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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CLL and Cancer Support Links

Where can patients get more information about CLL and their treatment?

Patients can call CamCare at 1-800-473-5832. Registered nurses certified in oncology are ready to help 24 hours a day, 7 days a week, 365 days a year. They can answer questions on B-CLL and Campath® (alemtuzumab) therapy.

Patients can also find information and support through the following organizations:

General cancer information

American Cancer Society®
1-800-ACS-2345
(1-800-227-2345)
www.cancer.org

Cancer Care, Inc.
1-800-813-HOPE
(1-800-813-4673)
www.cancercare.org

National Cancer Institute®
1-800-4-CANCER
(1-800-422-6237)
www.cancer.gov

Association of Cancer
1-212-226-5525
Online Resources
www.acor.org

Information about CLL

The Leukemia & Lymphoma Society®
1-800-955-4572
www.leukemia-lymphoma.org

Health Talk Interactive
1-206-352-4066
www.healthtalk.com/chroniclymphocyticleukemia/

CLL Topics
www.clltopics.org

Patient and caregiver support groups

Caregiving Online®
www.caregiving.com

Caregiver Network, Inc.
www.caregiver.on.ca

Oncolink®
www.oncolink.upenn.edu

National Family Caregivers Association
1-800-896-3650
www.nfcacares.org

People Living With Cancer (an ASCO website)
www.pluc.org

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).