Campath® (alemtuzumab) 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 30mg or cumulative doses greater than 90mg per week increase the incidence of pancytopenia.
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| 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.
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| 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. |
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Important Safety Information
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.
For details about Campath, including full Prescribing Information, visit www.campath.com.
For information on a Dear Healthcare Professional Communication on Investigator Sponsored Trial Data (CALGB10101) that was issued in the European Union on February 2008, visit http://www.campath.com/hcp/index.jsp.
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CONTACT INFORMATION: |
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Genzyme Oncology
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