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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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Questions to Discuss With Your Doctor

 

Medical Imaging

Your doctor may ask for tests to be done in the radiology department to see if any lymph nodes inside your body are swollen and if your liver or spleen are enlarged.5,9

Ultrasound

An ultrasound test is painless and gives a good view of the inside of your abdomen. You will be asked to lie on your back. Your abdomen will be exposed and some clear gel will be spread on it. The technician will then move a metal probe about the size of a large pen backward and forward across your skin. This transmits very high-frequency sound waves into your abdomen, which then bounce back and are picked up and used to form a picture of your internal organs.5

Computed tomography (CT)

In a CT scan, x-rays are beamed from different angles all around you to build a 3-dimensional picture of the organs inside your body. The examination may include the injection of a contrast agent into your bloodstream to improve the visibility of some of your organs to x-rays. The CT scan is painless (except for the prick of the needle for the injection) and lasts about 15 minutes.5

You will lie on the examination table while the CT machine—which is shaped like a large, upright doughnut—moves over you, making a whirring noise as it rotates to different positions to scan your body. You will have to lie still throughout the entire exam, which usually lasts about 15 minutes.5

If a contrast agent is used, the radiographer will place a needle into your vein and inject the agent into your bloodstream. The contrast agent often produces a warm feeling as it goes into your vein, but otherwise it should be painless.5

Magnetic resonance imaging (MRI)

An MRI scan can also take a 3-dimensional picture of your internal organs, but does so without x-rays. Instead, it uses a very strong magnet and high-frequency radio waves. The experience of an MRI scan for the patient is very similar to that of a CT scan, but is a lot noisier and lasts longer—up to 1 hour. It makes loud thumping noises, but you may be given headphones or earplugs to block out the sound. A small minority of patients experience claustrophobia when they are in the "tube" of an MRI device, which may feel confining.5

All of these tests will help the doctor judge what treatment is needed, if any.

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).