break day [250/mm:<250/mm 3 and/or platelets 25,000/mm 3 Temporarily discontinue therapy. 1 When ANC 500/mm 3 and platelets 50,000/mm 3 , 1 resume therapy at 10 mg 3 times weekly; 5 higher dosages not recommended 1 5 If 7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg daily and then to 30 mg 3 times weekly as tolerated. 1 For third occurrence of ANC> <250/mm 3 and/or platelets 25,000/mm 3 Discontinue alemtuzumab permanently 1 For first occurrence of a decrease of ANC and/or platelets by 50% from baseline value in patients initiating therapy with a baseline ANC 250/mm 3 and/or baseline platelets 25,000/mm 3 Temporarily discontinue therapy. 1 When ANC and/or platelets return to baseline values, resume therapy at maintenance dosage (i.e., 30 mg 3 times weekly) 1 5 If 7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg daily and then to 30 mg 3 times weekly as tolerated 1 For second occurrence of a decrease of ANC and/or platelets by 50% from baseline value in patients initiating therapy with ANC of 250/mm 3 and/or platelets 25,000/mm 3 Temporarily discontinue therapy. 1 When ANC and/or platelets return to baseline values, resume therapy at 10 mg 3 times weekly 1 If 7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg 3 times weekly as tolerated 1 For third occurrence of a decrease of ANC and/or platelets by 50% from baseline value in patients initiating therapy with ANC> <250/mm 3 and/or platelets 25,000/mm 3 Discontinue alemtuzumab permanently 1 Infusion Reactions Withhold therapy in patients experiencing grade 3 or 4 infusion reactions. 1 Infectious Complications If serious infection occurs, temporarily discontinue therapy; may reinitiate therapy following resolution of infection. 1 Withhold therapy during antiviral therapy for CMV infection or confirmed CMV viremia (defined as positive for CMV according to PCR in 2 consecutive samples obtained 1 week apart) and initiate anti-infective therapy (ganciclovir or equivalent). 1 RRMS IV Dosage regimen consists of 2 treatment courses: Initial treatment course of 12 mg daily for 5 consecutive days (total dose of 60 mg), followed 12 months later by a second treatment course of 12 mg daily for 3 consecutive days (total dose of 36 mg). a Prescribing Limits Adults B-CLL IV Maximum 30 mg (as single dose) or 90 mg (as cumulative weekly dose); maximum 12 weeks total duration of therapy, including initial dosage and dosage escalation. 1 (See Boxed Warning and see Hematologic Effects under Cautions.) Special Populations No special population dosage recommendations at this time. 1 a Cautions for Campath Contraindications Campath : None. 1 Lemtrada : HIV infection. a Warnings/Precautions Warnings Hematologic Effects Risk of severe (sometimes fatal) cytopenias, including autoimmune anemia, thrombocytopenia, neutropenia, pancytopenia, and prolonged myelosuppression. 1 5 a (See Boxed Warning.) Hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia have occurred in patients receiving recommended dosages for B-CLL. 1 Increased incidence of pancytopenia with higher than recommended dosages (i.e., single doses> 30 mg or cumulative weekly doses >90 mg). 1 Severe, sometimes fatal, ITP reported in patients with RRMS. a In some cases, diagnosed more than 3 years after discontinuance of alemtuzumab. a Manifestations include easy bruising, petechiae, spontaneous mucocutaneous bleeding (e.g., epistaxis, hemoptysis), and heavier than normal or irregular menstrual bleeding. a If ITP suspected, obtain CBC immediately; if confirmed, promptly initiate appropriate treatment. a Hemolytic anemia also reported in patients with RRMS. a Manifestations include weakness, chest pain, jaundice, dark urine, and tachycardia. a In patients with RRMS, obtain CBC with differential prior to initiation of therapy and monthly thereafter for at least 48 months after completion of therapy. a (See Therapy Monitoring under Cautions.) If a cytopenia is confirmed, promptly initiate appropriate treatment. a In patients with B-CLL, withhold therapy if severe cytopenia (except lymphopenia) occurs. 1 (See Dosage under Dosage and Administration.) Discontinue therapy permanently in patients who develop autoimmune hematologic toxicity (i.e., autoimmune anemia or thrombocytopenia) or recurrent or persistent severe cytopenias (except lymphopenia). 