FDA label
What is Symtuza used for?
Symtuza contains darunavir, cobicistat, emtricitabine and tenofovir alafenamide. 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: “SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg: who have no prior antiretroviral treatment history or; who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions assoc...”
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Symtuza, tablet, film coated
Indications and Usage, quoted from the label by Janssen Products LP (NDA210455). Cross-references to other label sections are left out.
SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg:
- who have no prior antiretroviral treatment history or
- who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir.
Source: DailyMed label, set id 85a17d00-6b7c-41ea-a6b3-5ad924820dab, version 23, effective April 17, 2026. NDC 59676-800, one of 1 listing for this product.
Questions
What is Symtuza used for?
The FDA label says: “SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg: who have no prior antiretroviral treatment history or; who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions assoc...”
What drug class is Symtuza?
FDA lists darunavir, cobicistat, emtricitabine and tenofovir alafenamide in the Cytochrome P450 3A Inhibitor and Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor and 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.
More on Symtuza
- Is Symtuza a controlled substance?Federal schedule
- Generic for SymtuzaFDA Orange Book
- Cytochrome P450 3A Inhibitors listFDA drug class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Protease Inhibitors listFDA drug class
- Symtuza Medicare Part D coverageBy plan and state
- NDC 59676-800Symtuza NDC record