ASH Clinical News February 2015 | Page 12

Introducing the first and
FDA-approved treatment

patients with polycythemia vera
an inadequate response to or are
In a phase 3 trial of Jakafi® (ruxolitinib) vs best available therapy:
21% of patients receiving Jakafi achieved the primary composite end point
of hematocrit (Hct) control and spleen volume reduction compared with <1%
of patients on best available therapy at week 32 (P < 0.0001)*

Indications and Usage
Jakafi is indicated for treatment of patients with
polycythemia vera who have had an inadequate
response to or are intolerant of hydroxyurea.

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
tr ansfusions and/or dose modifications of Jakafi
Severe neutropenia (ANC <0.5 X 109/L) was generally
reversible by withholding Jakafi until recovery
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
Progressive multifocal leukoencephalopathy (PML)
has occurred with ruxolitinib treatment for
myelofibrosis. If PML is suspected, stop Jakafi
and evaluate
Advise patients about early signs and symptoms
of herpes zoster and to seek early treatment
When discontinuing Jakafi, myeloproliferative
neoplasm-related symptoms may return within one
week. After discontinuation, some patients with
myelofibrosis have experienced fever, respiratory
distress, hypotension, DIC, or multi‐organ failure.
If any of these occur after discontinuation or while
tapering Jakafi, evaluate and treat any intercurrent

Jakafi is a registered trademark of Incyte Corporation.
© 2014, Incyte Corporation. All rights reserved. RUX-1451 12/14