1 Safety of reinitiating alemtuzumab in patients with autoimmune cytopenia or bone marrow aplasia not established. 1 Glomerular Nephropathy Autoimmune renal conditions, such as membranous glomerulonephritis and anti-glomerular basement membrane disease, reported in patients receiving alemtuzumab for treatment of RRMS. a (See Boxed Warning.) In some cases, occurred up to 40 months after discontinuance of the drug. a Anti-glomerular basement membrane disease can result in end-stage renal disease requiring dialysis or transplantation. a Clinical manifestations of nephropathy may include elevated S cr , hematuria, proteinuria, and alveolar hemoptysis. a In patients with RRMS, perform S cr and urinalysis with cell counts prior to initiation of therapy and monthly thereafter for at least 48 months after completion of therapy. a (See Therapy Monitoring under Cautions.) If clinically important changes in S cr , unexplained hematuria, or proteinuria occur, further evaluate for possible nephropathy. a Thyroid Disorders Autoimmune thyroid disorders (e.g., Graves' disease, hyperthyroidism, hypothyroidism) reported in approximately 34% of alemtuzumab-treated patients in MS clinical studies. a In some cases, delayed onset (more than 7 years after initiation of therapy) observed. a In patients with RRMS, perform thyroid function tests prior to initiation of therapy and every 3 months thereafter for at least 48 months after completion of therapy. a (See Therapy Monitoring under Cautions.) Use in patients with preexisting thyroid disorders only if potential benefits outweigh potential risks. a Infusion Reactions Risk of serious, sometimes fatal, infusion reactions, including anaphylaxis, angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia, atrial fibrillation, transient neurologic symptoms, hypertension, headache, pyrexia, and rash. 1 a (See Boxed Warning.) Other possible manifestations may include nausea, vomiting, rash, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnea, pulmonary infiltrates, dysgeusia, dyspepsia, dizziness, rigors, fever, or pain. 1 a In some cases, infusion reactions occurred more than 24 hours after the drug was administered. a Administer appropriate premedications (e.g., corticosteroids, antihistamines, antipyretics). 1 a In patients with B-CLL, monitor closely for infusion-related reactions during and shortly after infusion; withhold therapy if a grade 3 or 4 infusion reaction occurs. 1 Initiate medical management (e.g., glucocorticoids, epinephrine, meperidine) as clinically indicated. 1 In patients with RRMS, administer only in a setting with appropriate equipment and personnel to manage serious infusion reactions, including anaphylaxis. a Monitor for infusion reactions during and for at least 2 hours after each infusion. a (See Advice to Patients.) Acute systemic injection-related reactions, including fever and chills/rigors, also reported with sub-Q injection of alemtuzumab, but appear to be more common with IV infusion. 34 35 36 Malignancy Malignancies, including thyroid cancer, melanoma, lymphoproliferative disorders, and lymphoma (e.g., mucosa-associated lymphoid tissue [MALT] lymphoma, Castleman's disease, fatal non-Epstein-Barr virus-associated Burkitt lymphoma, Epstein-Barr virus-associated lymphoproliferative disorders) have occurred. a (See Boxed Warning.) Caution advised when initiating therapy in patients with history of or ongoing malignancy. a Monitor for symptoms of thyroid cancer and perform dermatologic evaluations. a (See Advice to Patients.) Infectious Complications Risk of serious (sometimes fatal) opportunistic bacterial, viral, fungal, or protozoan infections resulting from severe and profound lymphopenia. 1 a Reported infections have included herpes infection, CMV infection, cervical human papillomavirus (HPV) infection, tuberculosis, and listeria meningitis. 1 a In patients with B-CLL, administer prophylactic anti-infectives against Pneumocystis jiroveci (formerly Pneumocystis carinii ) and herpes virus infections during alemtuzumab therapy and for at least 2 months after the last dose is administered. 