Dosing and Administration

Clinical Studies

Professional Resources

Resources For Patients

HCP Home | Full Prescribing Information (PDF) | Contact Us | Site Map

As a single agent for B-cell chronic lymphocytic leukemia (B-CLL) - Change Your Thinking: Campath First Line(1)

Print | Text Size:

Professional Resources

This page contains PDF versions of helpful materials on CLL and Campath therapy for your practice. Click on the thumbnail images to download:

CLL Slide Kit, Part 1: Diagnosis, Staging, and Prognosis
This slide kit contains a clinical review of the biology of CLL, how it is diagnosed and staged, response criteria, and prognostic indicators.

Cytomegalovirus (CMV) Management Guidelines
Featured on this front-and-back card are Dr. Susan O'Brien's 2006 updated CMV guidelines, including a management algorithm and recommendations for treatment.

Campath First-line Treatment Brochure
Learn about the phase 3 pivotal first-line trial results of Campath versus chlorambucil for B-CLL. Information presented includes the trial design, progression-free survival and response rate results, safety profile, dosing, and CamCare^™ support services.

Campath Dosing and Administration Guidelines
Review important dosing and administration guidelines to help you treat your Campath patients for the recommended 12 weeks of therapy. Dosing schedule, premedication and prophylaxis, dose modification, and management of adverse events are discussed.

Campath First-line Treatment Card
A brief overview of the efficacy, safety, and dosing of single-agent Campath as first-line therapy for B-CLL is featured.

Full Prescribing Information Brochure
This enlarged version of the Campath full Prescribing Information conveniently highlights information about Campath in the first-line setting.

Campath First-line Slide Presentation
Review the slide presentation of the phase 3 pivotal first-line trial of Campath versus chlorambucil for B-CLL. Detailed information is provided on the study design, treatment regimens, baseline characteristics, and efficacy and safety results.

Bayer HealthCare Pharmaceuticals Medical Information Services is a valuable support resource that can help answer medical questions and provide more information about products marketed by Bayer HealthCare Pharmaceuticals, including Campath.

1-888-84BAYER (1-888-842-2937) Monday through Friday, 9 AM to 5 PM ET

Indications & Usage

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

Important safety information

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.

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.

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.

In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. The following serious, including fatal, infusion reactions have been identified in post-marketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.

Prolonged myelosuppression have been reported in patients receiving Campath. Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections. Assess CD4+ counts after treatment until recovery to ≥ 200 cells/µL. Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia).

Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion.

Routinely monitor patients for CMV infection during Campath treatment and for at least 2 months following completion of treatment. Withhold Campath for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia.

Do not administer live viral vaccines to patients who have recently received Campath.

The most common adverse reactions (≥ 10%) were infusion reactions, cytopenias, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see full Prescribing Information (PDF).