JAKAFI®/JAKAFI XR™ (ruxolitinib)  - Incyte Corporation


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Indications & Usage

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.
  • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.

Dosage & Administration

DOSAGE AND ADMINISTRATION

Doses should be individualized based on safety and efficacy. Starting doses per indication are noted below.

Myelofibrosis

  • The starting dose of JAKAFI/JAKAFI XR is based on patient’s baseline platelet count:
    • Greater than 200 × 109/L: JAKAFI 20 mg given orally twice daily or JAKAFI XR 44 mg given orally once daily.
    • 100 × 109/L to 200 × 109/L: JAKAFI 15 mg given orally twice daily or JAKAFI XR 33 mg given orally once daily.
    • 50 × 109/L to less than 100 × 109/L: JAKAFI 5 mg given orally twice daily or JAKAFI XR 11 mg given orally once daily.

Polycythemia Vera

  • The starting dose of JAKAFI is 10 mg given orally twice daily or JAKAFI XR 22 mg given orally once daily.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.

Dosage Forms & Strengths

DOSAGE FORMS AND STRENGTHS

JAKAFI tablets: 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.

JAKAFI XR extended-release tablets: 11 mg, 22 mg, 33 mg, 44 mg and 55 mg.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.

Contraindications

CONTRAINDICATIONS

None.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.

Warnings & Precautions

WARNINGS AND PRECAUTIONS

  • Thrombocytopenia, Anemia, and Neutropenia: Manage by dose reduction or interruption, or transfusion.
  • Risk of Infection: Assess patients for signs and symptoms of infection and initiate appropriate treatment promptly. Serious infections should have resolved before starting therapy with JAKAFI/JAKAFI XR.
  • Symptom Exacerbation Following Interruption or Discontinuation: Manage with supportive care and consider resuming treatment with JAKAFI/JAKAFI XR.
  • Risk of Non-Melanoma Skin Cancer: Perform periodic skin examinations.
  • Lipid Elevations: Assess lipid levels 8 to 12 weeks from start of therapy and treat as needed.
  • Major Adverse Cardiovascular Events (MACE): Monitor for development of MACE.
  • Thrombosis: Evaluate and treat symptoms of thrombosis promptly.
  • Secondary Malignancies: Monitor for development of secondary malignancies, particularly in patients who are current or past smokers.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.

Adverse Reactions

ADVERSE REACTIONS

In myelofibrosis, the most common hematologic adverse reactions
(incidence >20%) were thrombocytopenia and anemia. The most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness and headache.  

In polycythemia vera, the most common hematologic adverse reactions (incidence >20%) were anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence ≥15%) were diarrhea and dizziness.

To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.

Drug Interactions

DRUG INTERACTIONS

  • Fluconazole: Avoid concomitant use with fluconazole doses greater than 200 mg. Reduce JAKAFI/JAKAFI XR dosage with fluconazole doses less than or equal to 200 mg.
  • Strong CYP3A4 Inhibitors: Reduce, interrupt, or discontinue JAKAFI/JAKAFI XR doses as recommended except in patients with acute or chronic graft-versus-host-disease.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.

Use in Specific Populations

 USE IN SPECIFIC POPULATIONS

  • Renal Impairment: Reduce JAKAFI/JAKAFI XR starting dose or avoid treatment as recommended.
  • Hepatic Impairment: Reduce JAKAFI/JAKAFI XR starting dose or avoid treatment as recommended.
  • Lactation: Advise not to breastfeed.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.

JAKAFI and the JAKAFI logo are registered trademarks of lncyte.
JAKAFI XR and the JAKAFI XR logo are trademarks of lncyte.
lncyte and the lncyte logo are registered trademarks of lncyte.
All other trademarks are the property of their respective owners.
© 2026, lncyte. JAK-1978 11/26 

Full Prescribing Information

 

PROFESSIONAL IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia, Anemia and Neutropenia

  • JAKAFI®/JAKAFI XR™ (ruxolitinib) can cause dose-related effects of thrombocytopenia, anemia and neutropenia. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.
  • Manage thrombocytopenia by reducing the dose or temporarily interrupting JAKAFI/JAKAFI XR. Platelet transfusions may be necessary.
  • Patients developing anemia may require blood transfusions and/or dose modifications of JAKAFI/JAKAFI XR.
  • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible by withholding JAKAFI/JAKAFI XR until recovery.

