JAKAFI

Mean ruxolitinib maximal plasma concentration (C max ) and AUC increased proportionally over a single dose range of 5 mg to 200 mg (4 times the approved highest recommended total daily dosage of 25 mg twice daily). Mean ruxolitinib C max ranged from 205 nM to 7100 nM and AUC ranged from 862 nM*hr to 30700 nM*hr over a single dose range of 5 mg to 200 mg.

AbsorptionRuxolitinib achieves C max within 1 hour to 2 hours post-dose. Oral absorption of ruxolitinib is estimated to be at least 95%. Effec...

14.1 Myelofibrosis Two randomized Phase 3 studies (Studies 1 and 2) were conducted in patients with MF (either primary MF, post-polycythemia vera MF or post-essential thrombocythemia-MF). In both studies, patients had palpable splenomegaly at least 5 cm below the costal margin and risk category of intermediate 2 (2 prognostic factors) or high risk (3 or more prognostic factors) based on the International Working Group Consensus Criteria (IWG). The starting dose of Jakafi was based on platelet count. Patients with a platelet count between 100 and 200 x 10 9 /L were started on Jakafi 15 mg twice...

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions ( 5.1 )] Risk of Infection [see Warnings and Precautions ( 5.2 )] Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi [see Warnings and Precautions ( 5.3 )] Non-Melanoma Skin Cancer [see Warnings and Precautions ( 5.4 )] Lipid Elevations [ see Warnings and Precautions ( ...

None. None. ( 4 )

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 per...

7. DRUG INTERACTIONS Fluconazole: Avoid concomitant use with fluconazole doses greater than 200 mg. Reduce Jakafi dosage with fluconazole doses less than or equal to 200 mg. ( 2.6 , 7 ) Strong CYP3A4 Inhibitors: Reduce, interrupt, or discontinue Jakafi doses as recommended except in patients with acute or chronic graft-versus-host-disease. ( 2.6 , 7 ) 7.1 Effect of Other Drugs on Jakafi Fluconazol...