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U.S. Department of Health and Human Services

Safety

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Treanda (bendamustine hydrochloride) lyophilized solid for injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010 and June 2012

 

Summary View

 

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • Treanda was evaluated in a single Phase 1/2 trial in pediatric patients with leukemia. The safety profile for Treanda in pediatric patients was consistent with that seen in adults, and no new safety signals were identified.
  • The trial included pediatric patients from 1-19 years of age with relapsed or refractory acute leukemia, including 27 patients with acute lymphocytic leukemia (ALL) and 16 patients with acute myeloid leukemia (AML). Treanda was administered as an intravenous infusion over 60 minutes on Days 1 and 2 of each 21-day cycle. Doses of 90 and 120 mg/m2 were evaluated. The Phase 1 portion of the study determined that the recommended Phase 2 dose of TREANDA in pediatric patients was 120 mg/m2.
  • A total of 32 patients entered the Phase 2 portion of the study at the recommended dose and were evaluated for response. There was no treatment response (CR+ CRp) in any patient at this dose. However, there were 2 patients with ALL who achieved a CR at a dose of 90 mg/m2 in the Phase 1 portion of the study.
  • In the above-mentioned pediatric trial, the pharmacokinetics of Treanda at 90 and 120 mg/m2 doses were evaluated in 5 and 38 patients, respectively, aged 1 to 19 years (median age of 10 years).
  • The geometric mean body surface adjusted clearance of bendamustine was 14.2 L/h/m2. The exposures (AUC0-24 and Cmax) to bendamustine in pediatric patients following a 120 mg/m2 intravenous infusion over 60 minutes were similar to those in adult patients following the same 120 mg/m2 dose.

 

December 2010

Summary View

 

ADVERSE REACTIONS

Post-Marketing Experience
  • injection or infusion site reactions including phlebitis