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 the Doctor

Questions for Caregivers of Patients With Refractory CLL

  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?
    3. 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. What treatments are available for refractory CLL (CLL that does not respond to therapy)?
  6. Since he/she has not responded to other therapies, is he/she now a candidate for Campath? Is there any reason why Campath may not be right for him/her?
  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 each treatment/dose? How often will he/she receive the treatments? How long will he/she have to stay on treatment?
  10. Will he/she receive Campath in the hospital or as an outpatient?
  11. Will I need to drive him/her 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 he/she could participate in?
  15. Will he/she get different treatment options in a clinical trial? Is it possible that he/she would receive a placebo?
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).