FDA update to darunavir label: severe skin reactions
13 August 2012. Related: Antiretrovirals.
Updates to the darunavir (Prezista) package insert were approved on June 1, 2012 and include the following:
Addition of acute generalised exanthematous pustulosis (an acute skin eruption of characterised by numerous small, sterile pustules) to the warnings and precautions (severe skin reaction) and adverse reactions (postmarketing experience) sections.
Revisions to drugs interactions and clinical pharmacology sections included boceprevir drug-drug interaction information. Specifically, concomitant administration of darunavir/ritonavir and boceprevir resulted in reduced steady-state exposures to darunavir and boceprevir. It is not recommended to co-administer boceprevir and darunavir/ritonavir.
The full updated labeling will be posted on the FDA website.