ASH Clinical News August 2017 v3 | Page 40
In the treatment of patients with intermediate or high-risk myelofibrosis
CHANGE WHAT'S AHEAD
INTERVENE WITH JAKAFI
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. 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
Serious bacterial, mycobacterial, fungal and viral infections have
occurred. Delay starting Jakafi until active serious infections
have resolved. Observe patients receiving Jakafi for signs and
symptoms of infection and manage promptly
Tuberculosis (TB) infection has been reported. Observe patients
taking Jakafi for signs and symptoms of active TB and manage
promptly. Prior to initiating Jakafi, evaluate patients for TB risk
factors and test those at higher risk for latent infection. Consult
a physician with expertise in the treatment of TB before starting
Jakafi in patients with evidence of active or latent TB. Continuation
of Jakafi during treatment of active TB should be based on the
overall risk-benefit determination
Patients developing anemia may require blood transfusions and/or
dose modifications of Jakafi Progressive multifocal leukoencephalopathy (PML) has occurred
with ruxolitinib treatment for myelofibrosis. If PML is suspected,
stop Jakafi and evaluate
Severe neutropenia (ANC <0.5 × 10 9 /L) was generally reversible by
withholding Jakafi until recovery Advise patients about early signs and symptoms of herpes zoster
and to seek early treatment
Jakafi is a registered trademark of Incyte Corporation.
© 2016, Incyte Corporation. All rights reserved. RUX-1786c 05/16
Increases in hepatitis B viral load with or without associated
elevations in alanine aminotransferase and aspartate
aminotransferase have been reported in patients with chronic
hepatitis B virus (HBV) infections. Monitor and treat patients with
chronic HBV infection according to clinical guidelines