Rx Item-Jakafi 15mg Tablets 1X60 Each By yte Pharma

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JAKAFI safely and effectively. See full prescribing information for JAKAFI. JAKAFI� (ruxolitinib) tablets, for oral use Initial U.S. Approval: 2011 RECENT MAJOR CHANGES Warnings and Precautions (5.2) 10/2017 INDICATIONS AND USAGE 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) DOSAGE AND ADMINISTRATION 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. DOSAGE FORMS AND STRENGTHS 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: Perform periodic skin examinations. (5.4) Lipid Elevations: Assess lipid levels 8-12 weeks from start of therapy and treat as needed. (5.5) ADVERSE REACTIONS 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 DRUG INTERACTIONS Strong CYP3A4 Inhibitors or Fluconazole: Reduce, interrupt, or discontinue Jakafi doses as recommended. Avoid use of Jakafi with fluconazole doses greater than 200 mg. (2.3) (7) USE IN SPECIFIC POPULATIONS 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) Lactation: Advise not to breastfeed. (8.2) See 17 for FDA-approved patient labeling. Revised: 1/2019

JAKAFI 15MG TABLETS 1X60 EACH
NDC No.50881-0015-60 50881-015-60
UPC/GTIN No..3-50881-01560-1 MPN 560 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, Pha

JAKAFI 15MG TABLETS 1X60 EACH
JAKAFI 15MG TABLETS 1X60 EACH BY INCYTE PHARMA Generic Name: RUXOLITINIB Description: JAKAFI, 15MG, (900 MG), TABLETS, 1X60 EA NDC: 50881-0015-60 UPC: 350881-015601

JAKAFI 15MG TABLETS 1X60 EACH
JAKAFI 15MG TABLETS 1X60 EACH BY INCYTE PHARMA Generic Name: RUXOLITINIB Description: JAKAFI, 15MG, (900 MG), TABLETS, 1X60 EA NDC: 50881-0015-60 UPC: 350881-015601

JAKAFI 5MG TABLETS
JAKAFI 5MG TABLETS Generic Name: RUXOLITINIB Description: JAKAFI, 5MG, (300000 MCG), TABLETS, 1X60 EA NDC: 50881-0005-60 UPC: 350881-005602

JAKAFI 15MG TABLETS 1X60 EACH
JAKAFI 15MG TABLETS 1X60 EACH BY INCYTE PHARMA Generic Name: RUXOLITINIB Description: JAKAFI, 15MG, (900 MG), TABLETS, 1X60 EA NDC: 50881-0015-60 UPC: 350881-015601

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