See the DrugPatentWatch profile for lurbinectedin

There is limited information available on the effects of Lurbinectedin use during pregnancy, as it has not been extensively studied in this context. However, based on the available information, there is a potential risk of birth defects associated with Lurbinectedin use during pregnancy.

Lurbinectedin is a chemotherapeutic drug that is used to treat small cell lung cancer. It works by inhibiting the transcription of genes that are necessary for the growth and survival of cancer cells. However, like many chemotherapeutic drugs, Lurbinectedin can also affect rapidly dividing cells in the body, including those in the developing fetus.

According to the manufacturer's prescribing information, Lurbinectedin can cause fetal harm when administered to a pregnant woman. There are reports of birth defects in animals that were exposed to Lurbinectedin during pregnancy. However, it is important to note that animal studies may not always predict the effects of a drug in humans.

The lack of human data on the use of Lurbinectedin during pregnancy makes it difficult to fully assess the risk of birth defects. Therefore, the manufacturer recommends that Lurbinectedin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is also important to note that Lurbinectedin is classified as a Category D drug by the FDA, which means that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

In summary, based on the available information, there is a potential risk of birth defects associated with Lurbinectedin use during pregnancy. However, the lack of human data makes it difficult to fully assess the risk. Therefore, Lurbinectedin should be used during pregnancy only if the potential benefit outweighs the potential risk.

Sources:

1. Lurbinectedin (Zepzelca) prescribing information. <https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214437s000lbl.pdf>
2. DrugPatentWatch.com. Lurbinectedin. <https://www.drugpatentwatch.com/drugs/lurbinectedin>