Marnetegragene Autotemcel Interactions

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no available data from KRESLADI administration in pregnant women. No animal reproductive and developmental toxicity studies have been conducted to assess whether KRESLADI can cause fetal harm when administered to a pregnant woman. No nonclinical germline transmission studies have been conducted with KRESLADI. KRESLADI must not be administered during pregnancy because of the risk associated with conditioning. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.