FDA label
What is Jakafi used for?
Jakafi contains ruxolitinib. 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 for Jakafi lists 4 uses: Myelofibrosis; Polycythemia Vera; Acute Graft-Versus-Host Disease; Chronic Graft-Versus-Host Disease.
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Jakafi, tablet
Indications and Usage, quoted from the label by Incyte Corporation (NDA202192). Cross-references to other label sections are left out.
Myelofibrosis
JAKAFI/JAKAFI XR is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF in adults.
Polycythemia Vera
JAKAFI/JAKAFI XR is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Acute Graft-Versus-Host Disease
JAKAFI/JAKAFI XR is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
Chronic Graft-Versus-Host Disease
JAKAFI/JAKAFI XR is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Source: DailyMed label, set id f1c82580-87ae-11e0-bc84-0002a5d5c51b, version 42, effective July 20, 2026. NDC 50881-005, one of 5 listings for this product.
Questions
What is Jakafi used for?
The FDA label for Jakafi lists 4 uses: Myelofibrosis; Polycythemia Vera; Acute Graft-Versus-Host Disease; Chronic Graft-Versus-Host Disease.
What drug class is Jakafi?
FDA lists ruxolitinib in the Janus Kinase Inhibitor and Kinase 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 Jakafi
- Is Jakafi a controlled substance?Federal schedule
- Generic for JakafiFDA Orange Book
- Generic for OpzeluraFDA Orange Book
- Generic for Jakafi XRFDA Orange Book
- Janus Kinase Inhibitors listFDA drug class
- Kinase Inhibitors listFDA drug class
- Jakafi Medicare Part D coverageBy plan and state
- NDC 50881-005Jakafi NDC record
- NDC 50881-010Jakafi NDC record
- NDC 50881-015Jakafi NDC record