II. Background

  1. Alemtuzumab is no longer commercially available in the U.S. as of 2012
    1. Still available via a restricted access program

III. Indications

  1. Chronic Lymphocytic Leukemia (refractory)
    1. Alemtuzumab (Campath)
  2. Multiple Sclerosis (remitting, not responding to 2 or more disease modifying drugs)
    1. Alemtuzumab (Lamtrada)

IV. Contraindications

V. Precautions

  1. Prevaccinate against Varicella Zoster Virus if not immune at least 6 weeks before treatment
  2. Screen for Tuberculosis before treatment
  3. Avoid Listeria monocytogenes sources (Deli Meat, unpasteurized milk including derived soft cheese)

VI. Mechanism

  1. CD52
    1. Glycoprotein expressed on the surface of most B and T cells, Monocytes, Macrophages and Natural Killer Cells
    2. Also expressed on some Granulocytes, and male genitourinary tissue
  2. Anti-CD52 Monoclonal Antibody
    1. Recombinant human Monoclonal Antibody directed against the CD52 Antigen cell surface marker
    2. Bind CD52 and triggers a cytotoxic immune response, depleting CD52 positive Cells

VII. Dosing: Multiple Sclerosis

  1. See other references for disease specific dosing protocols in oncology
  2. General
    1. Monitor for at least 2 hours after each infusion
    2. Coadministered medications
      1. Methylprednisolone 1000 mg immediately before infusion
      2. Herpes Antiviral prophylaxis of at least 2 months after dose (or CD4 Count >200 cells/ml)
  3. Multiple Sclerosis
    1. Course 1
      1. Give 12 mg/1.2 ml IV infusion over 4 hours daily for 5 consecutive days
    2. Course 2 (given 12 months after course 1)
      1. Give 12 mg/1.2 ml IV infusion over 4 hours daily for 3 consecutive days

VIII. Adverse Effects

  1. Infusion Reactions
    1. Anaphylaxis
  2. Cerebrovascular Accident
  3. Secondary Autoimmunity
    1. Immune Thrombocytopenic Purpura
    2. Hemolytic Anemia
    3. Anti-Glomerular Basement Membrane Disease
    4. Autoimmune Hepatitis
  4. Secondary Malignancy
    1. Thyroid Cancer
    2. Melanoma
    3. Lymphoproliferative disorders
  5. Myelosuppression
  6. Progressive Multifocal Leukoencephalopathy
  7. Acquired Hemophilia A

IX. Safety

  1. Avoid in Lactation
  2. Avoid in pregnancy (all trimesters, Pregnancy category X)
    1. Use reliable Contraception
  3. Monitoring (labs at baseline, then monthly, then periodically for 48 months after last dose)
    1. Complete Blood Count
    2. Serum Creatinine
    3. Urinalysis
    4. Thyroid Stimulating Hormone (every 3 months)

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Related Studies

Ontology: alemtuzumab (C0383429)

Definition (NCI) Any monoclonal antibody directed against the cell surface glycoprotein CD52, regardless of the antibody type (e.g., rat, mouse, humanized).
Definition (NCI) A recombinant DNA-derived humanized monoclonal antibody directed against the cell surface glycoprotein, CD52. Alemtuzumab is an IgG1 kappa with human variable framework and constant regions, and complementarity-determining regions derived from a rat monoclonal antibody. This agent selectively binds to CD52, thereby triggering a host immune response that results in lysis of CD52 + cells. CD52 is a glycoprotein expressed on the surface of essentially all normal and malignant B and T cells, a majority of monocytes, macrophages and natural killer (NK) cells, a subpopulation of granulocytes, and tissues of the male reproductive system. (NCI04)
Definition (NCI_NCI-GLOSS) A type of monoclonal antibody used in the treatment of leukemia. Monoclonal antibodies are laboratory-produced substances that can locate and bind to cancer cells.
Definition (PDQ) A recombinant DNA-derived humanized monoclonal antibody directed against the cell surface glycoprotein, CD52. Alemtuzumab is an IgG1 kappa with human variable framework and constant regions, and complementarity-determining regions derived from a rat monoclonal antibody. This agent selectively binds to CD52, thereby triggering a host immune response that results in lysis of CD52 + cells. CD52 is a glycoprotein expressed on the surface of essentially all normal and malignant B and T cells, a majority of monocytes, macrophages and natural killer (NK) cells, a subpopulation of granulocytes, and tissues of the male reproductive system. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=37783&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=37783&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C1681" NCI Thesaurus)
Concepts Pharmacologic Substance (T121) , Immunologic Factor (T129) , Amino Acid, Peptide, or Protein (T116)
MSH C096529
SnomedCT 391632007, 129472003
English Monoclonal Antibody CD52, MoAb CD52, anti-CD52 monoclonal antibody, alemtuzumab (medication), Anti-CD52 Monoclonal Antibody, Anti-CD52 Antibody, ALEMTUZUMAB, Alemtuzumab (Obsolete), alemtuzumab [Chemical/Ingredient], alemtuzumab, LDP-03, Alemtuzumab (product), Alemtuzumab (substance), Alemtuzumab
Spanish alemtuzumab (producto), alemtuzumab (sustancia), alemtuzumab