Belrapzo (bendamustine hydrochloride) Injection

Side effects of Belrapzo include:

• nausea,
• fatigue,
• low iron (anemia),
• low platelet count (thrombocytopenia),
• low white blood cells (neutropenia, lymphopenia, leukopenia),
• too much bilirubin in the blood (hyperbilirubinemia),
• fever,
• vomiting
• diarrhea,
• constipation,
• weight loss,
• cough,
• headache,
• shortness of breath,
• rash, and
• inflammation of the mouth and lips

Recommended Dosage

The recommended dose is 100 mg/m² administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

Dose Delays, Dose Modifications And Reinitiation Of Therapy For CLL

• Delay Belrapzo administration in the event of Grade 4 hematologic toxicity or clinically significant Grade 2 or greater non-hematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 10⁹/L, platelets ≥ 75 x 10⁹/L], reinitiate Belrapzo at the discretion of the treating physician. In addition, consider dose reduction.
• Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 50 mg/m² on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m² on Days 1 and 2 of each cycle.
• 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.
• Consider dose re-escalation in subsequent cycles at the discretion of the treating physician.

Dosing Instructions For NHL

Recommended Dosage

The recommended dose is 120 mg/m² administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.

Dose Delays, Dose Modifications And Reinitiation Of Therapy For NHL

• Delay Belrapzo administration in the event of a Grade 4 hematologic toxicity or clinically significant greater or equal to 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], reinitiate Belrapzo at the discretion of the treating physician. In addition, consider dose reduction.
• 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.

Effect Of Other Drugs On Belrapzo

CYP1A2 Inhibitors

• The coadministration of Belrapzo with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with Belrapzo.
• Consider alternative therapies that are not CYP1A2 inhibitors during treatment with Belrapzo.

CYP1A2 Inducers

• The coadministration of Belrapzo with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of Belrapzo.
• Consider alternative therapies that are not CYP1A2 inducers during treatment with Belrapzo.

• In animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (MRHD) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth.
• There are no available data on bendamustine hydrochloride use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• There are no data on the presence of bendamustine hydrochloride or its metabolites in either human or animal milk, the effects on the breastfed child, or the effects on milk production.
• Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with Belrapzo, and for at least 1 week after the last dose.