1 3 4 (See Anti-infective Prophylaxis under Dosage and Administration.) In patients with RRMS, administer antiviral prophylaxis for herpes infection during and for at least 2 months after a course of alemtuzumab. a (See Anti-infective Prophylaxis under Dosage and Administration.) Monitor patients closely for CMV infection during and for at least 2 months following completion of therapy. 1 Screen for HPV annually in women. a Screen and treat (if necessary) patients for tuberculosis prior to alemtuzumab therapy. a Avoid or adequately heat foods that are potential sources of Listeria monocytogenes . a Although no data available regarding specific risk with alemtuzumab, potential exists for reactivation of viral hepatitis; consider screening patients at high risk of HBV or HCV infection prior to initiation of alemtuzumab therapy and use caution in those identified as carriers of the viruses. a In patients with active infection, consider delay in alemtuzumab therapy until infection is controlled. a If serious infection occurs, temporarily withhold therapy until infection resolves. 1 Other Warnings/Precautions Therapy Monitoring In patients with B-CLL, monitor CBCs and platelet counts weekly during therapy; 1 more frequent monitoring may be required in patients with worsening anemia, neutropenia, or thrombocytopenia. 1 Following completion of alemtuzumab therapy, monitor CD4 + T-cell counts until levels return to 200/mm 3 . 1 (See Boxed Warning.) In patients with RRMS, perform tests for CBCs with differential, S cr , and urinalysis with cell counts prior to initiation of therapy and monthly thereafter for at least 48 months after the last dose is administered. a After 48 months, perform such testing based on clinical findings suggestive of possible adverse effects of the drug. a (See Boxed Warning.) In patients with RRMS, obtain thyroid function tests (e.g., TSH concentrations) prior to initiation of therapy and every 3 months thereafter for at least 48 months after the last dose is administered. a Continue thyroid testing after 48 months if clinically indicated. a (See Thyroid Disorders under Cautions.) In patients with RRMS, obtain baseline and annual dermatologic examinations to monitor for melanoma. a (See Boxed Warning.) Pneumonitis Pneumonitis, including hypersensitivity pneumonitis and pneumonitis with fibrosis, reported in patients receiving alemtuzumab for RRMS. a Manifestations include dyspnea, cough, wheezing, chest pain or tightness, and hemoptysis. a Other Alemtuzumab Preparations Alemtuzumab (Lemtrada ) for treatment of RRMS contains same active ingredient as alemtuzumab (Campath ) for treatment of B-CLL; increased monitoring for additive, long-term effects may be necessary in patients currently receiving Lemtrada who have previously received Campath . a Suicidality In clinical studies in patients with RRMS, attempted suicide or suicidal ideation reported in both alemtuzumab and interferon beta-1a treatment groups. a Advise patients to report any symptoms of depression or suicidal ideation to their clinician. a Immunosuppression Risk of severe and profound lymphopenia, which may increase the potential for transfusion-associated graft versus host disease. 1 2 Administer only irradiated blood products unless immediate transfusion is required because of emergency. 1 Immunogenicity Potential for immunogenicity with use of all therapeutic proteins including alemtuzumab. 1 Development of antibodies (including neutralizing antibodies) to alemtuzumab reported; however, clinically important effects not observed. 1 a Immunization Avoid immunization with live virus vaccines in patients who have recently received alemtuzumab (safety not established). 1 a Complete any necessary immunizations 6 weeks prior to initiating therapy. a Injection Site Reactions Risk of localized skin and injection site reactions (e.g., erythema, edema, pruritus, pain) with sub-Q administration in patients receiving the drug for B-CLL, especially during first 1 2 weeks of therapy; may occur more frequently in previously untreated patients. 34 35 36 Specific Populations Pregnancy Category C. 1 a No adequate and well-controlled studies in pregnant women; however, embryolethality demonstrated in animals. a Use during pregnancy only if potential benefits justify potential risk to fetus. a Contraceptive measures recommended. 