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efalizumab (Raptiva)

Tradename: Raptiva (FDA approved 2003) (withdrawn from US market June 2009 due to risk of PML) Indications: -> moderate to severe plaque psoriasis Dosage: injection SQ weekly (cost $14,000/year) Monitor: platelet count monthly for 1st 3 months, then every 3 months Adverse effects: 1) thrombocytopenia 2) complications of immunosuppression a) infection [4] - necrotizing fasciitis - tuberculous pneumonia - bacterial sepsis with seeding of distant sites - severe pneumonia with neutropenia - worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment - viral meningitis - invasive fungal disease - progressive multifocal leukoencephalopathy b) malignancy 3) immune-mediated hemolytic anemia [4] 5) life-threatening infections, including [5,7] a) bacterial sepsis b) viral meningitis c) invasive fungal disease d) progressive multifocal leukoencephalopathy (PML) [7] e) other opportunistic infections Mechanism of action: -> monoclonal antibody: blocks T-cells

Interactions

drug adverse effects of immunosuppressive agents monitor with immunosuppressive agents

General

pharmaceutical monoclonal antibody immunosuppressive agent

References

  1. Prescriber's Letter 10(12):69 2003
  2. Leonardi CL, Efalizumab: an overview. N Engl 349:2014, 2003 PMID: 12894132
  3. Journal Watch 24(1):11, 2004 Lebwohl M et al, N Engl J Med 349:2004, 2003 PMID: 14627785 Leonardi CL et al, N Engl J Med 349:2014, 2003 PMID: 14627786
  4. FDA Medwatch http://www.fda.gov/medwatch/safety/2005/safety05.htm#Raptiva
  5. FDA Medwatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Raptiva
  6. FDA patient safety news http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=83#1
  7. FDA MedWatch http://www.fda.gov/medwatch/safety/2009/safety09.htm#Raptiva