FDA approved Jakafi (ruxolitinib) for Steroid-Refractory Acute Graft-Versus-Host DiseaseFDA approved Jakafi for acute graft-versus-host disease in patients 12 and older.

FDA From the archive Source published November 16, 2011 Summary added July 24, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Jakafi for steroid-refractory acute GVHD in patients aged 12 years and older.

The FDA has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients aged 12 years and older. This marks a new indication for the JAK1/JAK2 inhibitor, which was previously approved for myelofibrosis, polycythemia vera, and chronic GVHD. The approval provides a targeted therapy option for patients with aGVHD who do not respond to corticosteroids, a condition with limited treatment options and high morbidity. Clinicians should note that the recommended starting dose for aGVHD is 5 mg twice daily (or 11 mg once daily for the extended-release formulation), with dose adjustments based on safety and efficacy.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Ruxolitinib is a kinase inhibitor of Janus associated kinases (JAKs) JAK1 and JAK2. It inhibits cytokine signaling pathways involved in hematopoiesis and immune function.

Indication & Patient Population

Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.

Dosing & Administration

The starting dose of Jakafi for aGVHD is 5 mg given orally twice daily or Jakafi XR 11 mg given orally once daily. Doses should be individualized based on safety and efficacy. Prior to treatment, perform a complete blood count (CBC) and inquire about past infections including tuberculosis, herpes simplex, herpes zoster, and hepatitis B. During treatment, perform a CBC every 2 to 4 weeks until doses are stabilized, then as clinically indicated. Assess lipid parameters approximately 8 to 12 weeks following initiation.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Jakafi is indicated for steroid-refractory acute GVHD in patients 12 years and older, providing a treatment option after failure of corticosteroids.

The FDA has approved Jakafi (ruxolitinib) for a new use: treating acute graft-versus-host disease (aGVHD) in adults and children aged 12 and older. aGVHD is a serious complication that can happen after a stem cell or bone marrow transplant, where the donor cells attack the patient's body. This approval is for patients whose aGVHD does not get better with steroids, a common first treatment.

Jakafi is a type of drug called a JAK inhibitor. It works by blocking certain signals in the body that cause inflammation. It was already approved for other conditions like myelofibrosis and chronic GVHD. This new approval adds to the options for patients with aGVHD, a condition that can be life-threatening and has limited treatments.

The recommended starting dose for aGVHD is 5 mg twice a day (or 11 mg once a day for the extended-release version). The dose may be adjusted based on how well it works and any side effects. This approval is based on studies showing that Jakafi can help control aGVHD in some patients who did not respond to steroids.

It is important to know that this drug is not a cure and may not work for everyone. Patients should talk to their doctor about whether Jakafi is right for them, and discuss potential risks and benefits. As with any new treatment, it is important to follow your healthcare provider's guidance and report any side effects.

What this means for you:

Jakafi is a new option for acute GVHD when steroids don't work. Talk to your doctor about risks and benefits.

Study Details

Study typeFda approval

PublishedNov 2011

View Original Abstract ↓

1 INDICATIONS AND USAGE JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. ( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. ( 1.4 ) 1.1 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. 1.2 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. 1.3 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. 1.4 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.

FDA approved Jakafi (ruxolitinib) for Steroid-Refractory Acute Graft-Versus-Host DiseaseFDA approved Jakafi for acute graft-versus-host disease in patients 12 and older.

Study Details

Biomarkers and clinical factors show statistical associations with sepsis-induced coagulopathy in 37,459 patients

Your Blood May Signal a Deadly Clotting Crisis Before It Strikes

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FDA approved Jakafi (ruxolitinib) for Steroid-Refractory Acute Graft-Versus-Host DiseaseFDA approved Jakafi for acute graft-versus-host disease in patients 12 and older.

Study Details

Biomarkers and clinical factors show statistical associations with sepsis-induced coagulopathy in 37,459 patients

Your Blood May Signal a Deadly Clotting Crisis Before It Strikes

Clinical research that matters. Delivered to your inbox.

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