How do I know if TREANDA is working for me?

During your treatment, your healthcare team will do a physical exam and will take blood samples for testing. Some imaging studies (like CT or PET [positron emission tomography] scans) may also be done. These tests will tell the doctor how your TREANDA treatment is working. If the tests do not show any trace of the cancer-causing non-Hodgkin’s lymphoma (NHL) cells, it means you have had a complete response. If the cancer-causing NHL cells are reduced, it means you have had a partial response. Sometimes, a patient may not respond to treatment.

The Treatment Diary can help you keep track of your infusions and blood counts. This can also help your healthcare team know whether TREANDA is working for you.

How do I know if TREANDA works in NHL?

TREANDA showed a high overall response rate when used alone in a clinical study. The overall response was 74% for patients whose disease spread or progressed during or within 6 months after treatment with rituximab or a rituximab-containing regimen.

In a clinical study, TREANDA was not compared to or combined with additional treatments. A total of 100 patients received TREANDA. The study included patients who were diagnosed with a form of indolent B-cell NHL. They had also already been treated with rituximab or a combination of treatments that included rituximab and their disease progressed during treatment or within 6 months of stopping it.

There was a lasting response in patients receiving TREANDA. In this study, the median duration of response was 9.2 months for patients taking TREANDA.

"Median" is the number where half of the patients experienced higher duration of response and half experienced lower duration of response.

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Indications

TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

TREANDA is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Important Safety Information

• The most common non-blood-related side effects (occurring in ≥15% of patients) with TREANDA are nausea, fatigue, vomiting, diarrhea, pyrexia (fever), constipation, anorexia (loss of appetite), cough, headache, weight decreased, dyspnea (difficulty breathing), rash, and stomatitis (inflammation of the mouth)
• The most common blood-related side effects (occurring in ≥15% of patients) with TREANDA are reduction of lymphoid cells in the blood, low counts of leukocytes (white blood cells), reduction of red blood cells, reduction of neutrophils (white blood cells) and reduction of blood platelets
• Allergic Reactions: There is a possibility of mild or serious allergic reactions with TREANDA. Immediately report rash, facial swelling, or difficulty breathing during or soon after infusion because these symptoms may become severe or even life-threatening
• 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 because these symptoms may become severe or even life-threatening
• Pregnancy and Nursing: TREANDA can cause fetal harm. 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 to your doctor so that you can get treatment for these symptoms
• Diarrhea: TREANDA may cause diarrhea. You should report diarrhea to your doctor so that it can be treated
• Rash: A mild rash or itching may occur during treatment with TREANDA. Immediately report severe or worsening rash or itching to your doctor
• Some side effects may lead to the dose of TREANDA being lowered, stopped, or delayed
• You should not take TREANDA if you have a known allergy to bendamustine or mannitol