Risk of Infection

  • Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting JAKAFI/JAKAFI XR until active serious infections have resolved. Observe patients receiving JAKAFI/JAKAFI XR for signs and symptoms of infection and manage promptly.

Tuberculosis

  • Tuberculosis (TB) infection with JAKAFI/JAKAFI XR has been reported. Observe patients taking JAKAFI/JAKAFI XR for signs and symptoms of active TB and manage promptly. Prior to initiating, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting in patients with evidence of active or latent TB. Continuation during treatment of active TB should be based on the overall risk-benefit determination.

Progressive Multifocal Leukoencephalopathy

  • Progressive multifocal leukoencephalopathy (PML) has occurred with JAKAFI/JAKAFI XR treatment. If PML is suspected, stop JAKAFI/JAKAFI XR and evaluate.

Herpes Zoster and Herpes Simplex

  • Herpes zoster infection, reactivation and/or dissemination has been reported in patients receiving JAKAFI/JAKAFI XR. Advise patients about early signs and symptoms of herpes zoster and seek treatment. Monitor patients for the development of herpes simplex infections. If a patient develops evidence of dissemination of herpes simplex, consider interrupting treatment.

Hepatitis B

  • Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections.

Symptom Exacerbation Following Interruption or Discontinuation of Treatment

  • When discontinuing JAK-Inhibitors, including JAKAFI/JAKAFI XR, myeloproliferative neoplasm-related signs and symptoms may flare. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, disseminated intravascular coagulation (DIC), or multi-organ failure. If any of these occur after discontinuation or while tapering JAKAFI/JAKAFI XR, evaluate and treat any intercurrent illness and consider restarting or increasing the dose. Instruct patients not to interrupt or discontinue JAKAFI/JAKAFI XR without consulting their physician. When discontinuing or interrupting JAKAFI/JAKAFI XR for reasons other than life-threatening toxicities, consider gradual tapering rather than abrupt discontinuation.

Non-Melanoma Skin Cancer (NMSC)

  • NMSC including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations.

Lipid Elevations

  • Treatment with JAKAFI/JAKAFI XR has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters 8-12 weeks after initiation.

Major Adverse Cardiovascular Events (MACE)

  • Another JAK-inhibitor has increased the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and stroke (compared to those treated with TNF blockers), in patients with rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

Thrombosis

  • Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis (compared to those treated with TNF blockers), in patients with rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated. In patients with myelofibrosis (MF) and polycythemia vera (PV), the rates of thromboembolic events were similar in JAKAFI/JAKAFI XR and control treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately.

Secondary Malignancies

  • Another JAK-inhibitor has increased the risk of lymphoma and other malignancies, excluding NMSC (compared to those treated with TNF blockers), in patients with rheumatoid arthritis, a condition for which JAKAFI/JAKAFI XR is not indicated. Patients who are current or past smokers are at additional increased risk.

Adverse Reactions

  • In myelofibrosis, the most common hematologic adverse reactions (incidence >20%) were thrombocytopenia and anemia. The most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness and headache.
  • In polycythemia vera, the most common hematologic adverse reactions (incidence >20%) were anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence ≥15%) were diarrhea and dizziness.

Drug Interactions

  • Avoid concomitant use with fluconazole doses greater than 200 mg. Dose modifications may be required when administering fluconazole doses of 200 mg or less, or with strong CYP3A4 inhibitors, or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy.

Pregnancy

  • Use during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking JAKAFI/JAKAFI XR should not breastfeed during treatment and for 2 weeks after the final dose.

Please click here for Full Prescribing Information for JAKAFI/JAKAFI XR.