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As a single agent for B-cell chronic lymphocytic leukemia (B-CLL) - Change Your Thinking: Campath First Line(1)
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Questions to Discuss With Your Doctor

 

How Is CLL Diagnosed?

In the early stages of the disease, there may be no symptoms at all. Many cases of CLL are detected during routine medical examinations of people who show no obvious signs of illness. Usually, the disease is discovered when a routine blood test shows an increase in the white blood cell count. Other patients may be diagnosed after being seen for another condition, such as a chest infection or feeling tired all the time.4 In fact, it is suspected that many cases of CLL remain undetected for many years.

Signs and symptoms

People with CLL find that they4,9-11:

Other less common symptoms are drenching night sweats, unexplained loss of 10% of body weight, and a fever of more than 100°F (38°C) lasting for more than a week. These are the so-called B-symptoms (which have nothing to do with B cells, a type of white blood cell).9,11

In the later stages of the disease, the liver and/or spleen may be enlarged.4

Because the bone marrow is not producing enough of the cells called platelets, the blood does not clot properly, so bruises may occur very easily.10

All of these signs and symptoms are also caused by other more common and less serious conditions. Therefore, if you think that you are suffering from any of these, see your doctor for a professional diagnosis.

Tests

If your doctor suspects that you may have CLL, you will have a number of tests. These will assist the doctor in deciding whether you have CLL and determining how advanced it is. There are many noncancerous conditions that also produce an increase in the number of lymphocytes in the blood and these have to be ruled out.9,12

Blood tests
Bone marrow examination
Cell markers
Medical imaging

Staging and prognosis

Based on your symptoms and the results of your tests, your doctor will stage your disease to find out how far it has progressed.4

Most newly diagnosed patients are in an early, symptom-free stage of CLL and have an average life expectancy of around 10 years or more.10,13 Patients with more advanced disease have a much shorter life expectancy.

Indications & Usage

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

Important safety information
WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS

Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.

Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days.

Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections.

In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. The following serious, including fatal, infusion reactions have been identified in post-marketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.

Prolonged myelosuppression have been reported in patients receiving Campath. Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections. Assess CD4+ counts after treatment until recovery to ≥ 200 cells/µL. Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia).

Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion.

Routinely monitor patients for CMV infection during Campath treatment and for at least 2 months following completion of treatment. Withhold Campath for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia.

Do not administer live viral vaccines to patients who have recently received Campath.

The most common adverse reactions (≥ 10%) were infusion reactions, cytopenias, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see full Prescribing Information (PDF).