Press Release Prescribing Information
Campath® Alemtuzumab - For Intravenous Use Only
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As a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) - See Things in a Whole New Light: Campath First Line - Campath® Alemtuzumab For Intravenous Use Only
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Questions For Your Doctor

Questions for Patients With Refractory CLL Who Are Considering 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 like? 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 my prognosis and/or rule out any treatment options?
  4. Based on my test results, am I considered a high-risk patient?
  5. What treatments are available for refractory CLL (CLL that does not respond to therapy)?
  6. Since I have not responded to my other therapies, am I now a candidate for Campath? Is there any reason why Campath may not be right for me?
  7. 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?
  8. How effective is Campath?
  9. 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?
  10. Will I receive the treatment in the hospital or as an outpatient?
  11. Will I be able to drive myself to treatment?
  12. What are the side effects of Campath?
  13. What are the advantages and disadvantages of taking part in a clinical trial?
  14. Are there any clinical trials of Campath that I could participate in?
  15. Will I get different treatment options in a clinical trial? Is it possible that I would receive a placebo?
  16. During my therapy, how do I know if Campath is working?
  17. What tests are commonly used to assess the effectiveness of Campath during or after treatment?
  18. 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?
  19. What should I do if I have a fever? When should I seek medical attention?
  20. What are the symptoms of infection? What should I do if I think I have an infection? When should I seek medical attention?
  21. Should I be concerned if I have a sore that just won't heal?
  22. Should I be concerned about feeling dizzy?
  23. What should I do about nausea and/or vomiting?
  24. Should I be concerned that my gums bleed when I brush my teeth or if I have frequent nosebleeds and/or bruise easily?
Indication and Important Safety Information

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

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 [see WARNINGS AND PRECAUTIONS (5.1)].

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 [see DOSAGE AND ADMINISTRATION (2) and WARNINGS AND PRECAUTIONS (5.2)].

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 [see DOSAGE AND ADMINISTRATION (2.2) and WARNINGS AND PRECAUTIONS (5.3)].

The most commonly reported adverse reactions are infusion reactions fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings and Precautions," and "Adverse Reactions" sections of full Prescribing Information.

Please see Full Prescribing Information (PDF).