FDA updates US label for darunavir for serious rash

1 December 2011. Related: Antiretrovirals.

On 19 October 2011 the FDA approved updates to the darunavir (Prezista) package insert to include 192-week results from the Phase 3 registrational studies.

In addition, section 5.3 Severe Skin Reactions now includes the following text about combinations that include darunavir/ritonavir plus raltegravir:

Rash occurred more commonly in treatment-experienced subjects receiving regimens containing darunavir/ritonavir + raltegravir compared to subjects receiving darunavir /ritonavir without raltegravir or raltegravir without darunavir /ritonavir. However, rash that was considered drug related occurred at similar rates for all three groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.

Source:

FDA HIV/AIDS Update – Prezista label update includes 192-week safety, resistance and efficacy data (21 October 2011).

New label and supporting information