Risk of myelosuppression; infection; reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus,
Mycobacterium tuberculosis, & herpes zoster; progressive multifocal leukoencephalopathy primarily in combination w/ rituximab or obinutuzumab; infusion reactions; tumor lysis syndrome. Reports of fatal & serious skin reactions including toxic skin reactions (SJS, TEN, DRESS), bullous exanthema, & rash; fatal & serious cases of liver injury; pre-malignant & malignant diseases including myelodysplastic syndrome, myeloproliferative disorders, AML, bronchial carcinoma, & non-melanoma skin cancer, including basal cell carcinoma & squamous cell carcinoma. Frequently monitor CBC, including leukocytes, platelets, Hb, & neutrophils. Discontinue treatment in case of grade 4 infusion reactions. Monitor liver chemistry tests prior to & during bendamustine therapy. Avoid extravasation; assure good venous access prior to starting infusion & monitor IV infusion site for redness, swelling, pain, infection, & necrosis during & after administration. Do not use in patients w/ CrCl <30 mL/min, & in patients w/ AST or ALT 2.5-10 times ULN & total bilirubin 1.5-3 times ULN, or total bilirubin >3 times ULN. May impair male fertility. Can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use an effective method of contraception during treatment & for at least 6 mth after final dose. Advise males w/ female partners of reproductive potential to use effective contraception during treatment & for at least 3 mth after final dose. Breastfeeding is not recommended during treatment & for at least 1 wk after last dose. Safety & effectiveness in ped patients have not been established.
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