Important Safety
Information
What is the most important
information I should know about VANFLYTA® (quizartinib)?
VANFLYTA may cause serious side effects, including:
-
Changes in the electrical activity of your heart
called QT prolongation,
torsades de pointes, and your heart stopping (cardiac arrest).
QT
prolongation can cause irregular heartbeats that can be life-threatening
or
lead to death. Your healthcare provider will check the electrical
activity
of your heart with a test called an electrocardiogram (ECG) and will
also do
blood tests to check your potassium and magnesium levels before and
during
treatment with VANFLYTA. Tell your healthcare provider right away if you
have an irregular heartbeat or feel dizzy, lightheaded, or faint, or
have
diarrhea or vomiting.
VANFLYTA is available only through a
restricted program called the VANFLYTA Risk
Evaluation and Mitigation Strategy (REMS) due to the risk of QT prolongation,
torsades de pointes, and cardiac arrest.
You will receive a VANFLYTA Patient Wallet
Card from your healthcare provider. Carry the VANFLYTA
Patient Wallet Card with
you at all times and show it to all of your healthcare providers. The
VANFLYTA
Patient Wallet Card lists signs and symptoms of QT prolongation and torsades de
pointes.
Get medical help right away if you develop
any of the signs and symptoms listed
on the VANFLYTA Patient Wallet Card. You may need
to be treated in a hospital.
See “What are
the possible side effects of VANFLYTA?” for more information about
side effects.
What is VANFLYTA?
VANFLYTA is a prescription medicine used
in combination with certain chemotherapy
medicines and alone as
maintenance therapy to treat adults with newly diagnosed acute myeloid leukemia
(AML) with a FLT3-ITD mutation.
Your healthcare provider will perform a
test to make sure that VANFLYTA is right for you.
VANFLYTA is not for use alone as
maintenance therapy after a hematopoietic stem cell transplant.
It is not known if VANFLYTA is safe and
effective in children.
Who should not take VANFLYTA?
Do not take VANFLYTA if you have very low potassium, very low magnesium, long QT
syndrome, or a history of ventricular arrhythmias or torsades de
pointes.
Before you take VANFLYTA, tell your
healthcare provider about all of your medical conditions, including if you:
- have any heart problems.
- have low blood levels of potassium or magnesium.
- are pregnant or plan to become pregnant. VANFLYTA can harm
your unborn baby. Tell your healthcare provider right away if you become
pregnant or think you may be pregnant during treatment with VANFLYTA.
- If you are able to become pregnant, your healthcare provider will
perform a pregnancy test within 7 days before you start treatment with
VANFLYTA.
- Females who are able to become pregnant
should use effective birth control (contraception) during treatment with
VANFLYTA and for 7 months after the last dose of VANFLYTA.
- Males who have female partners who are
able to become pregnant should use effective birth control during
treatment with VANFLYTA and for 4 months after the last dose of
VANFLYTA.
- Talk to your healthcare provider about birth control methods you can use
during this time.
- are breastfeeding or plan to breastfeed. It is not known if VANFLYTA passes
into your breast milk. Do not breastfeed during treatment with VANFLYTA and
for 1 month after the last dose of VANFLYTA.
Tell your
healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
VANFLYTA and other medicines may affect each other causing side effects.
Especially tell your healthcare provider
if you take St. John’s wort. You should
not take St. John’s wort during treatment with VANFLYTA.
What are the possible side
effects
of VANFLYTA?
VANFLYTA may cause serious side effects, including:
- See “What is the most important
information I should know about VANFLYTA?”
The most common side effects of VANFLYTA
include:
- low white blood cell counts
- changes in levels of electrolytes in the blood
- changes in liver function tests
- low white blood cell counts with fever
- diarrhea
- mouth sores
- nausea
- stomach (abdominal) pain
- serious infection throughout the body and organs (sepsis)
- headache
- vomiting
- upper respiratory tract infections
- low platelet counts
- decreased appetite
- fungal infections
- nosebleed
- herpesvirus infections
- trouble sleeping
- abnormal electrocardiogram (QT prolongation)
- upset stomach
- low red blood cell counts (anemia)
- eye irritation
Your healthcare provider will do blood
tests and ECGs before you start and during
treatment with VANFLYTA. Your healthcare provider may tell you to decrease your
dose, temporarily stop, or permanently stop taking VANFLYTA if you develop certain side
effects during treatment with VANFLYTA.
VANFLYTA may cause fertility problems
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 the possible side
effects of VANFLYTA. Call your doctor for
medical advice about side effects. You may report side effects to the FDA at
1-800-FDA-1088.
How should I take VANFLYTA?
- Take VANFLYTA exactly as your healthcare provider
tells you to. Do not
change your dose or stop taking VANFLYTA unless your healthcare provider
tells you to.
- Take VANFLYTA by mouth 1 time a day at about the same time each day.
- Take VANFLYTA with or without food.
- Swallow VANFLYTA tablets whole. Do not cut, crush, or chew the tablets.
- If you miss a dose of VANFLYTA or did not take it at your usual time, take
your dose as soon as possible on the
same day. Take your next dose at your usual time on the next day. Do not
take 2 doses on the same day to
make up for a missed dose.
- If you vomit after taking a dose of VANFLYTA, do not take another dose. Take
your next dose at your usual time the next day.