1 a (See Advice to Patients.) Alemtuzumab may induce autoimmune thyroid disorders, which can increase the risk of complications in pregnant women and developing fetuses. a (See Thyroid Disorders under Cautions) Placental transfer of anti-thyrotropin receptor antibodies may occur in pregnant women who develop Graves' disease following alemtuzumab therapy; at least one case of neonatal Graves' disease with thyroid storm reported as a result of such placental transfer. a Lactation Not known whether alemtuzumab is distributed into milk; 1 a discontinue nursing or the drug. 1 a Pediatric Use Safety and efficacy not established. 1 5 a Use not recommended in pediatric patients because of potentially serious adverse effects associated with the drug (e.g., autoimmunity, infusion reactions, malignancies). a Geriatric Use Insufficient experience in patients 65 years of age to determine whether geriatric patients respond differently than younger adults. 1 a Hepatic Impairment Pharmacokinetics not evaluated. 1 Safety and efficacy not established. 5 Renal Impairment Pharmacokinetics not evaluated. 1 Safety and efficacy not established. 5 Common Adverse Effects Patients with B-CLL: Infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), 1 cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), 1 infections (e.g., CMV viremia, CMV infection, other infections), 1 adverse GI effects (nausea, vomiting, diarrhea, abdominal pain), 1 adverse neurologic effects (insomnia, anxiety). 1 Patients with RRMS: Rash, a headache, a pyrexia, a nasopharyngitis, a nausea, a urinary tract infection, a fatigue, a insomnia, a upper respiratory tract infection, a herpes virus infection, a urticaria, a pruritus, a thyroid disorders, a fungal infection, a arthralgia, a extremity pain, a back pain, a diarrhea, a sinusitis, a oropharyngeal pain, a paresthesia, a dizziness, a abdominal pain, a flushing, a vomiting. a Interactions for Campath No formal drug interaction studies to date. 1 5 Vaccines Do not administer live vaccines to patients who have recently received a course of alemtuzumab therapy. a Specific Drugs Drug Interaction Comments Antineoplastic agents Potential for increased immunosuppression and risk of infection a Immunosuppressive agents Potential for increased immunosuppression and risk of infection a Campath Pharmacokinetics Absorption Bioavailability In patients with RRMS, serum concentrations of alemtuzumab increase with each consecutive dose within a treatment course. a Distribution Extent Not known whether alemtuzumab crosses the placenta or is distributed into milk; 1 however, human IgG crosses the placenta and is distributed into milk. 1 Elimination Elimination Route Likely metabolized by proteolytic degradation to small peptides and amino acids. 4 Clearance decreases with repeated administration secondary to decreased receptor-mediated clearance (i.e., loss of CD52 receptors in periphery); AUC increases substantially (sevenfold) after 12 weeks of IV dosing in B-CLL patients receiving recommended dosages. 1 Half-life Patients with B-CLL: Mean half-life is 11 hours (range: 2 32 hours) following the first 30-mg IV dose; mean half-life is 6 days (range: 1 14 days) following the last 30-mg IV dose. 1 Patients with RRMS: Half-life is approximately 2 weeks. a Serum alemtuzumab concentrations generally undetectable within 30 days after each treatment course. a Stability Storage Parenteral Concentrate for IV infusion (Campath ) 2 8 C. 1 Do not freeze; if accidentally frozen, thaw at 2 8 C before administration. 1 Protect from direct sunlight. 1 Following dilution, may store at 15 30 C or under refrigeration (2 8 C); use within 8 hours. 1 5 Protect from light. 1 Concentrate for IV infusion (Lemtrada ) 2 8 C in original carton; protect from light. a Do not freeze or shake. a Following dilution, may store at room temperature (15 30 C) or under refrigeration (2 8 C) for up to 8 hours; protect from light. a Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. No incompatibilities observed between alemtuzumab solution and PVC bags, PVC or polyethylene-lined PVC administration sets. 1 Parenteral Solution Compatibility Compatible 1 Dextrose 5% in water Sodium chloride 0.9% Actions An IgG 1 kappa immunoglobulin containing human framework (i.e., variable and constant regions) and murine complementarity-determining regions. 