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

Recommendations for Physicians5

Slide 17a

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.

Recommendations for Physicians5


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