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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 for Your Doctor

Questions for patients who are considering Campath

  1. What are the prognostic markers of CLL?
  2. I have heard/read about fluorescence in situ hybridization (FISH) testing being used in patients with CLL. What is a FISH test? How are the results used? Have I had this test and, if so, what were the results?
  3. Are there any additional tests that we should consider at this time to determine my prognosis and/or rule out any treatment options?
  4. Based on my test results, am I considered a high-risk patient?
  5. Is there any reason why Campath may not be right for me?
  6. What is a monoclonal antibody and how is it different from other CLL therapies? Is it true that monoclonal antibodies do not cause hair loss?
  7. How effective is Campath?
  8. How long will it take to give me each treatment/dose? How often will I receive treatments? How long will I have to stay on treatment?
  9. Will I receive the treatment in the hospital or as an outpatient?
  10. Will I be able to drive myself to treatment?
  11. What are the side effects of Campath?
  12. Are there any clinical trials of Campath that I could participate in?
  13. What are the advantages and disadvantages of taking part in a clinical trial?

Questions for patients who are receiving Campath

  1. During my therapy, how do I know if Campath is working?
  2. What tests are commonly used to assess the effectiveness of Campath during or after treatment?
  3. I have read that some treatments may leave a few cancer cells behind and these cells may lead to a relapse. Are there tests that look for these few cells?
  4. What should I do if I have a fever? When should I seek medical attention?
  5. What are the symptoms of infection? What should I do if I think I have an infection? When should I seek medical attention?
  6. Should I be concerned if I have a sore that just won't heal?
  7. Should I be concerned about feeling dizzy?
  8. What should I do about nausea and/or vomiting?
  9. Should I be concerned that my gums bleed when I brush my teeth or if I have frequent nosebleeds and/or bruise easily?

Questions for patient caregivers about Campath

  1. What are the prognostic markers of CLL?
  2. I have heard/read about FISH testing being used in patients with CLL. What does a FISH test look for? How are the results used? Has this test been done and, if so, what were the results?
  3. Are there any additional tests that we should consider at this time to determine his/her prognosis and/or rule out any treatment options?
  4. Based on the test results, is he/she considered a high-risk patient?
  5. Is there any reason why Campath may not be right for him/her?
  6. What is a monoclonal antibody and how is it different from other CLL therapies? Is it true that monoclonal antibodies do not cause hair loss?
  7. How effective is Campath?
  8. How long will it take to give each treatment/dose? How often will he/she receive the treatments? How long will he/she have to stay on treatment?
  9. Will he/she receive Campath in the hospital or as an outpatient?
  10. Will I need to drive him/her to treatment?
  11. What are the side effects of Campath?
  12. Are there any clinical trials of Campath that he/she could participate in?
  13. What are the advantages and disadvantages of taking part in a clinical trial?

Questions for patient caregivers during Campath therapy

  1. How do we know if Campath is working?
  2. What tests are commonly used to assess the effectiveness of Campath during or after treatment?
  3. I have read that some treatments may leave a few cancer cells behind and these cells may lead to a relapse. Are there tests that look for these few cells?
  4. What should I do if he/she has a fever? When should I seek medical attention?
  5. What are the symptoms of infection? What should I do if I think he/she has an infection? When should I seek medical attention?
  6. Should I be concerned if he/she has a sore that just won't heal?
  7. Should I be concerned if he/she is feeling dizzy?
  8. What should I do if he/she has any nausea and/or vomiting?
  9. Should I be concerned that his/her gums bleed when he/she brushes his/her teeth or if he/she has frequent nosebleeds and/or bruises easily?
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).