INDICATIONS AND USAGE

Myelofibrosis

Jakafi 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 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 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 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.

DOSAGE

Myelofibrosis

The recommended starting dose of Jakafi is based on platelet count. A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Doses may be titrated based on safety and efficacy.

Polycythemia Vera

The recommended starting dose of Jakafi is 10 mg twice daily. Doses may be titrated based on safety and efficacy.

Acute Graft-Versus-Host Disease

The recommended starting dose of Jakafi is 5 mg given orally twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with Jakafi.

Consider tapering Jakafi after 6 months of treatment in patients with response who have discontinued therapeutic doses of corticosteroids. Taper Jakafi by one dose level approximately every 8 weeks (10 mg twice daily to 5 mg twice daily to 5 mg once daily). If aGVHD signs or symptoms recur during or after the taper of Jakafi, consider retreatment.

Chronic Graft-Versus-Host Disease

The recommended starting dose of Jakafi is 10 mg given orally twice daily.

Consider tapering Jakafi after 6 months of treatment in patients with response who have discontinued therapeutic doses of corticosteroids. Taper Jakafi by one dose level approximately every 8 weeks (10 mg twice daily to 5 mg twice daily to 5 mg once daily). If GVHD signs or symptoms recur during or after the taper of Jakafi, consider retreatment.

ADVERSE REACTIONS

Thrombocytopenia, Anemia and Neutropenia

Risk of Infection

Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi

Non-Melanoma Skin Cancer

Lipid Elevations

Major Adverse Cardiovascular Events (MACE)

Thrombosis

Secondary Malignancies

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f1c82580-87ae-11e0-bc84-0002a5d5c51b/spl-doc?hl=Ruxolitinib

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