Ruxolitinib

INDICATIONS AND USAGE

Jakafi 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.

Steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

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 is based on patient’s baseline platelet count:
• Greater than 200 × 10%/L: 20 mg given orally twice daily
• 100 × 10%/L to 200 x 10%/L: 15 mg given orally twice daily
• 50 × 10%L to less than 100 × 10%/L: 5 mg given orally twice daily
• Monitor complete blood counts every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Modify or interrupt dosing for thrombocytopenia.

Polycythemia Vera

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

Acute Graft-Versus-Host Disease

The starting dose of Jakafi is 5 mg given orally twice daily.

Chronic Graft-Versus-Host Disease

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

DOSAGE FORMS AND STRENGTHS

Tablets: 5mgx60 tablets, 20mgx60 tablets