HTB

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):

http://www.accessdata.fda.gov/scripts/cder/drugsatfda

Source: FDA list serve (27 January 2010)

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