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What are the risks of using lurbinectedin while pregnant?



Lurbinectedin is a chemotherapy drug used to treat metastatic small cell lung cancer. According to the FDA, Lurbinectedin can cause fetal harm when administered to a pregnant woman. It is classified as a Pregnancy Category D drug, which means there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. The FDA recommends that women of childbearing potential use effective contraception during treatment with Lurbinectedin and for at least 6 months after the last dose [2].

The drug patent watch website provides information on Lurbinectedin’s clinical trials, patents, and exclusivities. It also states that Lurbinectedin is not recommended for use in pregnant women. The website further notes that Lurbinectedin is contraindicated in patients with a history of severe hypersensitivity reactions to the drug [1].

The Mayo Clinic website lists several side effects of Lurbinectedin, including nausea, vomiting, loss of appetite, fatigue, hair loss, constipation, and anemia. It also warns that Lurbinectedin can cause serious side effects, such as low white blood cell count, which can increase the risk of infection, and low platelet count, which can increase the risk of bleeding. Additionally, Lurbinectedin can cause liver damage, which can be fatal in some cases. Patients should inform their healthcare provider immediately if they experience any symptoms of liver damage, such as yellowing of the skin or eyes, dark urine, or pain in the upper right part of the abdomen. The website does not specifically mention the risks of using Lurbinectedin while pregnant, but it does note that the drug can harm a developing fetus [3].

In conclusion, Lurbinectedin is not recommended for use in pregnant women as it can cause fetal harm. Women of childbearing potential should use effective contraception during treatment with Lurbinectedin and for at least 6 months after the last dose. Lurbinectedin can also cause serious side effects, such as low white blood cell count, low platelet count, and liver damage. Patients should inform their healthcare provider immediately if they experience any symptoms of liver damage. [1][2][3]

Sources:
[1] https://www.drugpatentwatch.com/p/tradename/LURBINECTEDIN
[2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf
[3] https://www.mayoclinic.org/drugs-supplements/lurbinectedin-intravenous-route/side-effects/drg-20490804?p=1



Follow-up:   Is lurbinectedin safe for fetal development? Can lurbinectedin harm the unborn child? Are there any known birth defects associated with lurbinectedin?





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