FDA label
What is Tivicay used for?
Tivicay contains dolutegravir. 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: “TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) weighing at least 2 kg.”
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Tivicay, tablet, film coated
Indications and Usage, quoted from the label by ViiV Healthcare Company (NDA204790). Cross-references to other label sections are left out.
TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) weighing at least 2 kg.
TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
Source: DailyMed label, set id 63df5af3-b8ac-4e76-9830-2dbb340af922, version 34, effective August 25, 2026. NDC 49702-226, one of 4 listings for this product.
Questions
What is Tivicay used for?
The FDA label says: “TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) weighing at least 2 kg.”
What drug class is Tivicay?
FDA lists dolutegravir in the Human Immunodeficiency Virus Integrase Strand Transfer 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 Tivicay
- Is Tivicay a controlled substance?Federal schedule
- Generic for TivicayFDA Orange Book
- Generic for Tivicay PDFDA Orange Book
- Human Immunodeficiency Virus Integrase Strand Transfer Inhibitors listFDA drug class
- Tivicay Medicare Part D coverageBy plan and state
- NDC 49702-226Tivicay NDC record
- NDC 49702-227Tivicay NDC record
- NDC 49702-228Tivicay NDC record