cases were reported within the first three months of starting therapy. Monitor liver chemistry tests prior to and during BENDEKA therapy.
Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with bendamustine HCl, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with BENDEKA has not been determined.
Extravasation Injury: Bendamustine HCl extravasations have been reported in post-marketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting BENDEKA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of BENDEKA.
Embryo-fetal Toxicity: Bendamustine HCl can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using BENDEKA.
Most Common Adverse Reactions:
•Adverse reactions (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue.•Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.•Most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.•Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.
1）：http://www.bendeka.com/Pdf/PrescribingInformation.PDF
2）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ace9a43b-f9bd-4896-abfe-0ef4fec67ddf |
