|Toxicity grade||On Days 1 and 2,
reduce dose to*
|Hematologic toxicity||Initial||≥3||50 mg/m2|
|Non-hematologic toxicity||≥3||50 mg/m2|
General dosing considerations
- Delay treatment for Grade 4 hematologic toxicity or clinically significant ≥Grade 2 non-hematologic toxicity
- Once non-hematologic toxicity has recovered to ≤ Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 109 /L, platelets ≥ 75 x 109 /L], BELRAPZO can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted.
- Concomitant CYP1A2 inducers or inhibitors have the potential to affect the exposure of Bendamustine
- BELRAPZO® should not be used in patients with creatinine clearance (CrCL) less than 30 mL/min
- BELRAPZO® should not be used in patients with moderate (AST or ALT 2.5-10 X ULN and total bilirubin 1.5-3 X ULN) or severe (total bilirubin greater than 3 X ULN) hepatic impairment
Dose adjustment and treatment monitoring
Delay treatment for Grade 4 hematologic toxicity or clinically significant Grade 2 or greater non-hematologic toxicity. In the event that myelosuppression occurs, dose delays and/or dose reductions may be needed if recovery to the recommended values has not been met by the first day of the next scheduled cycle.
It is important to monitor patients closely in the event that an infusion reaction occurs. Fatal and serious skin reactions have been reported. In rare cases, severe anaphylactic and anaphylactoid reactions have occurred, specifically in the second and subsequent cycles of therapy.
In the event of treatment-related myelosuppression, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. In the clinical trials, blood counts were monitored every week initially. Hematologic nadirs were observed predominantly in the third week of therapy. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle. Prior to the initiation of the next cycle of therapy, the ANC should be ≥1 x 109/L and the platelet count should be ≥75 x 109/L.
Prepare when needed
BELRAPZO® is supplied as a ready-to-dilute solution
The final admixture is stable for
(2°C to 8°C or 36°F to 46°F)
when stored at room temperature
(15°C to 30°C or 59°F to 86°F)
Partially used vials are
stable for up to 28 days
when stored in their original cartons under refrigeration
(2°C to 8°C or 36°F to 46°F)
- After first use, the partially used vial should be stored in original carton at 2°C to 8°C (36°F to 46°F), and then discarded after 28 days
- Each vial is not recommended for more than a total of six (6) dose withdrawals
Two diluent options
- 0.9% Sodium Chloride
- 2.5% Dextrose/0.45%
|Body Surface Area (m2)||Volume (mL) of BELRAPZO® required|
|120 mg/m2||100 mg/m2||90 mg/m2||60 mg/m2||50 mg/m2||25 mg/m2|