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alemtuzumab (Campath-1H, Lemtrada)

Indications: 1) treatment of refractory leukemia (B-CLL) (FDA approved 2001) 2) relapsing-remitting multiple sclerosis (Lemtrada) [5]* 3) treatment of mycosis fungoides [3,4] * on list of drugs to avoid for treatment of muliple sclerosis [6] - disproportionate adverse effects cited Contraindications: - pregnancy category: C [3] Dosage: - 12 mg IV daily for 5 days at baseline, then daily for 3 days at 12 months Monitor: - pretreatment screening for varicella vaccination - thyroid function testing every 3 months - monthly CBC, urinalysis, serum creatinine [3] Adverse effects: - infusion reactions including headache, rash - reactivation of viral infection (cytomegalovirus) - infusion-associated reactions (90%) - infection 77%* (mostly mild-to-moderate) - upper respiratory tract infection - urinary tract infection - Herpes virus infection - thyroid disorders (16%) [2] - autoimmune thyroiditis [3] - thyroid papillary carcinoma - immune thrombocytopenia (1%) - hepatotoxicity [6] - stroke, tears in blood vessel walls (rare) [7] * compared with 66% for IFN-beta-1a (infections) Mechanism of action: - binds to CDw52 (CAMPATH-1 antigen) Notes: Manufacturer: Berlex

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

Related

CD52; CAMPATH-1 antigen; Cambridge pathology 1 antigen; epididymal secretory protein E5; CDw52 (CDW52, HE5)

General

antineoplastic monoclonal antibody

References

  1. Prescriber's Letter 9(2):S1 2002
  2. Cohen JA 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 Nov 24; 380:1819. PMID: 23122652 - Coles AJ et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: A randomised controlled phase 3 trial. Lancet 2012 Nov 24; 380:1829. PMID: 23122650
  3. Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18. American College of Physicians, Philadelphia 2012, 2015, 2018.
  4. Galper SL, Smith BD, Wilson LD. Diagnosis and management of mycosis fungoides. Oncology (Williston Park). 2010 May;24(6):491-501. PMID: 20568590
  5. Genzyme's Lemtrada Approved by the FDA Manufacturer's Press Release. November 14, 2014 http://news.genzyme.com/press-release/genzymes-lemtrada-approved-fda
  6. Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
  7. FDA Safety Announcement. Nov 29, 2018 FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab). https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm