Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using SPRYCEL?
SPRYCEL contains the active ingredient dasatinib. SPRYCEL is used to treat adults
and children ages 12 months and older with chronic myeloid leukaemia (CML). It is
also used to treat adults and children ages 12 months and older who have a particular
form of acute lymphoblastic leukaemia (ALL) called Philadelphia chromosome positive
or Ph+ ALL.
2. What should I know before I use SPRYCEL?
Do not use if you have ever had an allergic reaction to dasatinib or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with SPRYCEL and affect how it works.
4. How do I use SPRYCEL?
Your doctor will decide the dose that is most appropriate for you.
Please follow your doctor's instructions about how and when to take SPRYCEL.
5. What should I know while using SPRYCEL?
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Things you should do
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Remind any doctor, dentist, nurse or pharmacist you visit that you are using SPRYCEL.
Have any tests recommended by your doctor done as soon as possible.
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Things you should not do
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Do not give SPRYCEL to anyone else, even if they have the same condition as you or
your child.
Do not stop taking SPRYCEL, or lower the dosage, without checking with your doctor.
Do not stop taking SPRYCEL tablets because you or your child are feeling better unless
advised to do so by your doctor.
Do not take SPRYCEL with grapefruit or grapefruit juice.
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Driving or using machines
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SPRYCEL has been known to cause dizziness or light-headedness in some people. Make
sure that you know how you or your child may react to SPRYCEL before you drive a car,
operate machinery, or do anything else that could be dangerous if you are dizzy.
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Looking after your medicine
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Store it in a cool dry place away from moisture, heat or sunlight.
Keep the pack in a cool dry place where the temperature stays below 30°C.
Keep this medicine out of the sight and reach of children.
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6. Are there any side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets
them. Your doctor will discuss these with you and will explain the risks and benefits
of your treatment. Sometimes they may be serious and you may require medical attention.
Active ingredient:
dasatinib (duh-sat-in-ib)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SPRYCEL. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using SPRYCEL.
Where to find information in this leaflet:
1. Why am I using SPRYCEL?
SPRYCEL contains the active ingredient dasatinib. SPRYCEL acts by inhibiting the activity of proteins within the leukaemia cells of
patients with CML or Ph+ ALL. These proteins are responsible for the uncontrolled
growth of the leukaemia cells. By inhibiting these proteins, SPRYCEL kills the leukaemia
cells in the bone marrow and allows normal red cell, white cell and platelet production
to resume.
SPRYCEL is used to treat adults and children ages 12 months and older with chronic
myeloid leukaemia (CML). It is also used to treat adults and children ages 12 months
and older who have a particular form of acute lymphoblastic leukaemia (ALL) called
Philadelphia chromosome positive or Ph+ ALL.
Leukaemia is a cancer of immature white blood cells, which grow in the bone marrow.
Under normal circumstances, as these white blood cells mature, they enter the blood
stream where they fight infection and maintain the body's immune system. In leukaemia,
these immature white blood cells multiply in an uncontrolled manner, occupying the
bone marrow space and spilling out into the bloodstream. As a consequence, the production
of normal red blood cells (oxygen carrying cells), white blood cells (cells which
fight infection), and platelets (cells which help blood to clot) is compromised. Therefore
patients with leukaemia are at risk of developing serious anaemia, infections and
bleeding.
It is intended that SPRYCEL be used in adults with:
Newly diagnosed Ph+ CML in the chronic phase who have not received any prior therapies,
OR
Ph+ CML across all phases who are no longer benefiting from other therapies for these
diseases (resistance) or in patients who experience severe side effects to other therapies
(intolerance), OR
Newly diagnosed Ph+ ALL who have not received any prior therapies, OR
Ph+ ALL who are no longer benefiting from other therapies for these diseases (resistance)
or in patients who experience severe side effects to other therapies (intolerance).
It is intended that SPRYCEL be used in children with:
Newly diagnosed Ph+ CML in the chronic phase who have not received any prior therapies,
OR
Ph+ CML in the chronic phase who are no longer benefiting from other therapies for
these diseases (resistance) or in patients who experience severe side effects to other
therapies (intolerance), OR
Newly diagnosed Ph+ ALL who have not received any prior therapies.
There is no experience with SPRYCEL treatment in children under 1 year of age.
Ask your doctor if you have any questions about why SPRYCEL was prescribed for you
or your child.
2. What should I know before I use SPRYCEL?
Warnings
Do not use SPRYCEL if:
You or your child are allergic to dasatinib, or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
If the expiry date printed on the pack has passed. If you or your child takes this
medicine after the expiry date has passed, it may not work as well.