1 3 a Binds specifically to antigen CD52 (expressed on the surface of B and T cells; most monocytes, macrophages, and natural killer cells; and a subpopulation of granulocytes), 1 2 a triggering a host immune response causing lysis of normal and leukemic cells. 1 5 a Mechanism of cell lysis is thought to involve complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. 1 2 Although exact mechanism in MS not fully elucidated, the depletion and repopulation of B and T cells is thought to result in the drug's immunomodulatory effects. a d Advice to Patients Importance of advising patients receiving alemtuzumab (Lemtrada ) for treatment of RRMS to read the manufacturer's patient information (medication guide) prior to each treatment course. a Advise patients that alemtuzumab (Lemtrada ) is available only through a restricted distribution program called the Lemtrada REMS Program. a Inform patients of the requirements of the program and provide them with information on how to locate a certified infusion site. a Advise patients to read the Lemtrada REMS educational materials and to carry the Patient Safety Information Card with them in case of an emergency. a Risk of hematologic toxicity. 1 a Importance of patients immediately informing clinician if signs or symptoms of cytopenias (bleeding, easy bruising, petechiae or purpura, pallor, weakness, or fatigue) occur. 1 Risk of autoimmune diseases such as ITP and anti-glomerular basement membrane disease. a Importance of patients immediately informing clinician if any manifestations of potential autoimmunity (e.g., bleeding, easy bruising, petechiae, purpura, hematuria, edema, jaundice, hemoptysis) occur. a Importance of informing patients receiving alemtuzumab (Lemtrada ) for treatment of RRMS that monthly monitoring of blood cell counts and urine tests is required during and for at least 48 months after completion of therapy. a Risk of infusion-related reactions. 1 a Importance of patients immediately informing clinician if any infusion-related reaction (e.g., swelling of the mouth or throat, difficulty breathing, weakness, abnormal heart rate, chest pain, rash) occurs. a Importance of informing patients receiving alemtuzumab (Lemtrada ) that they will need to be monitored at the healthcare facility (e.g., infusion center) for at least 2 hours after each infusion. a Advise patients that infusion-related reactions may still occur after the 2-hour monitoring period. a Risk of malignancies such as thyroid cancer and melanoma. a Advise patients to report any symptoms of thyroid cancer such as a new lump or swelling in the neck, pain in the front of the neck, persistent hoarseness or other voice changes, difficulty swallowing or breathing, or constant cough not due to upper respiratory tract infection. a Importance of annual skin examinations in patients receiving alemtuzumab (Lemtrada ) to monitor for melanoma. a Risk of infections. 1 a Importance of taking prophylactic anti-infectives as prescribed. 1 a Importance of advising patients to immediately contact their clinician if they develop any signs or symptoms of infection (e.g., fever, swollen glands). 1 a Importance of advising patients to avoid or adequately heat foods that are potential sources of Listeria monocytogenes . a Risk of thyroid disorders (e.g., hyperthyroidism, hypothyroidism). a Importance of advising patients to inform their clinician if they experience any manifestations of a potential thyroid disorder (e.g., unexplained weight loss or gain, rapid heart rate or palpitations, eye swelling, constipation, feeling cold). a Advise patients that irradiation of blood products is required in the event that transfusions are necessary. 1 Importance of patients completing any necessary vaccinations at least 6 weeks prior to the start of alemtuzumab therapy and to consult with their clinician prior to receiving any vaccination after recent use of alemtuzumab. a Advise patients that they should not be immunized with live viral vaccines if they have recently received alemtuzumab. 