Press Release Prescribing Information
Campath® Alemtuzumab - For Intravenous Use Only
SEARCH
 
I am taking CAMPATH
I Am Considering Campath
I Am a Caregiver
 
Understanding CLL
Causes, Incidence, and Risk Factors of CLL
Diagnosis of CLL
Staging of CLL
Treatment of CLL
Treatment Response of CLL
Follow-Up Care
References
Resources and Tools
CamCareTM Assistance Program
 
   Home  |  Full Prescribing Information (PDF)  |  Contact Us  |  Site Map  
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
Print | Text Size:

Campath Patient Kit

 

References

  1. Dirckx JH, ed. Stedman's Concise Medical Dictionary for the Health Professions. 4th edition. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:557, 579.
  2. Chiorazzi N, Rai KR, Ferrarini M. Chronic lymphocytic leukemia. N Engl J Med. 2005;352:804-815.
  3. O'Brien S, Keating MJ. Chronic lymphoid leukemias. In: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer: Principles and Practice of Oncology. 7th edition. Philadelphia, Pa: Lippincott Williams & Wilkins; 2005:2133-2143.
  4. American Cancer Society. Leukemia—Chronic Lymphocytic. Atlanta, Ga: American Cancer Society; 2006. Available at: http://documents.cancer.org/6893.00/6893.00.pdf. Accessed March 28, 2006.
  5. American Cancer Society. Cancer Facts and Figures 2006. Atlanta, Ga: American Cancer Society; 2006.
  6. SEER Cancer Stat Fact Sheets: Chronic lymphocytic leukemia. Available at: http://seer.cancer.gov/statfacts/html/clyl_print.html. Accessed March 28, 2006.
  7. Rawstron AC, Yuille MR, Fuller J, et al. Inherited predisposition to CLL is detectable as subclinical monoclonal B-lymphocyte expansion. Blood. 2002;100:2289-2291.
  8. Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-4997.
  9. Rai KR, Sawitsky A, Cronkite EP, Chanana AD, Levy RN, Pasternack BS. Clinical staging of chronic lymphocytic leukemia. Blood. 1975;46:219-234.
  10. Kipps TJ. Chronic lymphocytic leukemia and related diseases. In: Beutler E, Lichtman MA, Coller BS, Kipps TJ, eds. Williams Hematology. 5th edition. New York, NY: McGraw-Hill Health Professions Division; 1995:1017-1039.
  11. National Comprehensive Cancer Network. Non-Hodgkin's Lymphoma: Clinical Practice Guidelines in Oncology, Version 2.2006. Available at: http://www.nccn.org/professionals/
    physician_gls/PDF/nhl.pdf. Accessed April 11, 2006.
  12. Rozman C, Montserrat E. Chronic lymphocytic leukemia. N Engl J Med. 1995;333:1052-1057.
  13. Albitar M, Do K-A, Johnson MM, et al. Free circulating soluble CD52 as a tumor marker in chronic lymphocytic leukemia and its implication in therapy with anti-CD52 antibodies. Cancer. 2004;101:999-1008.
  14. Kimby E, Brandt L, Nygren P, Glimelius B, for the SBU-group. A systematic overview of chemotherapy effects in B-cell chronic lymphocytic leukaemia. Acta Oncol. 2001;40:224-230.
  15. FLUDARA® (fludarabine phosphate) [package insert]. Montville, NJ: Bayer HealthCare Pharamceuticals, Inc; 2003.
  16. CAMPATH® (alemtuzumab) [package insert]. Montville, NJ: Bayer HealthCare Pharamceuticals, Inc; 2005.
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).