Is lurbinectedin safe during pregnancy?
Lurbinectedin (Zepzelca) carries significant pregnancy risks. It is classified as pregnancy category D, meaning animal studies show fetal harm and human risks outweigh benefits unless no alternatives exist.[1] The drug's label warns it can cause fetal harm based on its mechanism as a DNA-binding agent that disrupts cell division, similar to chemotherapy effects observed in animal models.[2]
What do animal studies show?
In rats and rabbits, lurbinectedin at doses below human equivalents caused embryo-fetal toxicity, including reduced fetal weight, skeletal abnormalities, and increased resorptions. No formal fertility studies exist, but ovarian atrophy occurred in female rats.[1][2]
Recommendations for pregnant patients or those planning pregnancy
Avoid use during pregnancy. Women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose. Men with partners of childbearing potential should use contraception during treatment and for 4 months post-dose. Verify pregnancy status before starting.[2]
What if accidental exposure happens during pregnancy?
Report to the Zepzelca Pregnancy Exposure Registry (1-888-438-4239) or FDA (1-800-FDA-1088). Limited human data exists, but genotoxic effects suggest monitoring for fetal anomalies via ultrasound or amniocentesis.[1][2]
Breastfeeding risks
Do not breastfeed during treatment and for 2 weeks after the last dose due to potential excretion in milk and infant harm.[2]
Sources
[1] Drugs.com - Lurbinectedin
[2] FDA Label - Zepzelca (lurbinectedin)