1 a Risk of pneumonitis; advise patients to report any symptoms such as shortness of breath, cough, wheezing, chest pain or tightness, or hemoptysis. a Advise patients that alemtuzumab (Lemtrada ) for the treatment of RRMS contains the same active ingredient as alemtuzumab (Campath ) for the treatment of B-CLL; patients receiving Lemtrada should inform their clinician if they have previously received Campath . a Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 1 a Advise women of childbearing potential of the need for effective contraception during and for 4 months after a course of alemtuzumab (Lemtrada ) therapy for treatment for MS. a Advise women of childbearing potential and men receiving alemtuzumab (Campath ) to use effective contraceptive methods during therapy and for at least 6 months following completion of therapy. 1 Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses. 1 a Importance of informing patients of other important precautionary information. 1 a (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Distribution of alemtuzumab is restricted. 1 37 (See Restricted Distribution Programs under Dosage and Administration.) Alemtuzumab Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection concentrate, for IV infusion 10 mg/mL (12 mg) Lemtrada Genzyme 30 mg/mL Campath Genzyzme AHFS DI Essentials. Copyright 2017, Selected Revisions January 27, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References 1. Genzyme. Campath (alemtuzumab) prescribing information. Cambridge, MA; 2014 Sep. 2. Flynn JM, Byrd JC. Campath-1H monoclonal antibody therapy. Curr Opin Oncol . 2000; 12:574-81. [PubMed 11085457] 3. Food and Drug Administration. Oncologic drugs advisory committee sixty-sixth meeting. Bethesda, MD; December 2000. From FDA web site. 4. Keating MJ, Flinn I, Jain V et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood . 2002; 99:3554-61. [PubMed 11986207] 5. Berlex Laboratories, Richmond, CA: Personal communication. 6. Chronic lymphocytic leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 May 16. 7. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; [May 5, 2003]. From FDA web site. 8. Anon. Drugs of choice for cancer. Treat Guidel Med Lett . 2003; 1:41-52. [PubMed 15529105] 9. Food and Drug Administration. MedWatch Safety-related drug labeling changes: Campath (alemtuzumab) [May 2004]. From FDA web site. 10. Rai KR, Freter CE, Mercier RJ et al. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol . 2002; 20:3891-7. [PubMed 12228210] 11. Adult non-Hodgkin s lymphoma. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 Jun 06. 12. Lenihan DJ, Alencar AJ, Yang D et al. Cardiac toxicity of alemtuzumab in patients with mycosis fungoides/Sezary syndrome. Blood . 2004; 104:655-8. [PubMed 15073032] 13. Enblad G, Hagberg H, Erlanson M et al. A pilot study of alemtuzumab (anti-CD52 monoclonal antibody) therapy for patients with relapsed or chemotherapy-refractory peripheral T-cell lymphomas. Blood . 2004; 103:2920-4. [PubMed 15070664] 14. Kennedy GA, Seymour JF, Wolf M et al. Treatment of patients with advanced mycosis fungoides and Sezary syndrome with alemtuzumab. Eur J Haematol . 2003; 71:250-6. [PubMed 12950233] 15. Lundin J, Hagberg H, Repp R et al. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood . 2003; 101:4267-72. [PubMed 12543862] 16. Uppenkamp M, Engert A, Diehl V et al. Monoclonal antibody therapy with CAMPATH-1H in patients with relapsed high- and low-grade non-Hodgkin s lymphomas: a multicenter phase I/II study. Ann Hematol . 2002; 81:26-32. [PubMed 11807632] 17. Khorana A, Bunn P, McLaughlin P et al. A phase II multicenter study of CAMPATH-1H antibody in previously treated patients with nonbulky non-Hodgkin s lymphoma. Leuk Lymphoma . 2001; 41:77-87. [PubMed 11342359] 18. Lundin J, Osterborg A, Brittinger G et al. CAMPATH-1H monoclonal antibody in therapy for previously treated low-grade non-Hodgkin s lymphomas: a phase II multicenter study. European Study Group of CAMPATH-1H Treatment in Low-Grade Non-Hodgkin s Lymphoma. J Clin Oncol . 1998; 16:3257-63. [PubMed 9779699] 19. Tang SC, Hewitt K, Reis MD et al. Immunosuppressive toxicity of CAMPATH1H monoclonal antibody in the treatment of patients with recurrent low grade lymphoma. Leuk Lymphoma . 1996; 24:93-101. [PubMed 9049965] 20. Osterborg A, Dyer MJ, Bunjes D et al. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia. J Clin Oncol . 1997; 15:1567-74. [PubMed 9193354] 21. Lundin J, Kennedy B, Dearden C et al. No cardiac toxicity associated with alemtuzumab therapy for mycosis fungoides/Sezary syndrome. Blood . 