Bendamustine Side Effects

Some side effects of bendamustine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bendamustine: intravenous powder for injection

Some people receiving a bendamustine injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have fever, chills, itching, or skin rash during or shortly after the injection.

Get emergency medical help if you have any of these signs of an allergic reaction while taking bendamustine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising or bleeding, purple or red pinpoint spots under your skin, unusual weakness;

• cold symptoms such as stuffy nose, sneezing, cough, sore throat;

• lower back pain, blood in your urine, urinating less than usual or not at all;

• numbness or tingly feeling around your mouth;

• muscle weakness, tightness, or contraction, overactive reflexes;

• fast or slow heart rate, weak pulse, confusion;

• dry mouth, feeling very thirsty or hot, heavy sweating or hot and dry skin;

• severe blistering, peeling, and red skin rash; or

• pain, swelling, redness, skin changes, or signs of infection where the medicine was injected.

Common side effects may include:

• mild nausea, vomiting, diarrhea, constipation, or upset stomach;

• swelling in your hands or feet;

• headache, dizziness, drowsiness;

• loss of appetite, weight loss; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bendamustine: intravenous powder for injection

Hematologic

Hematologic side effects including neutropenia (28%), thrombocytopenia (23%), anemia (19%), leukopenia (18%), lymphopenia (7%), and tumor lysis syndrome have been reported.

Laboratory abnormalities have included decreased lymphocytes (up to 99%), decreased leukocytes (up to 94%). decreased hemoglobin (up to 89%), decreased platelets (up to 86%), and decreased neutrophils (up to 86%).

Tumor lysis syndrome associated with bendamustine treatment has been reported in patients in clinical trials and in postmarketing reports. The onset tends to be within the first treatment cycle of bendamustine and, without intervention, may lead to acute renal failure and death. Preventive measures include maintaining adequate volume status, and close monitoring of blood chemistry, particularly potassium and uric acid levels. Allopurinol has also been used during the beginning of bendamustine therapy. However, there may be an increased risk of severe skin toxicity when bendamustine and allopurinol are administered concomitantly.

Red blood cell transfusions were administered to 20% of patients receiving bendamustine.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 75%), vomiting (up to 40%), diarrhea (up to 37%) constipation (29%), stomatitis (15%), abdominal pain (13%), dyspepsia (11%), gastroesophageal reflux disease (10%), dry mouth (9%), upper abdominal pain (5%), and abdominal distension (5%) have been reported.

General

General side effects including fatigue (up to 57%), pyrexia (up to 34%), chills (up to 14%), peripheral edema (13%), asthenia (up to 11%), and chest pain (6%) have been reported.

Metabolic

Metabolic side effects including anorexia (23%), dehydration (14%), decreased appetite (13%), hypokalemia (9%), and hyperuricemia (7%) have been reported.

Respiratory

Respiratory side effects including cough (up to 22%), dyspnea (16%), upper respiratory tract infection (10%), sinusitis (9%), pneumonia (8%), pharyngolaryngeal pain (8%), nasopharyngitis (7%), wheezing (5%), nasal congestion (5%), and cough (4%) have been reported.

Nervous system

Nervous system side effects including headache (21%), dizziness (14%), and dysgeusia (7%) have been reported.

Dermatologic

Dermatologic side effects including rash (up to 16%) pruritus (up to 6%), dry skin (5%), night sweats (5%), hyperhidrosis (5%), toxic skin reactions, and bullous exanthema have been reported. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) some fatal, have also been reported.

Some skin reactions have occurred when bendamustine was given in combination with other anticancer agents, so the precise relationship to bendamustine is uncertain.

Where skin reactions occur, they may be progressive and increase in severity with further treatment. If skin reactions are severe or progressive, bendamustine should be withheld or discontinued.

Musculoskeletal

Musculoskeletal side effects including back pain (14%), arthralgia (6%), pain in extremity (5%), and bone pain (5%) have been reported.

Psychiatric

Psychiatric side effects including insomnia (13%), anxiety (8%), and depression (6%) have been reported.

Other

Other side effects including herpes zoster (10%), decreased weight (7%), febrile neutropenia (6%), oral candidiasis (6%), infection (6%), and herpes simplex (3%) have been reported.

Renal

Renal side effects including urinary tract infection (10%) have been reported.

Cardiovascular

Cardiovascular side effects including tachycardia (7%) and hypotension (6%) have been reported.

Local

There have been postmarketing reports of bendamustine extravasations resulting in hospitalizations from erythema, marked swelling, and pain. Precautions should be taken to avoid extravasation, including monitoring of the intravenous infusion site for redness, swelling, pain, infection, and necrosis both during and after administration.

Local side effects including infusion site pain (6%), catheter site pain (5%), extravasations, phlebitis, pruritus, irritation, pain, and swelling have been reported.

Immunologic

Immunologic side effects including hypersensitivity (5%) have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.

Oncologic

Oncologic side effects have included pre-malignant and malignant diseases that have been reported in patients who have been treated with bendamustine, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma.

The association between the oncologic side effects and bendamustine therapy has not been determined.

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