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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Clinical Studies

Several clinical trails involving alemtuzumab are currently underway. For information, please call 1-888-BERLEX-4 (1-888-237-5394), then press 7.

Clinical trial links

Here are links to websites with the latest information about ongoing clinical trials in CLL and studies using Campath® (alemtuzumab).

CancerTrialsHelp.org
www.cancertrialshelp.org
This is the official website of the Coalition of Cancer Cooperative Groups, a national network of cancer clinical trials specialists. Click on About Clinical Trials or Trial Search for trials sponsored by members of the coalition.

Center Watch
www.centerwatch.com
This extensive trial listing site includes more than 41,000 industry- and government-sponsored clinical studies. Listings can be searched by medical areas or enter CLL as the key word and select a state or region for the trial location.

ClinicalTrials.gov
www.clinicaltrials.gov
This site is a service of the U.S. National Institutes of Health (NIH) that contains over 27,000 clinical studies sponsored by the NIH, other federal agencies, and private industry. Search by entering keywords or to search by disease, location, treatment, or sponsor.

National Cancer Institute: Clinical Trials
www.cancer.gov/clinicaltrials
This is a comprehensive site with information about clinical trials. It contains summaries of newsworthy results of completed trials and timely information on topics such as new treatments and insurance.

TrialsCentral
www.trialscentral.org
While this site provides general information, its main function is as a clinical trials register. The database under Clinical Trials contains an extensive listing of companies and institutions conducting clinical research studies. The Condition section in Clinical Trials presents broad categories, so if you select Cancers, you may need to spend a little time finding the specific information that is appropriate for you. You can also select your state to find links to local clinical trials.

Veritas Medicine
www.veritasmedicine.com
This site is a searchable online resource of ongoing clinical trials. It is possible to register here for notification of new clinical trials that have open enrollment.

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).