Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about XALKORI.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking XALKORI
against the benefits it is expected to
have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What XALKORI is
XALKORI is used to treat rare types
of lung cancer caused by defects in a
gene called anaplastic lymphoma
kinase (ALK) or a gene called ROS1.
XALKORI may slow or stop the
growth of these types of lung cancer.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it
for another reason.
XALKORI is only available with a
It is not addictive.
Use in Children
The safety and efficacy of
XALKORI in children have not been
Before you take
When you must not take it
Do not take XALKORI if you have
an allergy to:
crizotinib (the active ingredient in
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue
or other parts of the body
rash, itching or hives on the skin
Do not take XALKORI after the
expiry date printed on the pack or
if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged, return
it to your pharmacist for disposal.
Before you start to take it
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you have or
have ever had any of the following
any other lung problems
problems with your heart rate or
heart rhythm, including
prolonged QT interval
inflammation of the
cancer that has spread to the
stomach or intestines
Tell your doctor if you are
pregnant, plan to become pregnant
or plan to father a child.
XALKORI may affect the
Tell your doctor if you are breast-
You should not breastfeed if you are
being treated with XALKORI.
If you are not sure whether you
should start taking this medicine,
talk to your doctor.
Taking other medicines
Tell your doctor or pharmacist if
you are taking any other
all prescription medicines
all medicines, vitamins, herbal
supplements or natural therapies
you buy without a prescription
from a pharmacy, supermarket,
naturopath or health food shop.
Some medicines may be affected by
XALKORI or may affect how well it
Tell your doctor or pharmacist if
you are taking any of the following
itraconazole, ketoconazole or
voriconazole, medicines to treat
atazanavir, efavirenz, indinavir,
ritonavir or saquinavir, medicines
to treat HIV infection/AIDS
moxifloxacin or ciprofloxacin,
medicines to treat bacterial
carbamazepine, phenobarbital or
phenytoin, medicines to treat
epilepsy, seizures or fits
rifabutin or rifampicin, medicines
to treat tuberculosis and some
St. John's wort, a herbal medicine
to treat anxiety or depression
ergotamine, a medicine to treat
migraine and some other types of
droperidol, haloperidol or
ziprasidone, medicines to treat
imipramine or other medicines to
midazolam, a medicine used for
sedation or to cause sleepiness
alfentanil, fentanyl or methadone,
medicines to treat pain
ciclosporin, sirolimus or
tacrolimus, medicines used in
amiodarone, digoxin, diltiazem,
bisoprolol, carvedilol or sotalol,
medicines to treat heart problems
and/or high blood pressure
clonidine, atenolol, labetalol,
oxprenolol, pindolol or
propranolol, medicines to treat
high blood pressure and/or other
colchicine, a medicine to treat
dabigatran, a medicine to prevent
bupropion, a medicine to help
people stop smoking
pravastatin, a medicine to treat
metformin, a medicine to treat
mefloquine or quinine, medicines
to prevent or treat malaria
You may need to take different
amounts of your medicines or you
may need to use different medicines.
Your doctor will advise you.
How to take XALKORI
Follow all directions given to you
by your doctor or pharmacist
They may differ from the
information contained in this leaflet.
If you do not understand the
instructions, ask your doctor or
pharmacist for help.
How much to take
Your doctor will tell you how many
capsules you need to take each day.
This may depend on your condition
and whether you are taking any other
The usual dose of XALKORI is one
capsule of 250 mg taken twice a day.
Your doctor may change your dose
How to take it
Swallow the capsule whole with a
glass of water.
When to take it
Take the capsules at about the
same time each day.
If your doctor has told you to take
the capsules twice a day, take one
capsule in the morning and one
capsule in the evening, about
12 hours apart.
Taking them at the same time each
day will help you to remember when
to take them.
It does not matter if you take
XALKORI before or after food.
If you vomit after taking a dose of
XALKORI, do not take an extra
dose, just take your next dose at the
How long to take it
Continue taking XALKORI for as
long as your doctor tells you.
If you forget to take it
If it is less than 6 hours before your
next dose, skip the dose you missed
and take your next dose when you
are meant to.
Otherwise, take it as soon as you
remember, and then go back to
taking XALKORI as you would
Do not take a double dose to make
up for the dose that you missed.
This may increase the chance of you
getting an unwanted side effect.
If you are not sure what to do, ask
your doctor or pharmacist.
If you take too much
Immediately telephone your doctor
or Poisons Information Centre
(Phone 13 11 26) for advice or go to
Accident and Emergency at the
nearest hospital, if you think you
or anyone else may have taken too
Do this even if there are no signs of
discomfort or poisoning.
