Indications and Usage (1.2)     12/2014
Dosage and Administration (2.2), (2.3), (2.4)     12/2014
Warnings and Precautions (5.2), (5.3), (5.4)     12/2014

Jakafi is a kinase inhibitor indicated for treatment of patients with:

• intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. (1.1)
• polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. (1.2)

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

Myelofibrosis (2.1)

• The starting dose of Jakafi is based on patient’s baseline platelet count:
    •  Greater than 200 X 109/L: 20 mg given orally twice daily
    •  100 X 109/L to 200 X 109/L: 15 mg given orally twice daily
    •  50 X 109/L to less than 100 X 109/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 (2.2)

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

Tablets: 5 mg, 10 mg, 15 mg, 20 mg and 25 mg. (3)
CONTRAINDICATIONS

None. (4)
WARNINGS AND PRECAUTIONS

• Thrombocytopenia, Anemia and Neutropenia: Manage by dose reduction, or interruption, or transfusion. (5.1)
• 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. (5.2)
• Symptom Exacerbation Following Interruption or Discontinuation: Manage with supportive care and consider resuming treatment with Jakafi. (5.3)
• Risk of Non-Melanoma Skin Cancer (5.4)

The most common hematologic adverse reactions (incidence > 20%) are thrombocytopenia and anemia. The most common non-hematologic adverse reactions (incidence >10%) are bruising, dizziness and headache. (6.1)

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

• Strong CYP3A4 Inhibitors or Fluconazole: Reduce, interrupt, or discontinue Jakafi doses as recommended. (2.3) (7.1) Avoid use of Jakafi with fluconazole doses greater than 200 mg.

• Renal Impairment: Reduce Jakafi starting dose or avoid treatment as recommended. (2.4) (8.6)
• Hepatic Impairment: Reduce Jakafi starting dose or avoid treatment as recommended. (2.4) (8.7)
• Nursing Mothers: Discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother. (8.3)