Long-term safety experience with bendamustine for injection in a real-world setting

ABSTRACT

Background: Bendamustine hydrochloride (bendamustine) was approved for first-line treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent B-cell non-Hodgkin’s lymphoma (NHL). Pharmacovigilance data have been collected since bendamustine’s approval to enhance understanding of its long-term safety profile. Here we provide an overview of the pharmacovigilance data for bendamustine that have led to label updates related to safety and administration since its approval.

Research design and methods: Adverse events (AEs) captured from 12 quarterly postmarketing periodic adverse drug experience reports spanning 2008–2015 were included and summarized. AEs were classified as serious or nonserious and expected or unexpected.

Results: Adverse events that resulted in label updates included Stevens-Johnson syndrome, toxic epidermal necrolysis, extravasation, secondary neoplasm, and drug reactions with eosinophilia and systemic symptoms. Preventive measures for tumor lysis syndrome were revised. Although this review may be limited by voluntary reporting, the adverse events reported for bendamustine in a large, heterogeneous population with a long follow-up relative to recently approved treatments provide a much broader understanding of its safety profile.

Conclusions: Based on these observational data, bendamustine appears to have a favorable risk-benefit profile and remains a useful option when considering a management strategy in patients with CLL and NHL.

KEYWORDS:

• Bendamustine
• pharmacovigilance
• postmarketing
• surveillance

Declaration of interest

Ada Ao-Baslock, PhD, Powered 4 Significance LLC provided medical writing assistance with financial support from Teva Branded Pharmaceutical Products R&D. P Martin received research funding from Teva Pharmaceuticals during preparation of this manuscript. L James and A Pathak report employment by Teva Pharmaceuticals for conduct of the study or preparation of this manuscript. B Kahl reports consulting fees from Teva Pharmaceuticals during the conduct of the study. Astellas Pharma US, Inc. provided medical review of the paper. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

The study was supported by Teva Branded Pharmaceutical Products R&D.