FDA label
What is Prezista used for?
Prezista contains darunavir ethanolate. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populationsand Clinical Studies].”
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Prezista, tablet, film coated
Indications and Usage, quoted from the label by Janssen Products LP (NDA021976). Cross-references to other label sections are left out.
PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populationsand Clinical Studies].
Source: DailyMed label, set id 814301f9-c990-46a5-b481-2879a521a16f, version 58, effective August 29, 2025. NDC 59676-562, one of 4 listings for this product.
Questions
What is Prezista used for?
The FDA label says: “PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populationsand Clinical Studies].”
What drug class is Prezista?
FDA lists darunavir ethanolate in the Protease Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.