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What is TREANDA?

TREANDA is a unique chemotherapy that has been shown to kill cells that cause CLL. The exact way in which TREANDA kills cells is still being studied in laboratories.

In a clinical study, TREANDA was compared with another CLL drug named chlorambucil. Both drugs were given without being combined with another drug. There were 153 patients who took TREANDA and 148 patients who took chlorambucil. None of the patients had ever received treatment for CLL before this treatment. TREANDA worked in more than twice as many patients as chlorambucil.

TREANDA also tripled the disease-free time experienced by patients with CLL in the clinical study. Patients who received TREANDA were disease free for a longer period of time (18 months) compared with patients who received chlorambucil (6 months). This means that patients who responded to TREANDA had their response for a longer time than the patients who responded to chlorambucil. This is known as delaying disease progression.

How will I receive TREANDA to treat CLL?

You will get TREANDA either at your doctor's office, the hospital, or at an infusion center. For the treatment of CLL you will be given TREANDA as an intravenous (IV) infusion. This means that TREANDA will be given through a needle in your vein for 30 minutes. TREANDA may be given for up to 6 cycles. Each cycle is made up of 28 days. You will be given TREANDA on Day 1 and Day 2 of each 28-day cycle.

As explained earlier, not all patients are the same, so it may be necessary for your doctor to make changes to the dose of TREANDA to find out what is right for you. Changing the dose or delaying treatment may be necessary if you are experiencing side effects.

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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

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