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 DASATINIB VIATRIS?
DASATINIB VIATRIS contains the active ingredient dasatinib. DASATINIB VIATRIS is used
to treat adults aged 18 years and older with:
Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia
in the chronic phase.
Chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia
with resistance or intolerance to prior therapy including imatinib.
Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or
intolerance to prior therapy.
2. What should I know before I use DASATINIB VIATRIS?
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?
4. How do I use DASATINIB VIATRIS?
Your doctor will decide the dose that is most appropriate for you.
Please follow your doctor's instructions about how and when to take DASATINIB VIATRIS.
5. What should I know while using DASATINIB VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using DASATINIB VIATRIS.
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 DASATINIB VIATRIS to anyone else, even if they have the same condition
as you.
Do not stop taking DASATINIB VIATRIS, or lower the dosage, without checking with your
doctor.
Do not stop taking DASATINIB VIATRIS tablets because you are feeling better unless
advised to do so by your doctor.
Do not take DASATINIB VIATRIS with grapefruit or grapefruit juice.
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Driving or using machines
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DASATINIB VIATRIS has been known to cause dizziness or light-headedness in some people.
Make sure that you know how you may react to DASATINIB VIATRIS 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 25°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.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
dasatinib (duh-sat-in-ib)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DASATINIB VIATRIS. 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 DASATINIB VIATRIS.
Where to find information in this leaflet:
1. Why am I using DASATINIB VIATRIS?
DASATINIB VIATRIS contains the active ingredient dasatinib. DASATINIB VIATRIS works 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 dasatinib kills the leukaemia
cells in the bone marrow and allows normal red cell, white cell and platelet production
to resume.
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.
This medicine is available only with a doctor's prescription.
DASATINIB VIATRIS is used to treat adults aged 18 years or over with:
Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in
the chronic phase.
Chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia
with resistance or intolerance to prior therapy including imatinib.
Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or
intolerance to prior therapy.
It belongs to a group of medicines called protein-tyrosinekinase inhibitors.
2. What should I know before I use DASATINIB VIATRIS?
Warnings
Do not use DASATINIB VIATRIS if:
you 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.
The expiry date printed on the pack has passed
The packaging is torn or shows signs of tampering.
Do not give this medicine to a child under the age of 18 years.
Check with your doctor if you:
have or have had any of the following medical conditions:
problems with your immune system
liver problem
heart problem
lactose intolerant
hepatitis B infection.
are pregnant or plan to become pregnant or are breastfeeding. Women who are taking
dasatinib should not breast-feed. (See section Pregnancy and breastfeeding)
are a sexually active man. Men who take dasatinib are advised to use a condom to avoid
pregnancy in their partner.
have allergies to any other medicines, foods, preservatives or dyes
have recently been vaccinated or plan to get a vaccination
are planning to have surgery or an anaesthetic
are currently receiving or are planning to receive dental treatment.
If you have not told your doctor about any of the above, tell them before you start
taking this medicine.
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 this medicine if you are pregnant or plan to become pregnant.
DASATINIB VIATRIS 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 DASATINIB VIATRIS are advised to use a condom to avoid pregnancy in their
partner.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Women who are taking DASATINIB VIATRIS should not breast-feed.
Where to get further information
Your doctor is the best person to answer any further questions you may have about
DASATINIB VIATRIS. Anything your doctor tells you about DASATINIB VIATRIS 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 DASATINIB VIATRIS or they may affect how well DASATINIB
VIATRIS works.
Tell your doctor if you are taking:
Medicines that may increase dasatinib level in your bloodstream, such as ketoconazole,
itraconazole, erythromycin, clarithromycin, ritonavir, atazanavir, lopinavir, grapefruit
juice.
Medicines that may decrease dasatinib level in your bloodstream, such as dexamethasone,
phenytoin, carbamazepine, rifampicin, phenobarbital and St John’s wort.
Dasatinib may alter the blood levels of ciclosporin.
Medicines that reduce stomach acid, such as antacids and histamine-2 antagonists/proton
pump inhibitors (famotidine and omeprazole).
Medicines that may have their plasma concentration altered by dasatinib, such as simvastatin,
astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids.
Blood thinning medicines, such as warfarin, aspirin and non-steroidal anti-inflammatory
drugs (NSAIDs) taken with dasatinib may increase the risk of unwanted bleeding.
Oral diabetes medicines from the glitazone family of medicines may interact with dasatinib.