2005; 105:4148-9. [PubMed 15867423] 22. Damaj G, Rubio MT, Audard V et al. Severe cardiac toxicity after monoclonal antibody therapy. Eur J Haematol . 2002; 68:324. [PubMed 12144543] 23. Herbert KE, Prince HM, Westerman DA. Pure red-cell aplasia due to parvovirus B19 infection in a patient treated with alemtuzumab. Blood . 2003; 101:1654. [PubMed 12560244] 24. Crowley B, Woodcock B. Red cell aplasia due to parvovirus b19 in a patient treated with alemtuzumab. Br J Haematol . 2002; 119:279-80. [PubMed 12358942] 25. Pawson R, Dyer MJ, Barge R et al. Treatment of T-cell prolymphocytic leukemia with human CD52 antibody. J Clin Oncol . 1997; 15:2667-72. [PubMed 9215839] 26. Dearden CE, Matutes E, Cazin B et al. High remission rate in T-cell prolymphocytic leukemia with CAMPATH-1H. Blood . 2001; 98:1721-6. [PubMed 11535503] 27. Keating MJ, Cazin B, Coutre S et al. Campath-1H treatment of T-cell prolymphocytic leukemia in patients for whom at least one prior chemotherapy regimen has failed. J Clin Oncol . 2002; 20:205-13. [PubMed 11773171] 28. Dearden CE, Matutes E, Cazin B et al. Very high response rates in previously untreated T-cell prolymphocytic leukaemia patients receiving alemtuzumab (Campath-1H) therapy. Blood . 2003; 102:644a. 29. Polman CH, Uitdehaag BM. New and emerging treatment options for multiple sclerosis. Lancet Neurol . 2003; 2:563-6. [PubMed 12941579] 30. Genzyme Corporation. Fludara plus alemtuzumab (Campath, MabCampath) vs Fludara alone in B-cell chronic lymphocytic leukemia (B-CLL) patients. National Cancer Institute: Clinical Trials (database). Protocol ID: CAM-314. Last accessed: 810/2008. 31. Hillmen P, Skotnicki AB, Robak T et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol . 2007; 25:5616-23. [PubMed 17984186] 32. FDA Alert: Alemtuzumab (marketed as Campath). Food and Drug Administration; 2005 Nov 30. (AHFS DI 2007rev: p.10, yellow) 33. Rai KR, Peterson BL, Appelbaum FR et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med . 2000; 343:1750-7. [PubMed 11114313] 34. Lundin J, Kimby E, Björkholm M et al. Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood . 2002; 100:768-73. [PubMed 12130484] 35. Stilgenbauer S, Zenz T, Winkler D et al. Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol . 2009; 27:3994-4001. [PubMed 19597025] 36. Osterborg A, Foà R, Bezares RF et al. Management guidelines for the use of alemtuzumab in chronic lymphocytic leukemia. Leukemia . 2009; 23:1980-8. [PubMed 19626051] 37. Genzyme Corporation. US Campath Distribution Program. From product web site. Accessed 2015 July 28. 40. Elter T, Gercheva-Kyuchukova L, Pylylpenko H et al. Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a randomised phase 3 trial. Lancet Oncol . 2011; 12:1204-13. [PubMed 21992852] a. Genzyme Corporation. Lemtrada (alemtuzumab) injection for intravenous use prescribing information. Cambridge, MA; 2014 Nov. b. Coles AJ, Twyman CL, Arnold DL et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet . 2012; 380:1829-39. [PubMed 23122650] c. Cohen JA, Coles AJ, Arnold DL et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet . 2012; 380:1819-28. [PubMed 23122652] d. Garnock-Jones KP. Alemtuzumab: a review of its use in patients with relapsing multiple sclerosis. Drugs . 2014; 74:489-504. [PubMed 24604792] e. Lemtrada risk evaluation and mitigation strategy (REMS). From FDA website. Accessed 2015 May 19. Next Interactions Print this page Add to My Med List More about Campath (alemtuzumab) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: CD52 monoclonal antibodies Consumer resources Campath Campath (Advanced Reading) Professional resources Campath (FDA) Alemtuzumab (AHFS Monograph) Other brands: Lemtrada Related treatment guides Chronic Lymphocytic Leukemia ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class CD52 monoclonal antibodies Related Drugs Chronic Lymphocytic Leukemia Rituxan , rituximab , cyclophosphamide , Imbruvica , Cytoxan , ibrutinib , bendamustine , Venclexta , Octagam , obinutuzumab , Leukeran , chlorambucil , Gazyva , Zydelig , alemtuzumab , Bendeka , fludarabine , Arzerra , Treanda , idelalisib , venetoclax , Carimune , ofatumumab , Flebogamma , Rituxan Hycela , More... 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