Bendamustine Kabi

Bendamustine HCl

Patients w/ chronic lymphocytic leukaemia (CLL), relapsed/refractory indolent non-Hodgkin's lymphoma (NHL). Previously untreated indolent CD20-+ve, stage III-IV NHL in combination w/ rituximab & untreated CD20-+ve, stage III-IV mantle cell lymphoma (MCL) in combination w/ rituximab in patients ineligible for autologous stem cell transplantation.

IV infusion Administer over 30-60 min. Monotherapy: CLL 100 mg/m² on days 1 & 2 every 4 wk up to 6 cycles. Indolent NHL refractory to rituximab 120 mg/m² on days 1 & 2 every 3 wk for at least 6 cycles (max 8 cycles). Combination therapy w/ rituximab: 1st-line NHL & MCL 90 mg/m² on days 1 & 2 of 4-wk cycle for up to 6 cycles. Patients w/ moderate hepatic impairment (serum bilirubin 1.2-3 mg/dL) 30% dose reduction.

Hypersensitivity. Severe bone marrow suppression & blood count alterations (leukocyte &/or platelet values dropped to <3,000/µL or <75,000/µL, respectively). Jaundice. Major surgery <30 days before start of treatment. Infections especially involving leukocytopenia. Yellow fever vaccination. Severe hepatic impairment (serum bilirubin >3 mg/dL). Lactation.

Discontinue if signs of opportunistic infections occur; in progressive skin reactions. Not to be started treatment if leukocyte &/or platelet values dropped to <3,000/µL or <75,000/µL, respectively. Stop extravasal inj immediately. Closely monitor for signs & symptoms of active HBV infection throughout therapy & for several mth following termination of therapy. Malignancies (including myelodysplastic syndrome, myeloproliferative disorders, AML & bronchial cancer) & pre-malignant disease. Bacterial (sepsis, pneumonia) & opportunistic infections eg, Pneumocystis jirovecii pneumonia (PJP), varicella zoster virus (VZV) & cytomegalovirus (CMV). May cause prolonged lymphocytopenia (<600/µL) & low CD4-+ve T-cell (T-helper cell) counts (<200/µL) for at least 7-9 mth after treatment completion. Patients w/ lymphopenia & low CD4-+ve T-cell count following treatment; concurrent or history of cardiac disease. SJS, TEN & DRESS; MI & cardiac failure; tumour lysis syndrome; infusion reactions. Monitor leukocytes, platelets, Hb, & neutrophils at least wkly. Perform HBV infection test before treatment initiation. Closely monitor K conc & administer K supplement if K <3.5 mEq/L & perform ECG measurement in patients w/ cardiac disorders. Adequate vol status & closely monitor blood chemistry, particularly K & uric acid levels in patients w/ tumour lysis syndrome. May give antiemetic for symptomatic treatment of nausea & vomiting. Coadministration w/ allopurinol. May affect ability to drive & use machines. Severe hepatic impairment (serum bilirubin of >3 mg/dL). Severe renal impairment. Male patients should not father a child during & up to 6 mth after treatment. Women should not become pregnant during treatment. Women of childbearing potential must use effective contraception methods both before & during therapy. Not to be used during pregnancy. Childn.

Infection not otherwise specified including opportunistic infection (eg, herpes zoster, CMV, hepatitis B); leukopenia not otherwise specified, thrombocytopenia, lymphopenia; headache; nausea, vomiting; mucosal inflammation, fatigue, pyrexia; decrease Hb, increase creatinine & urea. Tumour lysis syndrome; haemorrhage, anaemia, neutropenia; hypersensitivity not otherwise specified; insomnia, dizziness; cardiac dysfunction (eg, palpitations, angina pectoris, arrhythmia); hypotension, HTN; pulmonary dysfunction; diarrhoea, constipation, stomatitis; alopecia, skin disorders not otherwise specified, urticaria; amenorrhea; pain, chills, dehydration, anorexia; hypokalemia, increased AST, ALT, alkaline phosphatase, bilirubin. SJS, TEN, DRESS.

Potentiated effect w/ myelosuppressive agents. Excessive immunosuppression w/ risk of lymphoproliferation w/ cyclosporine or tacrolimus. Reduced Ab formation following live virus vaccination w/ cytostatics. CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin, acyclovir & cimetidine.

Cytotoxic Chemotherapy

L01AA09 - bendamustine ; Belongs to the class of alkylating agents, nitrogen mustard analogues. Used in the treatment of cancer.

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