information on the need for contraception in patients who receive the lymphodepleting chemotherapy.
See references
Ciltacabtagene autoleucel Breastfeeding Warnings
Benefit should outweigh risk.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
See references