The packaging is torn or shows signs of tampering.
Check with your doctor if you or your child:
have any other medical conditions, especially the following: problems with your immune
system, liver problem, heart problem, lactose intolerant, hepatitis B infection
If you have not told your doctor about any of the above, tell them before you or your
child take SPRYCEL.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take SPRYCEL if you are a pregnant woman or intend to become pregnant.
SPRYCEL can cause harm to the unborn baby if it is given to a pregnant woman.
Tell your doctor if you are a sexually active man.
Men who take SPRYCEL are advised to use a condom to avoid pregnancy in their partner.
Tell your doctor if you are breast-feeding or plan to breast-feed.
Women who are taking SPRYCEL should not breast-feed.
Where to get further information
Your doctor is the best person to answer any further questions you may have about
SPRYCEL.
Anything your doctor tells you about SPRYCEL should be followed even if it is different
from what is in this leaflet.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may be affected by SPRYCEL or they may affect how well SPRYCEL works.
Tell your doctor if you or your child are taking:
ketoconazole, itraconazole, ritonavir, atazanavir, erythromycin, clarithromycin and
grapefruit juice may all increase the level of SPRYCEL in your bloodstream.
dexamethasone, phenytoin, carbamazepine, rifampicin, and phenobarbitone may all decrease
the levels of SPRYCEL in your bloodstream.
SPRYCEL may alter the blood levels of cyclosporin.
Blood thinning medicines such as warfarin sodium, aspirin or non steroidal anti-inflammatory
drugs (NSAIDs) taken with SPRYCEL may increase the risk of unwanted bleeding.
Oral diabetes medicines from the glitazone family of drugs may interact with SPRYCEL.
You or your child should avoid taking cimetidine, famotidine, ranitidine or omeprazole
while taking SPRYCEL as they all reduce stomach acid, which is necessary for the absorption
of SPRYCEL.
Medicines that neutralise stomach acid (antacids), such as aluminium hydroxide, magnesium hydroxide or calcium carbonate may be taken up to 2 hours before or 2 hours after SPRYCEL.
Some medicines may be affected by SPRYCEL, or may affect how well it works. You or
your child may need different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you. Your doctor or pharmacist has more information
on medicines to be careful with or avoid while taking SPRYCEL.
Know the medicines you take.
Keep a list of you or your child's medicines to show your doctor or pharmacist.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SPRYCEL.
4. How do I use SPRYCEL?
How much to take
The usual starting dose for adults is 100 mg once daily (either as one 100 mg tablet
or two 50 mg tablets). The entire dose of 100 mg is to be taken at one time either
in the morning or the evening.
Some adult patients may require an alternative starting dose (140 mg daily taken as
two 70 mg tablets). The entire dose of 140 mg is to be taken at one time either in
the morning or the evening.
The starting dose for children is determined by body weight. The entire dose prescribed
by your doctor should be taken at one time either in the morning of the evening.
Your doctor will decide the dose that is most appropriate for you. Please follow your
doctor's instructions about how and when to take SPRYCEL.
When to take SPRYCEL
You or your child should take SPRYCEL consistently at the same time each day (either
in the morning or in the evening), with or without a meal, as instructed by your doctor.
How to take SPRYCEL
Swallow your SPRYCEL tablet(s) whole with a glass of water. Do not break, cut, chew
or crush the tablet.
Do not take SPRYCEL with grapefruit or grapefruit juice.
How long to take SPRYCEL
You or your child should not stop taking SPRYCEL, or reduce the dose without first
talking to your doctor. Depending on you or your child's response and any side effects
that may be experienced, your doctor may adjust the dose of SPRYCEL, upward or downward,
or may temporarily discontinue the medicine.
If you forget to use SPRYCEL
If you miss a dose of SPRYCEL, take the next scheduled dose at its regular time. Don't
make up for a missed dose by doubling up on tablets. Call your doctor or pharmacist
if you are not sure what to do.
If you use too much SPRYCEL
If you think that you have used too much SPRYCEL, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using SPRYCEL?
Things you should do
If you or your child are about to be started on any new medicine, tell your doctor
and pharmacist that you are taking SPRYCEL.
Have any tests recommended by your doctor done as soon as possible. Your doctor may order routine laboratory tests to evaluate your blood counts to see
how well SPRYCEL is working.
