Betibeglogene autotemcel Pregnancy Warnings
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.
Safety has not been established during pregnancy.
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this product in pregnant women to inform a drug product-related risk.
Comments:
-Females of reproductive potential should be tested for pregnancy before starting treatment with this drug.
-Ensure a negative serum pregnancy test before mobilization and confirm pregnancy again before initiating conditioning procedures and drug product administration.
-This drug should not be administered to women who are pregnant.
-Consider the risks of myeloablative chemotherapy agents during pregnancy.
-Advise patients to consult their physician if they plan to become pregnant after receiving this product.
-Males with female partners of reproductive potential should be advised to use effective contraception from the start of mobilization and for at least 6 months after the drug product administration.
-Appraise patients of the risks associated with conditioning agents.
-Advise patients to cryopreserve semen or ova if appropriate before treatment, due to the risk of infertility with myeloablative conditioning.
See references
Betibeglogene autotemcel Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-The effects on the nursing infant are unknown.
-Benefit to mother should outweigh risk to the infant.
-This drug is not recommended for women who are breastfeeding.
-Breastfeeding, after receiving an infusion of this drug, should be discussed with the treating physician.
See references
