See the DrugPatentWatch profile for lurbinectedin

Based on the information available, there is limited data regarding the risks of birth defects with Lurbinectedin use. Lurbinectedin is a novel antitumor agent, and its effects on pregnancy and fetal development have not been thoroughly studied. Therefore, it is crucial to exercise caution when considering the use of this medication during pregnancy.

According to the manufacturer's prescribing information, there are no well-controlled studies in pregnant women using Lurbinectedin [1]. Animal reproduction studies have demonstrated adverse developmental effects at maternal exposures that were significantly lower than human exposures at the recommended dose [1]. However, animal studies may not always predict the human response.

The National Library of Medicine's LactMed database states that there is no information regarding the presence of Lurbinectedin in human milk, the effects on the breastfed infant, or the effects on milk production [2].

In summary, the available information does not provide a definitive answer regarding the risks of birth defects with Lurbinectedin use. However, due to the lack of human data and potential risks observed in animal studies, it is advisable to avoid using Lurbinectedin during pregnancy and breastfeeding if possible. Consult a healthcare professional for personalized advice.

Sources:
[1] PharmaMar. (2021). ZEPZELCA (lurbinectedin) prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214537s000lbl.pdf
[2] National Library of Medicine. (2021). Lurbinectedin - drug record. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK557455/

(Note: DrugPatentWatch.com was not used as a source for this response.)