Press Release Prescribing Information
Campath® Alemtuzumab - For Intravenous Use Only - illuminating possibilites
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As a single agent for B-cell chronic lymphocytic leukemia (B-CLL) - Change Your Thinking: Campath First Line(1)
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Administering and Dosing

How Campath is administered and for how long

Campath is given intravenously (IV)—that is, injected directly into a vein. While the patient is receiving Campath, you can talk, read, or listen to music with him/her. The patient will probably receive Campath at the doctor's office or a hospital clinic, and each treatment will take about 2 hours. However, the first few treatments may take longer because of the body's need to adjust gradually to Campath.

Before treatment with Campath

About 30 minutes before the patient gets Campath, he/she will be given other medications (such as Tylenol® (acetaminophen) or Benadryl® (diphenhydramine), given orally, not IV, often referred to as "premedication") to help reduce side effects. As the caregiver, you should go with the patient for the treatments, as the premedication could make him/her sleepy.

During treatment with Campath

On the first day, the patient will get a low dose (3 mg) of Campath. If he/she is able to tolerate the medication and the side effects are not serious, he/she will get a higher dose (10 mg) the next day. This "dose escalation" will continue until the patient reaches the recommended dose (30 mg). Most patients are able to reach this dose in 3 to 7 days. After that, he/she will get 30 mg of Campath every other day, 3 days a week, for 12 weeks, as the doctor will decide.

During treatment, the patient will also receive anti-infective medications, such as Bactrim DS® (trimethoprim/sulfamethoxazole) and Famvir® (famciclovir) or a similar drug, which he/she will be asked to continue taking at home after therapy has been completed.

Sample Treatment Schedule

Sample Schedule

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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).