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