U.S. Food and Drug Administration Analysis of Newly Identified Adverse Events With Lurbinectedin: Extravasation, Rhabdomyolysis, and Tumor Lysis Syndrome

Author:

Kaland David A.ORCID,Dores Graça M.,Nayernama Afrouz,Camilli Sara

Publisher

Elsevier BV

Subject

Cancer Research,Pulmonary and Respiratory Medicine,Oncology

Reference28 articles.

1. Zepzelca (lurbinectedin) [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213702s004lbl.pdf.

2. Questions and Answers on FDA's Adverse Event Reporting System (FAERS). Available at: https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers. Accessed: May 6, 2022.

3. MedDRA. Introductory Guide: MedDRA version 24.0. Available at: https://www.meddra.org/how-to-use/support-documentation/english. Accessed: May 6, 2022.

4. Tumour lysis syndrome: new therapeutic strategies and classification;Cairo;Br J Haematol,2004

5. The Uppsala Monitoring Centre. The use of the WHO-UMC system for standardised case causality assessment. Available at: https://who-umc.org/media/164200/who-umc-causality-assessment_new-logo.pdf. Accessed: 13 April, 2022.

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1. Lurbinectedin/doxorubicin;Reactions Weekly;2023-03-11

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