- Clinical Practice (http://dev-voice.ons.org/topic/clinical-practice)
- Oncology Drug Research (http://dev-voice.ons.org/topic/oncology-drug-research)
- U.S. Food and Drug Administration (FDA) (http://dev-voice.ons.org/topic/us-food-and-drug-administration-fda)
- Drug Reference Sheets (http://dev-voice.ons.org/topic/drug-reference-sheets)
Oncology Drug Reference Sheet: Lurbinectedin
In June 2020, the U.S. Food and Drug Administration granted accelerated approval (https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer) to lurbinectedin (ZepzelcaTM) for adults with metastatic small cell lung cancer (SCLC) whose disease has progressed on or after platinum-based chemotherapy. The approval adds a second choice for patients who experience treatment-resistant SCLC progression, who previously had only topotecan as an option.
Category/Class
Alkylating antineoplastic agent
Indication
Adults with metastatic SCLC with disease progression on or after platinum-based chemotherapy
Dosing
3.2 mg/m2 every 21 days
Administration
Give via IV infusion over 60 minutes. Premedication with corticosteroids and serotonin antagonists should be considered for antiemetic prophylaxis.
Adverse Reactions
More than 20% of patients experienced laboratory abnormalities (e.g., leukopenia, lymphopenia, neutropenia, anemia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, decreased albumin, decreased sodium, increased aspartate aminotransferase, decreased magnesium), fatigue, nausea, decreased appetite, musculoskeletal pain, constipation, dyspnea, vomiting, cough, and diarrhea. Lurbinectedin carries warnings and precautions (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf) for myelosuppression, hepatotoxicity, and embryo-fetal toxicity.
Nursing Considerations
Monitor laboratory values throughout treatment. Neutropenia, thrombocytopenia, and hepatotoxicity may require dose modifications. (Refer to the prescribing information for guidance on dose modifications.) Verify pregnancy status of patients with reproductive potential prior to starting lurbinectedin. Men with female partners of reproductive potential should use effective contraception during treatment and for four months after the final dose.
Drug-drug and drug-food interactions: Strong and moderate CYP3A inhibitors increase lurbinectedin systemic exposure and may result in increased incidence and severity of adverse reactions. Strong and moderate CYP3A inducers may decrease lurbinectedin’s efficacy. Avoid grapefruit and grapefruit juice while on treatment.
Patient Education
Avoid pregnancy and do not breastfeed while on lurbinectedin. Alert the care team if you develop fever, signs of infection, unusual bruising, bleeding, tiredness, or pallor. Report any symptoms of hepatotoxicity, including jaundice, stomach pain, appetite loss, and light-colored bowel movements. Report use of any medications and herbal and dietary supplements because of the potential for drug-drug interactions.
Gero-Oncology Considerations
No overall differences in effectiveness were observed in clinical trials in patients older than 65; however, the incidence of serious adverse reactions largely related to myelosuppression (e.g., febrile neutropenia, neutropenia, thrombocytopenia, anemia) was higher than in those younger than 65.
Safe Handling
Lurbinectedin is a hazardous drug (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf). Use safe handling protocols.
Patient Assistance
A financial assistance program is available by calling 833-533-5299.