Is Lurbinectedin Contraindicated in Pregnancy?
Yes, lurbinectedin (Zepzelca) is contraindicated during pregnancy due to risks of embryo-fetal developmental toxicity and death. The prescribing information states it can cause fetal harm when administered to pregnant women, based on its mechanism as a DNA-damaging agent and animal reproduction studies showing embryolethality and malformations at doses lower than human equivalents.[1][2]
Evidence from Animal Studies
In rats and rabbits, lurbinectedin caused embryo-fetal death, reduced fetal weight, and skeletal/organ abnormalities at exposures 0.04-0.3 times the human clinical dose. No adequate human data exist, but the drug's genotoxic effects support the contraindication.[1]
Pregnancy Registry and Recommendations
Pregnant patients must be advised of the risk. A pregnancy exposure registry exists (contact 888-438-0435 or visit mothertobaby.org). Women of reproductive potential require contraception during treatment and for 6 months after the last dose; males need contraception for 4 months.[1][2]
What If Exposure Occurs?
Unintentional exposure warrants immediate pregnancy testing and counseling on risks, including fetal monitoring or termination discussion. Lactation is also contraindicated due to potential secretion.[1]
Related Regulatory Warnings
FDA pregnancy category not assigned (modern labels use narrative risk summaries). Similar DNA-targeted chemotherapies like trabectedin (related compound) carry identical warnings.[2]
Sources:
[1]: Zepzelca Prescribing Information (FDA)
[2]: Drugs.com - Lurbinectedin