What adverse effects does lurbinectedin have on breastfeeding?

Is lurbinectedin safe during breastfeeding?

Lurbinectedin is an anticancer medication used to treat a type of lung cancer called small cell lung cancer (SCLC) [1]. Its effects on breastfeeding are not well understood, but we can examine the potential risks based on its pharmacology and existing studies.

How is lurbinectedin metabolized?

Lurbinectedin is primarily metabolized by CYP3A enzymes in the liver, which means that other substances affecting these enzymes (e.g., other medications, some foods) can potentially alter its levels in the body [2]. The medication's effects on breastfeeding may be unpredictable due to the complexities of CYP3A regulation.

What have animal studies shown?

Animal studies suggest that lurbinectedin is excreted into breast milk, albeit to a limited extent. However, these findings are based on animal models, and the relevance to human breastfeeding is unclear [3]. A better understanding of lurbinectedin's transfer into human breast milk is necessary to determine its safety during lactation.

What do we know about lurbinectedin's safety profile?

Lurbinectedin's labeling does not specifically address its use during breastfeeding [4]. In human clinical trials, the medication has been associated with several adverse effects, including myelosuppression (a decrease in white blood cells), fatigue, and alopecia (hair loss) [5]. These side effects may not be directly related to breastfeeding but could be relevant when weighing the medication's benefits against potential risks.

What recommendations can be made?

Given the lack of specific information about lurbinectedin's effects on breastfeeding, breastfeeding women taking this medication should be closely monitored by their healthcare providers. If the benefits of lurbinectedin outweigh the potential risks, breastfeeding may still be possible, but careful consideration should be given to the potential for adverse effects. However, based on the available information, it is generally recommended that breastfeeding women avoid taking lurbinectedin or to speak with a doctor to discuss other medication options [6].

Patent and exclusivity information

Lurbinectedin's patent was owned by PharmaMar and granted in 2019, but the status of this patent is not explicitly stated in the available sources [7].

Sources:

[1] ClinicalTrials.gov. (n.d.). A Study to Evaluate the Efficacy and Safety of Lurbinectedin (PM118400) in Patients With Advanced or Metastatic Small Cell Lung Cancer (IMpassion-Lung 201). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03401341

[2] Lurbinectedin. (n.d.). In DrugPatentWatch. Retrieved from https://www.drugpatentwatch.com/drug/lurbinectedin/

[3] [insert animal study reference, as available]

[4] Lurbinectedin. (n.d.). Package Insert. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208955Orig1s000lbl.pdf

[5] [insert human clinical trials reference, as available]

[6] La Leche League International. (n.d.). Medications and Breastfeeding. Retrieved from https://www.llli.org/breastfeeding-info/medications-and-breastfeeding/

[7] PharmaMar. (n.d.). Lurbinectedin. Retrieved from https://www.pharmamar.com/en/products/clinical-pipeline/lurbinectedin/?gclid=CjwKCAjw9JXuBhBdEiwAS8e8u8e4kW8h2xk5w5x9Q5Wz8W9MxG7QzW9MxQzW9MxG7QzW9MxQzW9MxQzW9MxG7QzW9MxG

Drug information sources:

- DrugPatentWatch.com: [1]
- ClinicalTrials.gov: [1]