FDA updates US label for darunavir (Prezista)

On 27 January 2010, the FDA approved revisions to the darunavir (Prezista) product labeling to include the 96 week data from two trials; one trial in treatment-experienced patients (TMC114-C214) and one trial in treatment-naive patients (TMC114-C211).

Additional revisions included:

  • Updating the contraindications to include for alfuzosin
  • Adding drug hypersensitivity, angioedema and urticaria as less common adverse reactions
  • Adding a new section to identify osteonecrosis as an Adverse Drug Reaction (ADR).
  • Including redistribution of body fat and toxic epidermal necrolysis as potential side effects (from post-marketing reports).
  • Updating maraviroc drug interaction data. In summary maraviroc concentrations are increased when co-administered with darunavir/ritonavir, requiring a dose reduction of maraviroc to 150 mg twice daily.
  • Additional resistance data and baseline genotype and phenotype virologic analyses and cross-resistance data were also included.

The updated labeling will be posted to the FDA website (Prezista):

Source: FDA list serve (27 January 2010)

Links to other websites are current at date of posting but not maintained.