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 (computed tomography) scans or MRI (magnetic resonance imaging), may also be done. These tests will tell the doctor how you are responding to treatment with TREANDA. If the tests do not show any trace of CLL cells, you will be said to have a complete response. If the number of CLL cells is lower, you may be said to have a partial response. Sometimes a patient may not respond to treatment.

The Treatment Diary you'll be given may help you keep track of your treatments and blood counts. This may also help your healthcare team know if TREANDA is working for you.

How do I know if TREANDA works in CLL?

In a clinical study, TREANDA was compared to chlorambucil. (Chlorambucil is another drug approved by the Food and Drug Administration to treat CLL.) Both medications were given without any other chemotherapy agents. There were 153 patients who took TREANDA, and 148 patients who took chlorambucil. Patients were 75 years old or younger, and were Binet stage B or C (Rai stages I-IV). Binet stage is another way of classifying how far the disease has progressed. None of the patients had ever been treated for their CLL.

In this clinical study, TREANDA provided a higher overall response rate vs chlorambucil. In fact, 59% of patients responded to TREANDA and 26% of patients responded to chlorambucil.

TREANDA also delayed "disease progression" in some patients, which means that the disease did not get worse for a noticeable period of time. Patients using TREANDA went a median of 18 months without their CLL getting worse versus 6 months with chlorambucil.

This number shows the "median" time of delayed disease progression. "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 pyrexia (fever), nausea, and vomiting
• The most common blood-related side effects (occurring in ≥15% of patients) with TREANDA are reduction of red blood cells, reduction of blood platelets, reduction of neutrophils (white blood cells), reduction of lymphoid cells in the blood, and low counts of leukocytes (white blood cells)
• 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