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ARZERRA is a prescription medicine called a monoclonal antibody. It is approved for:
Leukemia is a type of cancer that starts in the bone marrow from white blood cells called lymphocytes. CLL is a chronic disease whereby leukemia cells accumulate slowly over time and may spread from the bone marrow to the blood and other parts of the body (lymph nodes, spleen, and liver).
Symptoms and Diagnosis
Some patients do not have any symptoms when they are initially diagnosed with CLL, but the following are some symptoms that may indicate CLL:
After you have discussed your signs and symptoms, your doctor will want to take a complete medical history and perform a physical exam, with special attention to your lymph nodes and other parts of your body that may be affected. In order to confirm the diagnosis of CLL, you may be prescribed the following tests:
ARZERRA has shown to be an effective treatment option for a variety of patients with CLL:
For adults with CLL who have not yet been treated, ARZERRA has shown to be an effective treatment option. In one clinical trial, previously untreated patients who took ARZERRA plus chlorambucil, a type of chemotherapy, were compared with patients who only took chlorambucil. The results from this trial showed that:
For patients with relapsed CLL, ARZERRA has been shown to be an effective treatment option. In one clinical trial, patients who took ARZERRA plus two chemotherapy drugs, called fludarabine and cyclophosphamide (FC), were compared with patients who only took FC. The results from this trial showed that:
For patients with CLL that has responded to treatment, either partially or completely, after having 2 or more different types of treatment, ARZERRA has shown be an effective form of follow-up treatment. In one clinical trial, patients who took ARZERRA alone as follow-up treatment were compared with those who had no follow-up treatment. The results from this trial showed that:
For patients with CLL who have stopped responding to treatment with a chemotherapy drug called fludarabine and another treatment called alemtuzumab, ARZERRA has shown be an effective treatment option. In one clinical trial, patients who stopped responding to fludarabine and alemtuzumab were treated with ARZERRA alone. The results from this trial showed that:
How ARZERRA is given
ARZERRA is given by intravenous (IV) infusion; that is, through a needle placed in a vein in your arm. Before the treatment, you will be given 3 medicines to help decrease the chance of a possible reaction to the infusion. These medicines are a pain reliever, an antihistamine to reduce allergic reactions, and a steroid to reduce swelling and other symptoms of inflammation. Your health care provider will tell you where you will receive the treatment—for example, a hospital, clinic, or treatment facility.
How long is each infusion of ARZERRA?
Your first infusion of ARZERRA may last 5 hours or longer. The rest of your infusions may take 4 to 4.5 hours. Your health care provider will watch you carefully to see how your body reacts to ARZERRA. That will help him or her know how slowly you should receive your infusion. How long your entire treatment visit may take will depend on how your body reacts to the infusion.
Treatment with ARZERRA is scheduled as follows, based on your condition:
Your treatment will be scheduled in 28-day cycles. You will receive 2 infusions during the first cycle (300 mg on Day 1 and 1000 mg on Day 8). On Day 1 of the following cycles, you will receive a 1000-mg infusion for at least 3 cycles, until best response, or as many as 12 cycles. Your doctor will decide the number of treatment cycles you’ll receive, depending on how your CLL responds to the treatment.
Your treatment will be scheduled in 28-day cycles. You will receive 2 infusions during the first cycle (300 mg on Day 1 and 1000 mg on Day 8). On Day 1 of the following cycles, you will receive a 1000-mg infusion for as many as 6 cycles. Your doctor will decide the number of treatment cycles you’ll receive, depending on how your CLL responds to the treatment.
You will receive 300 mg on Day 1 and 1000 mg on Day 8. You will then receive 1000 mg 7 weeks later and every 8 weeks for a maximum of 2 years. Your doctor will decide the number of treatment cycles you’ll receive, depending on how your CLL responds to the treatment.
You will receive 300 mg on Day 1, then 1 week later, you will receive 2000 mg weekly for 7 doses. Four weeks later, you will receive 2000 mg every 4 weeks for 4 doses.
Treatment with ARZERRA may cause a side effect called an infusion reaction, which may be serious and may even lead to death in some people. Your doctor or nurse will stop your treatment so the infusion reaction can be treated. If you experience severe allergic reactions (anaphylaxis), your infusion will be stopped and you will not continue treatment with ARZERRA. If a reaction occurs, it is most likely to happen with the first 2 infusions and less likely with later infusions.
Signs and symptoms of infusion reactions may include:
Tell your health care provider right away if you have any of the following serious side effects during or after treatment:
Use of ARZERRA may cause:
These are not all of the possible side effects of ARZERRA. Tell your health care provider about any side effects you experience.
For more information about ARZERRA, speak to your health care provider.
In addition, click here to download the "What You Need to Know About ARZERRA" PDF booklet.
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