If you are unable to see the message below, click here to view   Incyte.com >     Jakafi.com >     Updated Jakafi PI >       Updated Prescribing Information for Jakafi® (ruxolitinib) With Expanded Dosing Guidance and Safety Information   Dear Dr (Last Name), Incyte Corporation recently announced that the US Food and Drug Administration (FDA) has approved expanded dosing guidance for Jakafi for the treatment of intermediate or high-risk myelofibrosis patients with low starting platelet counts. Approved in November 2011, Jakafi is the only FDA-approved product for the treatment of intermediate or high-risk myelofibrosis. The new recommended starting dose of Jakafi for patients starting treatment who have platelet counts between 50 to less than 100 × 109/L is now 5 mg twice daily. The revised prescribing information also provides guidance for dose changes for patients with low starting platelet counts based on safety and efficacy. Dosing may be reduced or temporarily interrupted based on platelet or neutrophil counts. Additionally, dosing may be increased up to a maximum dose of 10 mg twice daily to achieve desired responses in patients starting treatment who have low platelet counts. This new dosing information augments the recommended dosing guidance previously described in the prescribing information for patients starting treatment who have platelet counts >100 × 109/L. Jakafi should be avoided in patients with end stage renal disease not requiring dialysis or in patients with (1) moderate or severe renal impairment, hepatic impairment or concomitant use of strong CYP3A4 inhibitors and (2) platelet counts <100 × 109/L. Additional safety information was also added to the Warnings and Precautions section of the package insert, stating that progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate. This label change is based on one known case of PML in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product. Additionally, there have been some updates to the patient counseling section that should be discussed with patients prior to treatment with Jakafi. For additional details regarding these label changes, please see the accompanying full prescribing information for Jakafi, also available at Incyte.com. Indications and Usage Jakafi is indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis and post–essential thrombocythemia myelofibrosis. Important Safety Information • Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated   • Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary   • Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi   • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible. Withhold Jakafi until recovery   • The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache   • Serious bacterial, mycobacterial, fungal and viral infections may occur. Active serious infections should have resolved before starting Jakafi. Observe patients receiving Jakafi for signs and symptoms of infection and initiate appropriate treatment promptly. Advise patients about early signs and symptoms of herpes zoster and to seek early treatment   • Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate   • A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy   • Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breast-feed   Please see Full Prescribing Information for Jakafi.         Jakafi is a registered trademark of Incyte Corporation. © 2013, Incyte Corporation. All rights reserved.   RUX-1230    06/13       If you no longer wish to receive email communications from Incyte, please unsubscribe. You can also opt out of communications by sending a request to: Incyte Corporation P.O. Box 4689 Trenton, NJ 08650 Replies to the email address do-not-reply@incyte.com will not be processed. For more information, please contact us at 1-855-4-Jakafi (855-452-5234).