Frequently asked questions about indolent B-cell NHL that has progressed and TREANDA

Click on the questions below to find out more about indolent B-cell non-Hodgkin's lymphoma that has progressed and treatment with TREANDA®.

What is NHL?

Non-Hodgkin's lymphoma (NHL) is not a single disease but a general term used
for a diverse group of up to 30 closely related cancers of the lymphatic system. Doctors categorize the many different types of NHL by the kind of cells (also called lymphocytes) that are abnormal, how fast they grow, and how they affect the body. In general, B-cell lymphomas start from abnormal B-cells, and T-cell lymphomas start from abnormal T-cells.

Non-Hodgkin's lymphoma can begin in any part of the lymphatic system, including the lymph nodes, special lymph organs such as the spleen, the bone marrow that makes lymphocytes, or in the lymph tissue of organs such as the stomach or intestines. Because lymphocytes are able to circulate to virtually every part of the body through the lymphatic system, NHL commonly spreads to different parts of the body. In fact, NHL is often present in more than one part of the body by the time it is diagnosed.

What are the symptoms of indolent B-cell NHL?

Indolent B-cell NHL is often asymptomatic (there are no symptoms). In this case, it may be discovered during a routine checkup. For example, a blood test may show something out of the ordinary. In other instances, there could be physical signs and symptoms that last for an unusually long time.

Common symptoms of indolent NHL may include:

  • Enlarged lymph nodes/swollen glands
  • Fevers and/or soaking night sweats
  • Chills
  • Itching
  • Unexplained weight loss
  • Unexplained fatigue

How is indolent B-cell NHL diagnosed?

Tests commonly used to diagnose indolent B-cell NHL include:

  • Physical exam—to check for swollen glands (lymph nodes)
  • Biopsy—to confirm whether abnormal cells are in lymph nodes or other lymph tissues. A biopsy is the only way to positively diagnose NHL, to identify chromosomal abnormalities, and to find out if it is a B-cell or T-cell lymphoma (see biopsy)
  • Blood tests—to assess white blood cell counts and a substance called lactate dehydrogenase (LDH), which can become high from NHL
  • Imaging tests—such as CT scan, MRI, and PET scan, to check for swollen lymph nodes or other signs of NHL

What are the stages of indolent B-cell NHL?

Based on the results of your tests, your doctor will classify indolent NHL by one of the following stages:

In addition, your doctor may use the letters A, B, or E to further classify the stage of NHL.

  • A means no symptoms are present (e.g., fever, chills, night sweats, itching, and weight loss)
  • B means symptoms such as fever, chills, night sweats, itching, and weight loss are present
  • E means involvement of a part of your body other than the lymph nodes

What is the goal of treatment?

The goal of any treatment for indolent B-cell NHL is to reduce or eliminate the presence of indolent B-cell NHL cells in the blood and bone marrow.

What is TREANDA?

TREANDA is a chemotherapy agent with alkylating properties, which means it can kill indolent B-cell NHL cells. It has a unique design that combines two kinds of chemical structures. TREANDA can kill cancer cells by several biologic pathways. The way TREANDA works has been studied in the lab, but how it specifically works is still being investigated.

How is TREANDA given?

TREANDA is usually provided in an outpatient setting and is given through a needle that is put into your vein. This is called intravenous infusion (IV). The infusion lasts for 60 minutes and is given on Days 1 and 2 of each 21-day treatment cycle. TREANDA may be given for up to 8 cycles.

What are the results of treatment with TREANDA?

After treatment with TREANDA, some patients may have no signs of indolent B-cell non-Hodgkin's lymphoma in their blood. This is called a complete response. Other patients may have a reduced number of indolent B-cell NHL cells or reduced symptoms. This is called a partial response. Some patients may have no response to this treatment. The combined number of patients with complete response and partial response is known as the overall response rate.

