Alemtuzumab

CAMPATH binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52.

• CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).ICD-10: C95.90

• None.contraindicated

Administer as an intravenous infusion over 2 hours. ( 2.1 ) Escalate to recommended dose of 30 mg/day three times per week for 12 weeks. ( 2.1 ) Premedicate with oral antihistamine and acetaminophen. ( 2.2 ) 2.1 Dosing Schedule and Administration Administer as an intravenous infusion over 2 hours. Do not administer as intravenous push or bolus. Recommended Dosing Regimen Gradually escalate to the maximum recommended single dose of 30 mg. Escalation is required at initiation of dosing or if dosing is held ≥7 days during treatment. Escalation to 30 mg ordinarily can be accomplished in 3 to 7 days. Escalation Strategy: – Administer 3 mg daily until infusion-related reactions are ≤ Grade 2 [see Adverse Reactions (6.1) ] . – Then administer 10 mg daily until infusion-related reactions are ≤ Grade 2. – Then administer 30 mg/day three times per week on alternate days (e.g., Mon-Wed-Fri). The total duration of therapy, including dose escalation, is 12 weeks. Single doses of greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia. 2.2 Recommended Concomitant Medications Premedicate with diphenhydramine (50 mg) and acetaminophen (500–1000 mg) 30 minutes prior to first infusion and each dose escalation. Institute appropriate medical management (e.g., glucocorticoids, epinephrine, meperidine) for infusion-related reactions as needed [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] .

Cytopenias : Obtain complete blood counts (CBC) and platelet counts at weekly intervals during therapy and CD4 counts after therapy until recovery to ≥200 cells/µL. Withhold for severe cytopenias. Discontinue for autoimmune or severe hematologic adverse reactions. ( 2.2 , 5.1 ) Immunosuppression/Infections : CAMPATH induces severe and prolonged lymphopenia and increases risk of infection. If a serious infection occurs, withhold treatment until infection resolves. ( 5.3 ) Immunization : Do not administer live viral vaccines to patients who have recently received CAMPATH. ( 5.4 ) 5.1 Cytopenias Severe, including fatal, autoimmune anemia and thrombocytopenia, and prolonged myelosuppression have been reported in patients receiving CAMPATH. In addition, hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia have been reported after treatment with CAMPATH at the recommended dose. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia. Withhold CAMPATH for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia) [see Dosage and Administration (2.3) ] . No data exist on the safety of CAMPATH resumption in patients with autoimmune cytopenias or marrow aplasia [see Adverse Reactions (6.1) ] . Obtain complete blood counts (CBC) at weekly intervals during CAMPATH therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Cytopenias [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Immunosuppression/Infections [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥10%): cytopenias, infusion-related reactions, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-877-4-CAMPATH (1-877-422-6728) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data below reflect exposure to CAMPATH in 296 patients with CLL of whom 147 were previously untreated and 149 received at least 2 prior chemotherapy regimens. The median duration of exposure was 11.7 weeks for previously untreated patients and 8 weeks for previously treated patients. The most common adverse reactions with CAMPATH are: infusion-related reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), infections (CMV viremia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety).

Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies, CAMPATH may cause fetal harm when administered to a pregnant woman. Available data from published cohort studies in pregnant women are insufficient to establish a CAMPATH-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Alemtuzumab was embryolethal in pregnant huCD52 transgenic mice when administered during organogenesis (see Data ) . Human IgG antibodies are known to cross the placental barrier; therefore, CAMPATH may be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. Infants born to pregnant women treated with CAMPATH may be at increased risk of infection (see Clinical Considerations ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

CAMPATH pharmacokinetics were characterized in a study of 30 previously treated B-CLL patients in whom CAMPATH was administered at the recommended dose and schedule. After 12 weeks of dosing, patients exhibited a 7-fold increase in mean AUC.

Across all clinical experience, the reported maximum single dose received was 90 mg. Bone marrow aplasia, infections, or severe infusion-related reactions occurred in patients who received a dose higher than recommended. One patient who received an 80 mg dose intravenously experienced acute bronchospasm, cough, and dyspnea, followed by anuria and death. Another patient received two 90 mg doses intravenously one day apart during the second week of treatment and experienced a rapid onset of bone marrow aplasia. There is no known specific antidote for CAMPATH overdosage. Discontinue CAMPATH and provide supportive therapy.

