What the FDA Relabeling of Abacavir Means for You and Your Patient

Recommendations for Physicians⁵

November 2008

For those patients who are HLA-B*5701 negative by laboratory testing, there is still a residual risk for developing abacavir hypersensitivity reaction. Because, as you remember from previous slides, the negative predictive value is not 100% so these HLA-B*5701-negative patients should still be monitored for signs and symptoms of a possible hypersensitivity reaction to abacavir.

If the patient becomes seriously ill and a hypersensitivity reaction cannot be ruled out, discontinue abacavir therapy permanently, regardless of HLA-B*5701 status.

In addition, prescribers should not restart abacavir or any abacavir-containing drug combination following occurrence of abacavir hypersensitivity reaction. This is because severe symptoms can occur within hours of reinitiating and can result in life-threatening hypotension and death.

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Jump to section:

• Introduction
• Highly Active Antiretroviral Therapy
• Abacavir
• FDA Caution and Relabeling
• Abacavir Hypersensitivity
• Abacavir HSR and HLA Gene
• HLA-B Antigens and Alleles
• Naming Conventions - HLA-B*5701
• Chromosome 6
• Detecting HLA Alleles
• HLA-B*5701 Correlations
• HLA-B*5701 Correlations
• Clinical Utility³
• Problems
• If HSR Symptoms are Present⁴
• If HSR Symptoms are Present⁴
• Recommendations for Physicians⁵
• Recommendations for Physicians⁵
• Information for Patients⁵
• Information for Patients⁵
• HLA-B*5701 Genotyping
• References
• Questions?