Bendamustine Mylan

Bendamustine Mylan







Concise Prescribing Info
Bendamustine HCl
Patients w/ chronic lymphocytic leukemia (CLL); indolent B-cell non-Hodgkin's lymphoma (NHL) progressed during or following rituximab therapy or rituximab-containing regimen.
Dosage/Direction for Use
IV CLL 100 mg/m2 over 30 min on Days 1 & 2 of 28-day cycle up to 6 cycles. Dose modifications: ≥Grade 3 hematologic/non-hematologic toxicity Reduce dose to 50 mg/m2 on Days 1 & 2 of each cycle. Further reduce dose to 25 mg/m2 on Days 1 & 2 of each cycle if hematologic toxicity recurs. NHL 120 mg/m2 over 60 min on Days 1 & 2 of 21-day cycle up to 8 cycles. Dose modifications: Grade 3 non-hematologic & Grade 4 hematologic toxicity Reduce dose to 90 mg/m2 on Days 1 & 2 of each cycle. Further reduce dose to 60 mg/m2 on Days 1 & 2 of each cycle if both toxicity recurs.
Hypersensitivity eg, anaphylactic or anaphylactoid reactions.
Special Precautions
Discontinue use if severe anaphylactic & anaphylactoid reactions occur; in patients w/ Grade 3 or 4 infusion reactions. Withhold or discontinue in severe or progressive skin reactions. Delay treatment for Grade 4 hematologic or ≥Grade 2 non-hematologic toxicity. Myelosuppression. Infection including pneumonia & sepsis. Tumor lysis syndrome; Stevens-Johnson syndrome, toxic epidermal necrolysis. Skin reactions eg, rash, toxic skin reactions & bullous exanthema. Pre-malignant & malignant diseases including myelodysplastic syndrome, myeloproliferative disorders, AML & bronchial asthma. Closely monitor leukocytes, platelets, Hb & neutrophils wkly; blood chemistry eg, K & uric acid levels; hepatitis virus markers after initiation of treatment. Maintain adequate vol status. Test for hepatitis B infection prior to initiation of therapy. Perform regular liver function test. Increased risk of severe skin toxicity w/ allopurinol. Concomitant use w/ other anticancer agents; rituximab. May affect ability to drive & use machines. Fetal harm to pregnant woman. Lactation.
Adverse Reactions
Pyrexia, nausea, vomiting, fatigue, constipation, anorexia, cough, headache, decreased wt, stomatitis; lymphopenia, anemia, leukopenia, thrombocytopenia & neutropenia. Myelosuppression; infections; infusion reactions & anaphylaxis; tumor lysis syndrome; skin reactions; other malignancies; HBV reactivation. Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
Increased plasma conc w/ CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin. Decreased plasma conc w/ CYP1A2 inducers eg, omeprazole, smoking.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01AA09 - bendamustine ; Belongs to the class of alkylating agents, nitrogen mustard analogues. Used in the treatment of cancer.
Bendamustine Mylan powd for infusion 100 mg
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