• May 7, 2001BLABLA103948Genzyme

1. 1Headache1,8929.9%
2. 2Fatigue1,8649.8%
3. 3Pyrexia1,7709.3%
4. 4Off Label Use1,6268.5%
5. 5Rash1,1906.2%
6. 6Nausea1,1826.2%
7. 7Drug Ineffective1,0135.3%
8. 8Dyspnoea9835.1%
9. 9Asthenia9394.9%
10. 10Multiple Sclerosis Relapse9074.7%
11. 11Lymphocyte Count Decreased8764.6%
12. 12Cytomegalovirus Infection8404.4%
13. 13Urinary Tract Infection8154.3%
14. 14Pain7523.9%
15. 15Condition Aggravated7183.8%

Recent PubMed references pinned to Alemtuzumab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Lymphopenia predicts infectious complications after alemtuzumab therapy in multiple sclerosis: Real-world experience from a Brazilian cohort.
  Clinical neurology and neurosurgery · 2026 · Tejo AM, Silva GD, de Holanda AC, et al.
  PMID 42173025DOI 10.1016/j.clineuro.2026.109497
• [Alemtuzumab-based HLA-haploidentical transplantation for relapsed/refractory aggressive NK-cell leukemia].
  [Rinsho ketsueki] The Japanese journal of clinical hematology · 2026 · Komori Y, Kawata E, Yamaguchi J, et al.
  PMID 42128859DOI 10.11406/rinketsu.67.303
• Real-world cost of disease-modifying treatments administered by intravenous infusion in relapsing-remitting multiple sclerosis patients from Argentina.
  Multiple sclerosis and related disorders · 2026 · Silva BA, Federico MB, Lázaro L, et al.
  PMID 41962304DOI 10.1016/j.msard.2026.107173
• Anti-CD52 therapy of rheumatic diseases: Revisited in the era of immune reset.
  Autoimmunity reviews · 2026 · Hassan F, Isaacs JD, Naffaa ME, et al.
  PMID 41956272DOI 10.1016/j.autrev.2026.104056
• Serotherapy in transplant: Getting it right!
  British journal of haematology · 2026 · Wynn R, Admiraal R, Lindemans C, et al.
  PMID 41937680DOI 10.1111/bjh.70456
• Anti-thymocyte globulin (ATG)- or alemtuzumab-based graft-versus-host disease prophylaxis in reduced-intensity conditioning allogeneic hematopoietic cell transplantation (HCT) for patients 40 years and older with acute lymphoblastic leukemia in first complete remission: a study from the EBMT Acute Leukemia Working Party.
  Bone marrow transplantation · 2026 · Bug G, Labopin M, Byrne JL, et al.
  PMID 41792300DOI 10.1038/s41409-026-02805-4
• Alemtuzumab Induction in Septuagenarians Undergoing Deceased Donor Kidney Transplantation.
  Clinical transplantation · 2026 · Harriman DI, Ng A, Farney AC, et al.
  PMID 41782490DOI 10.1111/ctr.70495
• [Translated article] Alemtuzumab in relapsing-remitting multiple sclerosis in clinical practice: Annual NEDA-3 follow-up for up to 4 years.
  Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria · 2026 · Herrero-Poch L, Fortes-González MS, Pato-Pato A, et al.
  PMID 41644330DOI 10.1016/j.farma.2025.12.005

The 10 most recently updated of 390 ClinicalTrials.gov registrations naming Alemtuzumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Partial Stem Cell Transplant for Sickle Cell Disease From Matched Donors
  Recruiting · Phase 1 · Phase 2 · Interventional · 90 enrolled · National Heart, Lung, and Blood Institute (NHLBI)
  NCT07599176updated 2026-06-12
• Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation
  Recruiting · Phase 2 · Interventional · 60 enrolled · Children's Hospital Medical Center, Cincinnati
  NCT05501756updated 2026-06-12
• 131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)
  Recruiting · Phase 1 · Interventional · 24 enrolled · Columbia University
  NCT07015684updated 2026-06-10
• Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide
  Active not recruiting · Early phase 1 · Interventional · 4 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT03910452updated 2026-06-05
• Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
  Not yet recruiting · Phase 2 · Interventional · 20 enrolled · Case Comprehensive Cancer Center
  NCT06084780updated 2026-06-05
• High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 45 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT02629120updated 2026-06-05
• Allo HSCT for High Risk Hemoglobinopathies
  Recruiting · Phase 2 · Interventional · 62 enrolled · Masonic Cancer Center, University of Minnesota
  NCT06872333updated 2026-06-04
• A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
  Active not recruiting · Observational · 1,178 enrolled · Biogen
  NCT05688436updated 2026-06-04
• Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease
  Not yet recruiting · Phase 2 · Interventional · 45 enrolled · St. Jude Children's Research Hospital
  NCT07616154updated 2026-06-01
• Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
  Recruiting · Phase 1 · Phase 2 · Interventional · 29 enrolled · Washington University School of Medicine
  NCT03128996updated 2026-05-29

Frequently asked questions

How does Alemtuzumab work?

CAMPATH binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52.

What is Alemtuzumab used for?

According to FDA labeling, Alemtuzumab carries indications including: CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Alemtuzumab?

Alemtuzumab is classified as Monoclonal antibodies, CD52-directed Cytolytic Antibody, Antibody-Receptor Interactions, CD52-directed Antibody Interactions, Increased Lymphocyte Cell Destruction.

What are the brand names for Alemtuzumab?

Alemtuzumab is marketed under brand names including Campath, Lemtrada.

What are the contraindications for Alemtuzumab?

Alemtuzumab labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.