Incyte announced that the FDA has updated prescribing information for Jakafi (ruxolitinib) tablets to include new recommended dosing guidance for patients with low platelet counts as well as additional safety information.

Jakafi is a JAK1 and JAK2 inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.

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The update recommends a new starting dose of 5mg twice daily for patients with baseline platelet counts 50–90 x 109/L (50,000–100,000). In addition, the update includes options for subsequent dose modifications based on safety and efficacy.

The FDA approved this dosing update based on a supplemental New Drug Application (sNDA), which included data from an ongoing Phase 2 study (Study 258) of patients with baseline platelet counts of 50,000–100,000. The safety and efficacy data were general consistent with the results from the Phase 3 COMFORT-I and COMFORT-II program.

In addition, new safety information has been added to the Warnings and Precautions section that states: “Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate.”

The Patient Counseling Information section has also been updated to advise healthcare professionals to inform patients about the early signs and symptoms of PML.

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