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

Information for Patients⁵

November 2008

For the patients, providers should inform them that they are at greater risk for serious allergic reactions when first starting treatment with abacavir or with combined therapy that contains abacavir.

Patients should be aware that HLA-B*5701 status, which is a risk-factor for these hypersensitivity reactions, should be determined prior to starting abacavir therapy.

Patients should also know that these they are at high risk for hypersensitivity reaction if their laboratory tests are positive.

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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?