Summary of Important Information
Please read this summary carefully and
then talk with your healthcare provider
about Jakafi (JAK-ah-fye).
No advertisement can provide all the
information needed to determine if a drug
is right for you or take the place of careful
discussions with your healthcare provider.
Only your healthcare provider has the
training to weigh the risks and benefits
of a prescription drug.
What is Jakafi?
Jakafi is a prescription medicine used
to treat certain types of myelofibrosis.
Jakafi is also used to treat people with
polycythemia vera who have already
taken a medicine called hydroxyurea
and it did not work well enough or
they could not tolerate it.
It is not known if Jakafi is safe or
effective in children.
What should I tell my healthcare
provider before taking Jakafi?
Before taking Jakafi, tell your healthcare
provider if you:
• have an infection
• have or had tuberculosis (TB),
or have been in close contact with
someone who has TB
• have or had hepatitis B
• have or have had liver problems
• have or have had kidney problems
or are on dialysis. If you are on
dialysis, Jakafi should be taken
after your dialysis
• have had skin cancer in the past
• have any other medical conditions
• are pregnant or plan to become pregnant.
It is not known if Jakafi will harm your
• are breastfeeding or plan to breastfeed.
It is not known if Jakafi passes into
your breast milk. You and your
healthcare provider should decide
if you will take Jakafi or breastfeed.
You should not do both.
Tell your healthcare provider about all the
medicines you take, including prescription
and over-the-counter medicines, vitamins
and herbal supplements. Taking Jakafi with
certain other medicines may affect how
Jakafi works. Especially tell your healthcare
provider if you take medicine for:
• Fungal infections
• Bacterial infections
Ask your healthcare provider or
pharmacist if you are not sure if
your medicine is one listed above.
Know the medicines you take. Keep
a list of them to show your healthcare
provider and pharmacist when you
get a new medicine.
How should I take Jakafi?
• Take Jakafi exactly as your healthcare
provider tells you.
• Do not change your dose or stop
taking Jakafi without first talking
to your healthcare provider.
• You can take Jakafi with or without food.
• Jakafi may also be given through certain
° Tell your healthcare provider if you
cannot take Jakafi by mouth. Your
healthcare provider will decide if
you can take Jakafi through a
° Ask your healthcare provider to give you
specific instruction on how to properly
take Jakafi through a nasogastric tube.
• Do not drink grapefruit juice while taking
Jakafi. Grapefruit juice can affect the
amount of Jakafi in your blood.
• If you take too much Jakafi call your
healthcare provider or go to the nearest
hospital emergency room right away. Take
the bottle of Jakafi with you.
• If you miss a dose of Jakafi, take your next
dose at your regular time. Do not take 2
doses at the same time.
• You will have regular blood tests
during your treatment with Jakafi. Your
healthcare provider may change your dose
of Jakafi or stop your treatment based on
the results of your blood tests.
What are the possible
side effects of Jakafi?
Jakafi can cause serious side
Low blood cell counts. Jakafi may cause
low platelet counts (thrombocytopenia),
low red blood cell counts (anemia), and low
white blood cell counts (neutropenia). If
you develop bleeding, stop Jakafi and call
your healthcare provider. Your healthcare
provider will do a blood test to check your
blood cell counts before you start Jakafi and
regularly during your treatment with Jakafi.
Tell your healthcare provider right away if
you develop or have worsening of any of
• unusual bleeding • shortness of breath
• bruising • fever
Infection. You may be at risk for developing
a serious infection during treatment with
Jakafi. Tell your healthcare provider if you
develop any of the following symptoms
• chills • vomiting
• aches • weakness
• fever • painful skin rash or blisters
Skin cancers. Some people who take
Jakafi have developed certain types of
non-melanoma skin cancers. Tell your
healthcare provider if you develop any
new or changing skin lesions during
treatment with Jakafi.
Cholesterol increases. You may have
changes in your blood cholesterol levels.
Your healthcare provider will do blood tests
to check your cholesterol levels during
treatment with Jakafi.
The most common side effects of
• low platelet count (thrombocytopenia)
• low red blood cell counts (anemia)
Tell your healthcare provider about any
side effect that bothers you or that does
not go away.
These are not all the possible side effects
of Jakafi. Ask your healthcare provider or
pharmacist for more information.
Call your healthcare provider for medical
advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Incyte
Medical Information at 1-855-463-3463.
The risk information provided here is not
comprehensive. To learn more, talk about
Jakafi with your healthcare provider or
pharmacist. The FDA-approved product
labeling can be found at www.jakafi.com.
Wilmington, DE 19803
Revised: March 2016 RUX-1776
Jakafi is a registered trademark of Incyte.
U.S. Patent Nos. 7598257; 8415362;
8722693; 8822481; 8829013; 9079912
© 2011-2016 Incyte Corporation.
All rights reserved.