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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