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)