About Campath® (alemtuzumab)
What is a monoclonal antibody?
Antibodies are a natural part of your immune system. The body makes antibodies to attack certain foreign substances that enter the body and threaten its health. The antibody attaches itself to the antigen (foreign substance) and marks it for destruction by your immune system.
A monoclonal antibody (MAb) is an antibody that has been created in a laboratory. MAbs are designed to target only certain specific cells for destruction. Unlike chemotherapy, MAbs attach themselves to specific antigens found on the surface of certain cells.
Like a natural antibody, this lab-created antibody binds to a specific antigen—like a key sliding inside a lock-and destroys it.
What is Campath and how does it destroy cancer cells?
Campath is the first and only monoclonal antibody approved by the Food and Drug Administration (FDA) for the treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL) who have already been treated with alkylating agents and who have failed fludarabine therapy.
Campath works by targeting a certain antigen, CD52, that is found on the surface of B cells, T cells, and other cells, too. When Campath binds to this antigen, it activates your immune system to destroy these targeted cells.
Is there anyone who should not take Campath?
Campath is not appropriate for all patients, including those patients with active systemic infections or certain deficiencies of the immune system (such as positive HIV status), or patients who are highly sensitive or allergic to Campath or its components.
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).
