FDA label

What is Rukobia used for?

Rukobia contains fostemsavir. 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: “RUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.”

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Rukobia, tablet, film coated, extended release

Indications and Usage, quoted from the label by ViiV Healthcare Company (NDA212950). Cross-references to other label sections are left out.

RUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Source: DailyMed label, set id a21006b7-6d6f-4f06-81b4-17978756452b, version 9, effective February 13, 2024. NDC 49702-250, one of 1 listing for this product.

Questions

What is Rukobia used for?

The FDA label says: “RUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.”

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.

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