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(alemtuzumab) Injection for Intravenous use
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 (alemtuzumab) . Single doses of Campath (alemtuzumab) greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see WARNINGS AND PRECAUTIONS].
Infusion Reactions: Campath (alemtuzumab) administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath (alemtuzumab) for Grade 3 or 4 infusion reactions. Gradually escalate Campath (alemtuzumab) to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath (alemtuzumab) . Administer prophylaxis against Pneumocystis jirovecipneumonia (PCP) and herpes virus infections [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Campath (alemtuzumab) is a recombinant DNA-derived humanized monoclonal antibody (Campath (alemtuzumab) -IH) directed against the 21-28 kD cell surface glycoprotein, CD52. Campath (alemtuzumab) -1H is an IgGl kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath (alemtuzumab) -1G). The Campath (alemtuzumab) -1H antibody has an approximate molecular weight of 150 kD. Campath (alemtuzumab) is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product.
Campath (alemtuzumab) is a sterile, clear, colorless, isotonic solution (pH 6.8-7.4) for injection. Each single use vial of Campath contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added.
What are the possible side effects of alemtuzumab (Campath)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some people receiving a alemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, hot or cold, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.
Call your doctor at once if you have any of these serious side effects:
- pale skin, easy...
What are the precautions when taking alemtuzumab (Campath)?
Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any current infections, immune system problems (e.g., HIV).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems, low blood pressure.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness...
Last reviewed on RxList: 10/16/2007
This monograph has been modified to include the generic and brand name in many instances.
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