Lurbinectedin Interactions

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Based on animal data and its mechanism of action [see Clinical Pharmacology (12.1) ] , ZEPZELCA can cause fetal harm when administered to a pregnant woman. There are no available data to inform the risk of ZEPZELCA use in pregnant women. Intravenous administration of a single lurbinectedin dose (approximately 0.2 times the 3.2 mg/m 2 clinical dose) to pregnant rats during the period of organogenesis caused embryolethality (see Data) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Data Animal Data In a reproductive toxicity study, administration of a single lurbinectedin dose of 0.6 mg/m 2 (approximately 0.2 times of the human dose of 3.2 mg/m 2 ) to pregnant rats on Gestation Day 10 resulted in 100% post-implantation loss.