While you are using
Things you must do
Make sure you follow your
doctor's instructions and keep all
Your doctor will check your
progress. You will also have blood
tests and other tests to check for side
Tell your doctor immediately if
you or your partner become
pregnant while taking XALKORI.
Use contraception (birth control)
to prevent pregnancy while you are
being treated with XALKORI.
Women who could become pregnant
or men who could father a child must
use a reliable method of
contraception during treatment with
XALKORI and for at least 90 days
after taking the last dose.
If you are going to have surgery,
tell the surgeon or anaesthetist that
you are taking this medicine.
It may affect other medicines used
Tell any doctor, dentist or
pharmacist who treats you that
you are taking XALKORI.
If you are about to be started on
any new medicine, remind your
doctor and pharmacist that you
are taking XALKORI.
Things you must not do
Do not take XALKORI to treat
any other complaints unless your
doctor tells you to.
Do not give XALKORI to anyone
else, even if their condition seems
similar to yours.
Do not stop taking XALKORI or
change the dosage without
checking with your doctor.
Things to be careful of
Avoid eating grapefruit or
drinking grapefruit juice while you
are being treated with XALKORI.
Grapefruit and grapefruit juice may
change the amount of XALKORI in
Be careful driving or operating
machinery until you know how
XALKORI affects you.
XALKORI may cause dizziness and
tiredness and changes in vision in
some people. If you have any of
these symptoms, do not drive,
operate machinery or do anything
else that could be dangerous.
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are taking
All medicines can have side effects.
Sometimes they are serious, most of
the time they are not. You may need
medical attention if you get some of
the side effects.
It can be difficult to tell whether side
effects are the result of taking
XALKORI, effects of your condition
or side effects of other medicines you
may be taking. For this reason it is
important to tell your doctor of any
change in your condition.
Medicines can affect people in
Ask your doctor or pharmacist to
answer any questions you may
Do not be alarmed by the list of
possible side effects.
You may not experience any of them.
Tell your doctor or pharmacist if
you notice any of the following:
blurred vision, flashes of light,
floaters in eye, double vision
nausea (feeling sick) or vomiting
swelling of hands, feet or legs
loss of appetite
tingling or numbness of hands or
feet; pins and needles
change in sense of taste
soreness or redness of mouth, lips
slow heart rate
pain in back, side or upper
heartburn, belching, indigestion
reduced sex drive in men,
difficulty in getting an erection
Tell your doctor immediately or go
to Accident and Emergency at
your nearest hospital, if you notice
any of the following:
difficulty breathing, shortness of
breath, cough, coughing up
pinkish mucus or blood, rapid
weight gain, fluid retention,
dizziness, fainting, chest pain,
rapid or irregular heartbeat
pain on right side of stomach,
feeling more tired than usual,
weakness, dark urine, itchy skin,
yellowing of the skin or eyes,
bleeding or bruising more easily
severe stomach pain
loss of vision
The above side effects may be
serious. You may need urgent
Tell your doctor if you notice
anything else that is making you
Other side effects not listed above
may also occur in some patients.
Some side effects might only be
found when your doctor does blood
tests or other tests. These tests could
show a change in the liver, kidney,
levels of blood cells or changes in
After using XALKORI
Keep XALKORI capsules in the
original container until it is time to
Store XALKORI in a cool dry
place where the temperature stays
Do not leave XALKORI or any
other medicine in the car or on
Do not store XALKORI or any
other medicine in the bathroom or
near a sink.
Heat and dampness can destroy some
Keep the capsules where children
cannot reach them.
A locked cupboard at least one-and-
a-half metres above the ground is a
good place to store medicines.
If your doctor tells you to stop
taking this medicine or the expiry
date has passed, ask your
pharmacist what to do with any
capsules that are left over.
What it looks like
XALKORI 200 mg capsules have a
pink cap and white body and are
printed with "Pfizer" on the cap and
"CRZ 200" on the body in black ink.
XALKORI 250 mg capsules have a
pink cap and body and are printed
with "Pfizer" on the cap and "CRZ
250" on the body in black ink.
XALKORI is supplied in blister
packs containing 60 capsules.
XALKORI capsules contain 200 mg
or 250 mg of crizotinib as the active
The capsules also contain:
calcium hydrogen phosphate
sodium starch glycollate
colloidal anhydrous silica
titanium dioxide (E171)
red iron oxide (E172)
XALKORI capsules do not contain
lactose, sucrose, gluten, tartrazine or
any other azo dyes.
XALKORI is supplied in Australia
Pfizer Australia Pty Ltd
Toll Free number: 1800 675 229
XALKORI 200 mg:
AUST R 190964 (blister pack)
XALKORI 250 mg:
AUST R 190965 (blister pack)
Date of preparation
This leaflet was prepared in April
® = Registered Trademark
© Pfizer Australia Pty Ltd