TREANDA provided a high overall response rate when used as a single agent in a clinical study. The overall response was 74% for patients whose disease progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.*

OVERALL RESPONSE TO TREATMENT*

In addition, TREANDA maintained duration of response, which is the amount of time the response to treatment lasts. In this study, the median duration of response was 9.2 months for patients taking TREANDA.*

DURATION OF RESPONSE*

*In a clinical study, TREANDA was examined alone (not combined with additional therapies). In total, 100 patients took TREANDA. The study included patients who were diagnosed with a form of indolent B-cell NHL and who had received prior treatment with rituximab or a rituximab-containing regimen and whose disease progressed during or within 6 months of treatment.

Does TREANDA have any side effects?

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.

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.

Click here to find out more about talking to your healthcare professional about side effects.

How will my healthcare professional monitor me during treatment?

Your healthcare professional will ask you to have blood drawn to monitor therapy. You may have your dose adjusted or your medications changed based upon the results of this testing. These blood tests will identify if you have low red blood cells, low white blood cells, and/or low platelets.

  • Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath
  • Low white blood cells may give you a greater chance for infection. If you have a fever or other signs of infection, such as chills and coughing, call your doctor right away
  • Low platelets give you a greater chance for bleeding. Call your doctor if you experience any unusual bleeding

You can participate in the course of your treatment by recording your blood counts and making notes about any side effects that may occur in your Treatment Diary. This will give you a record that you can easily share with your healthcare team. Together you can plan ways to manage your treatment and enhance your
well-being.

How do I know if TREANDA is working?

While you are taking TREANDA, your healthcare team will want you to have physical exams, imaging tests (such as CT or PET scans), and lab tests to measure your progress. They will know whether TREANDA is working based on the reduced presence of indolent B-cell NHL cells shown in these tests.

How can I take good care of myself during treatment with TREANDA?

During treatment with TREANDA, it is important to avoid infections, manage fatigue, and eat well.

Tips that may help to avoid infections

  • Talk to your healthcare professional about flu shots for you and your family prior to treatment
  • Call your healthcare professional at the first sign or symptom of infection
  • Use a thermometer if you think you have a fever, and call your healthcare professional if you do
  • Talk to your healthcare professional about how to avoid any immunization with live viral vaccines, such as a flu nasal mist
  • Wash your hands often
  • Keep your body clean, especially your feet, groin, and armpits
  • Avoid people with coughs, colds, or other infections
  • Avoid large crowds
  • Clean cuts or scrapes right away with soap and warm water
  • Use an electric shaver instead of a razor, and don't share it
  • Avoid having manicures, pedicures, false nails, and nail tips
  • Wash fruits and vegetables thoroughly
  • Avoid unpasteurized milk, cheeses, or yogurt
  • Make sure meat, poultry, fish, and eggs are thoroughly cooked
  • Thaw meat in the refrigerator
  • Avoid gardening

Tips that may help to manage fatigue

  • Get enough rest and sleep, but remember:
    • Too much rest can make you feel weaker
    • Try short naps (1 hour) instead of long ones
  • Stay as active as possible
    • Exercise regularly, for example, by walking several times a week
    • Talk to your healthcare professional before starting an exercise program
    • Do gentle stretching exercises and isometrics
  • Manage your energy levels
    • Schedule activities when you have the most energy, and rest between them
    • At home or work, take on only what you can manage; let others help
  • Stay positive
    • Picture yourself doing something you love
    • Say to yourself, “I can create the energy I need”
    • Learn relaxation techniques to slow your heart rate and calm your mind

Practice good nutrition
Good nutrition can help maintain your weight and fight infection. Your diet should include quality protein (fish, low-fat meat, eggs, and tofu). You should also eat more foods with iron, such as meats, leafy greens, and iron-fortified grains and cereals.

Talk to your healthcare professional about speaking to a dietitian or nutritionist about your diet.

Take an active role in your treatment
You can participate in the course of your treatment by recording your blood counts and making notes about any side effects that may occur in your Treatment Diary. This will give you a record that you can easily share with your healthcare team. Together you can plan ways to manage your treatment and enhance your
well-being.

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.