Side Effects and Safety

When chemotherapies kill cancer cells, they can also affect healthy blood cells. These healthy cells include red blood cells, platelets, and white blood cells. Some of the most common side effects occur when the number of healthy cells is reduced. Please discuss the possible risks of side effects with your healthcare professional.

Talk to your healthcare professional

Review the information below and discuss any concerns with your healthcare professional.

Allergic reactions: There is the possibility of mild or serious reactions with TREANDA®. Immediately report rash, facial swelling, or difficulty breathing during
or soon after infusion.

Myelosuppression: TREANDA may cause a decrease in white blood cells, platelets, and red blood cells. You will need frequent monitoring of your blood cells. Report shortness of breath, significant fatigue, bleeding, fever, or other signs of infection.

Pregnancy and nursing: TREANDA can cause harm to a fetus. Women should avoid becoming pregnant throughout treatment and for 3 months after TREANDA therapy has stopped. Men receiving TREANDA should use reliable contraception for the same time period. Report pregnancy immediately. Avoid nursing while receiving TREANDA.

Fatigue: TREANDA may cause tiredness. Avoid driving any vehicle or operating any dangerous tools or machinery if you experience this side effect.

Nausea and vomiting: TREANDA may cause nausea and/or vomiting. You should report nausea and vomiting so that treatment for these symptoms may be provided.

Diarrhea: TREANDA may cause diarrhea. You should report diarrhea to your healthcare professional so that treatment may be provided.

Rash: A mild rash or itching may occur during treatment with TREANDA. Immediately report severe or worsening rash or itching.

TREANDA for injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. TREANDA is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

The following serious adverse reactions have been associated with TREANDA: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies, and extravasation. Some of these reactions have been fatal, including myelosuppression, infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol and other medications known to cause SJS/TEN). Patients should be monitored closely for these reactions and treated promptly if any occur. Adverse reactions may require interventions such as decreasing the dose of TREANDA, or withholding or delaying treatment. Myelosuppression is frequently severe and should be expected when treating patients with TREANDA.

TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA.

The most common non-hematologic adverse reactions associated with TREANDA (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

Please see full Prescribing Information.