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Heart Function Service: Heart Transplant Protocols

               Protocol for Administration of Alemtuzumab (Campath®)


               Description:  Alemtuzumab is a recombinant DNA-derived humanized monoclonal antibody directed
               against CD52.  CD52 is an antigen present on the surface of B and T lymphocytes, a majority of
               monocytes, macrophages, NK cells and granulocytes(<5%) and absent on erythrocytes, platelets and
               hematopoietic stem cells. A proportion of bone marrow cells, including some CD34+ cells, express
               variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated
               lysis of lymphocytes.

               Indication: Approved as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
               Also, used in solid organ transplant for induction & rejection (off-label).

               Dose:
               Children: 1mg/kg subcutaneously x 1, max dose: 30mg
               Adult: 30mg subcutaneously x 1

               Administration:
                     Preparation: No dilution needed
                     Premedication:
                          o  Acetaminophen 15 mg/kg (max 650 mg) PO x 1
                          o  Diphenhydramine 1 mg/kg (max 50 mg) IV or PO x 1
                          o  Methylprednisolone, none, intra-operative dose sufficient
                     Administration:  Administer subcutaneously in either buttocks or thighs post-transplantation.
                     Prophylaxis: Antiviral, antibacterial, antimycobacterium and antifungal prophylaxis should be
                       initiated after receiving Alemtuzumab

               Monitoring:
                     Check CBC with differential before transplant, post-transplant, weekly x first month, then
                       monthly x 12 months
                                                                                      3
                                               st
                     Check CD4 weekly for the 1  2 weeks; if CD4 persistently < 50 cells/mm , recheck CD4 every 3
                       month
                     CMV, EBV and BK checked monthly for the first 6 months, then annually
                     If bone marrow suppression occurs, as defined by WBC <3000, Hct<30% and/or platelet counts
                       <75, 000, consider discontinue/decrease mycophenolate, valganciclovir, valacyclovir, PPI and/or
                       bactrim.
               Stability:  Use within 8 hours after dilution. Store diluted Alemtuzumab at room temperature (15-30°C)
               or refrigerated (2-8°C). Protect from light
               Side Effects: Most common adverse reactions (≥ 10%): cytopenias (lymphocyte could be suppressed for
               up to 1 year), infusion reactions, CMV and other infections, nausea, emesis, diarrhea, and insomnia
               Reference:
                   1.  Product Information: CAMPATH(R) IV solution for injection, alemtuzumab IV solution for injection.
                       Genzyme Corp, Cambridge, MA, 2007.
                   2.  Vo AA, Wechsler EA, Wang J, et al. Analysis of subcutaneous(SQ) Alemtuzumab Induction Therapy in
                       Highly Sensitized Patients Desensitized With IVIG and Rituximab. American Journal of Transplantation
                       2008; 8: 144–149.
                   3.  Bartosh SM, Knechtle SJ, Sollinger HW. Campath-1H Use in Pediatric Renal Transplantation. American
                       Journal of Transplantation 2005;5:1569-1573.








               Updated November 9, 2017                                                                    79
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