Darunavir once-daily indication in treatment experienced adults

1 February 2011. Related: Antiretrovirals.

On 13 December 2010, FDA approved new labeling for darunavir (Prezista) to include a once-daily dosing for treatment-experienced adult patients who have no darunavir-associated resistance mutations.

Darunavir-associated mutations are V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V.

For patients without darunavir-associated mutations the dose is 800 mg darunavir once daily with ritonavir 100 mg once daily and with food.

For patients with one or more darunavir-associated mutations* the indication remains 600 mg darunavir twice-daily taken with ritonavir 100 mg twice-daily and with food.

Adverse reactions (Section 6.3) was modified to include neutropenia, lipoatrophy, and lipodystrophy under Postmarketing Events in the package inserts.

For details of other changes, please refer to the full prescribing labeling:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm