ASH Clinical News Focus on Myeloid Malignancies | Page 5

BENDEKA ® allows patients time off active treatment 1
Recommended dosage for BENDEKA for CLL is 100 mg/m 2 administered intravenously on Days 1 and 2
For CLL
10 MINUTES
For iNHL that
has progressed
2 DAYS
28 -DAY CYCLE
UP TO 6 CYCLES
Recommended dosage for BENDEKA for iNHL is 120 mg/m 2 administered intravenously on Days 1 and 2*
10 MINUTES
2 DAYS
21 -DAY CYCLE
UP TO 8 CYCLES
BENDEKA is indicated for the treatment of patients with
• Chronic lymphocytic leukemia (CLL). Effi cacy relative to fi rst-line therapies other than chlorambucil has not been established.
• Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a
rituximab-containing regimen.
*See Safety Information and additional dosing below.
Important Safety Information (cont’d) Dose modifi cations 1
Extravasation Injury: Bendamustine HCl extravasations have
been reported in post-marketing resulting in hospitalizations
from erythema, marked swelling, and pain. Assure good venous
access prior to starting BENDEKA infusion and monitor the
intravenous infusion site for redness, swelling, pain, infection,
and necrosis during and after administration of BENDEKA.
Embryo-fetal Toxicity: Bendamustine HCl can cause fetal harm
when administered to a pregnant woman. Women should be
advised to avoid becoming pregnant while using BENDEKA.
Most Common Adverse Reactions:
Adverse reactions (frequency >5%) during infusion and within
24 hours post-infusion are nausea and fatigue.
Most common non-hematologic adverse reactions for CLL
(frequency ≥15%) are pyrexia, nausea, and vomiting.
Most common non-hematologic adverse reactions for NHL
(frequency ≥15%) are nausea, fatigue, vomiting, diarrhea,
pyrexia, constipation, anorexia, cough, headache, weight
decreased, dyspnea, rash, and stomatitis.
Most common hematologic abnormalities (frequency ≥15%)
are lymphopenia, anemia, leukopenia, thrombocytopenia,
and neutropenia. CLL: For Grade ≥3 hematologic toxicity or clinically signifi cant Grade
≥3 non-hematologic toxicity, reduce the dose to 50 mg/m 2 on Days 1
and 2 of each cycle; if Grade ≥3 hematologic toxicity recurs, reduce
the dose to 25 mg/m 2 on Days 1 and 2 of each cycle. Dose
re-escalation may be considered.
iNHL: For Grade 4 hematologic toxicity, reduce the dose to 90 mg/m 2
on Days 1 and 2 of each cycle; if Grade 4 hematologic toxicity recurs,
reduce the dose to 60 mg/m 2 on Days 1 and 2 of each cycle. For
Grade ≥3 non-hematologic toxicity, reduce the dose to 90 mg/m 2 ; if
Grade ≥3 non-hematologic toxicity recurs, reduce the dose to 60 mg/m 2
on Days 1 and 2 of each cycle.
•
•
•
•
Reference: 1. BENDEKA® (bendamustine hydrochloride) injection [Current
Prescribing Information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.
Please see Brief Summary of Full Prescribing
Information on following pages.
BENDEKA® is a registered trademark of Cephalon, Inc.
©2017 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical
Industries Ltd. All rights reserved. BEN-40470 April 2017. Printed in USA.
Additional dosing considerations 1
• Delay treatment for Grade 4 hematologic toxicity or clinically
signifi cant ≥Grade 2 non-hematologic toxicity
• Store BENDEKA at recommended refrigerated storage conditions
(2-8°C or 36-46°F). When refrigerated the contents may partially
freeze. Allow the vial to reach room temperature (15-30°C or
59-89°F) prior to use
• Dilute BENDEKA injection prior to infusion
• Concomitant CYP1A2 inducers or inhibitors have the potential
to affect the exposure of bendamustine
• Renal impairment: Do not use if CrCL is <40 mL/min. Use with
cautio n in lesser degrees of renal impairment
• Hepatic impairment: Do not use in moderate or severe hepatic
impairment. Use with caution in mild hepatic impairment
For more information, visit BENDEKAHCP.com