Bendalab ® Injection 100 mg
(Bendamustine Hydrochloride 100mg)
GENERIC NAME: Bendamustine Hydrochloride 100mg Injection
THERAPEUTIC CLASS: Alkylating agents
INDICATIONS & DOSAGE:
- Chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
- Indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen
STORAGE:Store at 2-8°C. Protect from light.
PACK SIZE: 1×1’s
DOSAGE & ADMINISTRATION:
For CLL:
- 100 mg/m2 infused intravenously over 30 minutes on Days 1 and 2 of a 28 day cycle, up to 6 cycles
- Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce dose to 50 mg/m2 on Days 1 and 2; if Grade 3 or greater toxicity recurs, reduce dose to 25 mg/m2 on Days 1 and 2.
- Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle.
- Dose re-escalation may be considered.
For NGL:
- 120 mg/m2 infused intravenously over 60 minutes on Days 1 and 2 of a 21 day cycle, up to 8 cycles
- Dose modifications for hematologic toxicity: for Grade 4 toxicity, reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle; if Grade 4 toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.
- Dose modifications for non-hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.
General Dosing Considerations:
- Delay treatment for Grade 4 hematologic toxicity or clinically significant ≥ Grade 2 non-hematologic toxicity
- Bendamustine for Injection must be reconstituted and further diluted prior to infusion.