December 13, 2010
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FDA approves new labeling for darunavir

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The FDA has approved new package labeling for darunavir, which now includes a once-daily dosing for adult patients with no prior resistance to darunavir associated substitutions, according to a press release.

Major changes to the package insert for darunavir (Prezista, Tibotec Pharmaceuticals) include:

  • Recommended oral dose for treatment-experienced adult patients with no darunavir resistance associated substitutions is 800 mg once-daily darunavir with100 mg once-daily ritonavir, to be taken with food.
  • Recommended oral dose for treatment-experienced adult patients with at least one darunavir resistance associated substitution is 600 mg twice-daily darunavir taken with 100 mg twice-daily ritonavir, to be taken with food.
  • For antiretroviral-treatment-experienced patients genotypic testing is recommended. However, when genotypic testing is not feasible, darunavir 600 mg in combination with ritonavir 100 mg twice-daily dosing is recommended.

Other minor changes to the package insert and patient package insert were made for consistency and can be found at www.fda.gov/default.htm.

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