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Long-term safety experience with bendamustine for injection in a real-world setting
Peter Martin1, Paul M Barr2, Leonard James3
1a Division of Hematology/Oncology , New York-Presbyterian/Weill Cornell Medicine , New York , NY , USA.
Expert Opinion on Drug Safety
|April 12, 2017
Summary
Bendamustine hydrochloride (bendamustine) safety data from pharmacovigilance reports led to label updates. Despite adverse events, bendamustine maintains a favorable risk-benefit profile for chronic lymphocytic leukemia and non-Hodgkin
Area of Science:
- Oncology
- Pharmacovigilance
- Hematology
Background:
- Bendamustine hydrochloride (bendamustine) is approved for chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin's lymphoma (NHL).
- Pharmacovigilance data collection enhances understanding of bendamustine's long-term safety.
- This overview details pharmacovigilance data leading to safety and administration label updates for bendamustine.
Purpose of the Study:
- To review pharmacovigilance data for bendamustine.
- To identify adverse events leading to label updates.
- To assess the safety profile of bendamustine in CLL and NHL patients.
Main Methods:
- Summarized adverse events (AEs) from 12 quarterly postmarketing reports (2008-2015).
- Classified AEs as serious/nonserious and expected/unexpected.
- Analyzed observational data from a large, heterogeneous patient population.
Main Results:
- Label updates were triggered by Stevens-Johnson syndrome, toxic epidermal necrolysis, extravasation, secondary neoplasm, and DRESS syndrome.
- Preventive measures for tumor lysis syndrome were revised.
- Reported AEs provide a comprehensive understanding of bendamustine's safety profile.
Conclusions:
- Bendamustine demonstrates a favorable risk-benefit profile based on observational data.
- Bendamustine remains a valuable treatment option for CLL and NHL management.
- Continued pharmacovigilance is crucial for understanding long-term safety.