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PREZISTA(R) Now Available for Pediatric Patients Six Years of Age and Older as part of HIV Combination Therapy
Date:2/11/2009

methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, or simvastatin).
  • Coadministration of PREZISTA/r is also contraindicated with rifampin and products containing St. John's wort (Hypericum perforatum) because this may cause significant decrease in plasma concentration of darunavir, resulting in loss of therapeutic effect and development of resistance.
  • Coadministration is not recommended with indinavir, lopinavir/ritonavir, saquinavir, and pravastatin.
  • Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/r. This list of potential drug interactions is not complete.
  • Additional Important Safety Information

    • Do not use PREZISTA/r in pediatric patients below 3 years of age. The safety and efficacy of PREZISTA/r in pediatric patients 3 to < 6 years of age have not been established.
    • PREZISTA must be coadministered with ritonavir and food to achieve the desired antiviral effect. Failure to administer PREZISTA with ritonavir and food may result in a loss of efficacy of darunavir. Please refer to ritonavir prescribing information for additional information on precautionary measures.
    • Drug-induced hepatitis (eg, acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/r. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse events.

    Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA/r therapy has not been established.

    Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/r and patients shoul
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    SOURCE Tibotec Therapeutics
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