What is the most important
information I should know about TURALIO® (pexidartinib)?
TURALIO can cause serious side effects, including
serious liver problems, which may be severe and can lead to death.
Your healthcare provider will do blood tests to check for liver
problems:
- before starting treatment with TURALIO
- every week for the first 8 weeks during treatment
- every 2 weeks for the next month
- then every 3 months after that
If you develop liver problems during treatment with TURALIO, your
healthcare provider may do blood tests more often to monitor you. It is
important to stay under the care of your healthcare provider during treatment
with TURALIO.
Stop taking TURALIO and call your healthcare provider right away if
you develop yellowing of your skin and whites of your eyes or dark urine.
Tell your healthcare provider right away if you have any of these
symptoms of liver problems while taking TURALIO: lack or loss of appetite, right
upper stomach-area (abdomen) pain or tenderness, feeling overly tired, nausea,
vomiting, fever, rash, or itching.
TURALIO Risk Evaluation and Mitigation
Strategy (REMS):
Because of the risk of serious liver problems,
TURALIO is available only through a restricted program called the TURALIO REMS
Program. Your healthcare provider must be enrolled in the program in order for
you to be prescribed TURALIO. There is a registry that collects information
about the effects of taking TURALIO over time. You must complete and sign an
enrollment form for the TURALIO REMS Program and the registry. Ask your
healthcare provider for more information.
See “What are the possible side effects of TURALIO?” for
more information about side effects.
What is TURALIO?
TURALIO is a prescription medicine used to treat certain adults
who have tenosynovial giant cell tumor (TGCT) that is not likely to improve with
surgery. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or
pigmented villonodular synovitis (PVNS).
It is not known if TURALIO is safe and effective in children.
Before you take TURALIO, tell your
healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider
about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal
supplements. Certain medicines may affect the way TURALIO works and TURALIO may
affect how other medicines work.
Taking TURALIO with
certain medicines may
increase the amount of TURALIO in your blood. This may make it more likely
for
you to have side effects and may cause more severe side effects.
-
Avoid taking the following medicines during treatment with TURALIO because
they can affect how TURALIO works: proton pump inhibitor medicines (PPIs);
St. John’s wort.
How should I take TURALIO?
What should I avoid while taking
TURALIO?
-
Avoid grapefruit or drinking grapefruit juice during treatment with TURALIO.
Grapefruit or grapefruit juice can cause you to have too much TURALIO in
your blood and may lead to increased side effects and more severe side
effects.
What are the possible side effects of
TURALIO?
TURALIO can cause serious side effects.
See “What is the most important information I should
know about TURALIO?”
There are possible risks if TURALIO is taken with a high-fat
meal. Avoid taking TURALIO with a high-fat meal (about 55 to 65 grams of total
fat).
Taking TURALIO with a high-fat meal increases the amount of medicine in
your blood. This may make it more likely for you to develop side effects and may
cause more severe side effects, including serious liver problems.
Take TURALIO
with a low-fat meal (about 11 to 14 grams of total fat). See “How should I take
TURALIO?”
The most common side effects of TURALIO include: changes in blood liver tests; hair color changes; tiredness; increased cholesterol level in the blood; decreased white blood cells and red blood cells; swelling in and around your eyes; rash, itching, hives, skin redness, and acne; loss of taste or changes in the way things taste, and decreased phosphate in your blood.
- TURALIO may affect fertility in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all of the possible side effects of TURALIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
General information about the safe and effective use of TURALIO
Do not give TURALIO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider for more information.
Please
click here for Full Prescribing Information, including Boxed WARNING, and
click here for Medication Guide.