Call your doctor straight away if you or your child:
become pregnant while taking SPRYCEL
experience bleeding or easy bruising, no matter how mild
develop a fever while taking SPRYCEL
experience shortness of breath and fatigue while taking SPRYCEL
Remind any doctor, dentist or pharmacist you visit that you are using SPRYCEL.
Things you should not do
Do not give SPRYCEL to anyone else, even if they have the same condition as you or
your child.
Do not stop taking SPRYCEL, or lower the dosage, without checking with your doctor.
Do not stop taking SPRYCEL tablets because you or your child are feeling better unless
advised to do so by your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SPRYCEL
affects you.
SPRYCEL has been known to cause dizziness or light-headedness in some people. Make
sure that you know how you or your child react to SPRYCEL before you drive a car,
operate machinery, or do anything else that could be dangerous if you are dizzy.
Looking after your medicine
Keep SPRYCEL tablets in the pack until it is time to take them. If you or your child take the tablets out of the bottle they may not keep well.
Keep the pack in a cool dry place where the temperature stays below 30°C.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep this medicine out of the sight and reach of children.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
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Serious side effects
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What to do
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swelling, weight gain, shortness of breath or chest pain
swelling around your eyes
skin infection - folliculitis, herpes
shortness of breath and fatigue
dark coloured urine, yellowing of your skin and eyes, nausea, loss of appetite, light-coloured
bowel movements
changes in the way your heart beats, for example - if you notice it beating faster
bleeding - for example from: gastrointestinal tract; eye; nose; gums; serious bruising
or excessive menstrual bleeding
infections - urinary tract; eye infection; difficulty breathing; coughing
fever
painful rash with blisters
a reduction in red blood cells, which may result in fatigue or dizziness
a reduction in white blood cells, which are used to fight infection
a reduction in cells that help your blood to clot after injury
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Other side effects
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Common side effects
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What to do
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headache; dizziness; numbness or tingling in arms, legs, fingers or toes; altered
taste
diarrhoea, nausea, vomiting
shortness of breath, cough, accumulation of fluid in or around the lungs, pneumonia,
chest pain
infection, fever
abdominal pain, bloating, flatulence, constipation, indigestion
high blood pressure
mouth ulcers
skin rash, dermatitis (including eczema), dry skin, itching or peeling skin, flushing
hair loss
visual disturbances: blurry or diminished vision, dry eye
fatigue
swelling of the liver, abdomen, hands, lower legs, feet or face
back pain, bone pain, joint pain, pain in fingers or toes, muscle aches or spasm,
muscle weakness
weight decrease, appetite disturbance
gout
conjunctivitis
tinnitus (ringing in the ears)
accumulation of fluid, foamy urine, weight gain (also known as nephrotic syndrome)
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Speak to your doctor if you have any of these side effects and they worry you.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SPRYCEL contains
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Active ingredient
(main ingredient)
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dasatinib
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
hyprolose
croscarmellose sodium
magnesium stearate
Opadry White YS-1-18177-A
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Potential allergens
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lactose monohydrate
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Do not take this medicine if you are allergic to any of these ingredients.
What SPRYCEL looks like
SPRYCEL 20 mg tablet
White to off-white, biconvex, round tablet with "BMS" debossed on one side and "527"
on the other
SPRYCEL 50 mg tablet
White to off-white, biconvex, oval tablet with "BMS" debossed on one side and "528"
on the other
SPRYCEL 70 mg tablet
White to off-white, biconvex, round tablet with "BMS" debossed on one side and "524"
on the other
SPRYCEL 100 mg tablet
White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one
side and "852" on the other
Registration numbers
AUST R 125557 - 20 mg tablet - 60 tablets per bottle
AUST R 125559 - 50 mg tablet - 60 tablets per bottle
AUST R 125561 - 70 mg tablet - 60 tablets per bottle
AUST R 157352 - 100 mg tablet - 30 tablets per bottle
AUST R 125558 - 20 mg tablet - 60 tablets per blister pack (not marketed)
AUST R 125560 - 50 mg tablet - 60 tablets per blister pack (not marketed)
AUST R 125562 - 70 mg tablet - 60 tablets per blister pack (not marketed)
AUST R 157356 - 100 mg tablet - 30 tablets per blister pack (not marketed)
Who distributes SPRYCEL
Bristol-Myers Squibb Australia Pty Ltd
4 Nexus Court, Mulgrave,
Victoria 3170, Australia.
Toll free number: 1800 067 567
SPRYCEL® is a registered trademark of Bristol-Myers Squibb Company
This leaflet was prepared in October 2023.