FDA Approved for Polycythemia Vera and Myelofibrosis
In December 2014, the U.S. Food and Drug Administration (FDA) approved Jakafi for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to, or are intolerant of hydroxyurea (HU). This approval was based upon results of the Phase III RESPONSE trial and resulted in several updates to the prescribing information (PI). The most recent version of the Prescribing Information is available here.
Jakafi was approved in 2011 for the treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.
In depth information on Jakafi (ruxolitinib) can be found on the manufacturer’s comprehensive website.
IMPORTANT SAFETY INFORMATION
• Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia, which are each dose‐related effects. 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
• Manage thrombocytopenia 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 10%) were bruising, dizziness and headache
• A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or fluconazole 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