Ribomustin

Ribomustin Adverse Reactions

bendamustine

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
The most common adverse reactions with bendamustine hydrochloride are hematological adverse reactions (leukopenia, thrombopenia), dermatologic toxicities (allergic reactions), constitutional symptoms (fever), gastrointestinal symptoms (nausea, vomiting).
The table as follows reflects the data obtained with bendamustine hydrochloride in clinical trials. (See table.)

Click on icon to see table/diagram/image

A small number of cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in patients some using bendamustine in combination with allopurinol or in combination with allopurinol and rituximab. In addition, a few cases of hepatitis B reactivation resulting in hepatic failure have been reported in patients treated with bendamustine. Pancytopenia, headache, dizziness, opportunistic infection (e.g. herpes zoster, cytomegalovirus, pneumocystis jirovecii pneumonia), bone marrow failure, hepatic failure, renal failure, nephrogenic diabetes insipidus, drug reaction with eosinophilia and systemic symptoms (combination therapy with rituximab) have also been reported in patients treated with bendamustine.
The CD4/CD8 ratio may be reduced. A reduction of the lymphocyte count was seen. In immunosuppressed patients, the risk of infection (e.g., with herpes zoster) may be increased.
There have been isolated reports of necrosis after accidental extra-vascular administration, tumor lysis syndrome, and anaphylaxis.
The risk of myelodysplastic syndrome and acute myeloid leukaemias is increased in patients treated with alkylating agents (including bendamustine). The secondary malignancy may develop several years after chemotherapy has been discontinued.
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