DRUG WARNING: DARUNAVIR (PREZISTA)

On May 12, 2008, Tibotec, a division of Janssen-Ortho Inc., following discussions with Health Canada, released a letter with important new safety information regarding hepatotoxicity in association with the use of darunavir (Prezista).

Drug-induced hepatotoxicity has been reported in patients receiving darunavir therapy in combination with ritonavir (rtv) during clinical trials and post-marketing use. Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/rtv and patients’ liver enzymes should be monitored during treatment.

If new or worsening liver dysfunction (including significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, or hepatomegaly) develops in patients using darunavir/rtv, interruption or discontinuation of treatment must be considered.

Tibotec is working with Health Canada to incorporate this new safety information in the Canadian Product Monograph for Prezista.

For more information: Click here to download the Warning letter issued by Tibotec

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The BC-CfE Laboratory is streamlining reporting processes for certain tests in order to simplify distribution and record-keeping, and to ensure completeness of results. Beginning September 2, 2025, results for the ‘Resistance Analysis of HIV-1 Protease and Reverse Transcriptase’ (Protease-RT) and ‘HIV-1 Integrase Resistance Genotype’ tests will be combined into a single ‘HIV-1 Resistance Genotype Report’.
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