FDA label
What is Isentress used for?
Isentress contains raltegravir. 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: “Adult Patients:”
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Isentress, tablet, film coated
Indications and Usage, quoted from the label by Merck Sharp & Dohme LLC (NDA022145). Cross-references to other label sections are left out.
Adult Patients:
ISENTRESS® and ISENTRESS® HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
Pediatric Patients:
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg.
ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg.
Source: DailyMed label, set id 89a5ec53-d956-4329-8004-0f40f51c88a3, version 71, effective October 18, 2024. NDC 0006-0227, one of 5 listings for this product.
Questions
What is Isentress used for?
The FDA label says: “Adult Patients:”
What drug class is Isentress?
FDA lists raltegravir 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 Isentress
- Is Isentress a controlled substance?Federal schedule
- Generic for IsentressFDA Orange Book
- What is Raltegravir used for?FDA label uses
- Is Raltegravir a controlled substance?Federal schedule
- Generic for Isentress HdFDA Orange Book
- Human Immunodeficiency Virus Integrase Strand Transfer Inhibitors listFDA drug class
- NDC 0006-0227Isentress NDC record
- NDC 0006-0473Isentress NDC record
- NDC 0006-0477Isentress NDC record