Medicines that neutralise stomach acid, such as aluminium hydroxide, magnesium hydroxide,
calcium carbonate and calcium carbonate/hydroxide. These medicines may be taken up to 2 hours before or 2 hours after dasatinib.
Some medicines may interfere with DASATINIB VIATRIS and affect how it works. You 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 DASATINIB VIATRIS.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DASATINIB VIATRIS.
4. How do I use DASATINIB VIATRIS?
How much to take / use
Your doctor will tell you how much of this medicine you should take. This will depend
on your condition and whether you are taking any other medicines.
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
You should take your tablets consistently either in the morning or in the evening.
The usual starting dose 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 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.
Do not stop taking your medicine or change your dosage without first talking with
your doctor. This medicine helps to control your condition but does not cure it. It
is important to keep taking your medicine even if you feel well.
Depending on your response and on any side effects that you may experience, your doctor
may adjust your dose of DASATINIB VIATRIS, upward or downward, or may temporarily
discontinue your medicine.
When to take DASATINIB VIATRIS
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take this medicine before or after food.
How to take DASATINIB VIATRIS
Swallow the tablets whole with a full glass of water.
Do not break, cut, chew or crush the tablet.
Do not take DASATINIB VIATRIS with grapefruit or grapefruit juice.
If you forget to take DASATINIB VIATRIS
If it is almost time for 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 your medicine
as you would normally.
Do not take a double dose to make up for the dose 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 have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much DASATINIB VIATRIS
If you think that you have used too much DASATINIB VIATRIS, 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 DASATINIB VIATRIS?
Things you should do
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
DASATINIB VIATRIS.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking DASATINIB VIATRIS.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
DASATINIB VIATRIS.
If you are about to have any blood tests, tell your doctor that you are taking DASATINIB
VIATRIS.
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 DASATINIB
VIATRIS is working.
Call your doctor straight away if you:
become pregnant or plan to breastfeed while taking DASATINIB VIATRIS
experience bleeding or easy bruising, no matter how mild
develop a fever while taking DASATINIB VIATRIS
experience shortness of breath and fatigue while taking DASATINIB VIATRIS
Remind any doctor, dentist or pharmacist you visit that you are using DASATINIB VIATRIS.
Things you should not do
Do not give DASATINIB VIATRIS to anyone else, even if they have the same condition
as you.
Do not stop taking DASATINIB VIATRIS tablets or lower the dosage, because you are
feeling better unless advised to do so by your doctor.
Do not take DASATINIB VIATRIS to treat any other complaints unless your doctor tells
you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DASATINIB
VIATRIS affects you.
DASATINIB VIATRIS has been known to cause dizziness or lightheadedness in some people.
Make sure that you know how you react to DASATINIB VIATRIS before you drive a car,
operate machinery, or do anything else that could be dangerous if you are dizzy.
Looking after your medicine
Keep DASATINIB VIATRIS tablets in the pack until it is time to take them. If you 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 25°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 it where young children cannot reach it.
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.
Other side effects
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 DASATINIB VIATRIS 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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microcrystalline cellulose
ethylcellulose
lactose monohydrate
croscarmellose sodium
magnesium stearate
colloidal silicon dioxide
hypromellose
hyprolose
triethyl citrate
titanium dioxide
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Potential allergens
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lactose monohydrate
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This medicine contains sugars as lactose.
This medicine does not contain gluten.
Do not take this medicine if you are allergic to any of these ingredients.
What DASATINIB VIATRIS looks like
Dasatinib 20 mg tablet
(blister: AUST R 290135, bottle: AUST R 290130)
White to off-white, round, biconvex coated tablet. Engraved "APO" on one side, over
"DA" over "20" on the other side.
Dasatinib 50 mg tablet
(blister: AUST R 290142, bottle: AUST R 290133)
White to off-white, oval, bevelled-edged, biconvex coated tablet. Engraved "APO" on
one side, "DAS50" on the other side.
Dasatinib 70 mg tablet
(blister: AUST R 290138, bottle: AUST R 290141)
White to off-white, round, biconvex coated tablet. Engraved "APO" on one side, "DA"
over "70" on the other side.
Dasatinib 100 mg tablet
(blister: AUST R 290139, bottle: AUST R 290132)
White to off-white, oval, bevelled-edged, biconvex coated tablet. Engraved "APO" on
one side, "DAS100" on the other side.
Who distributes DASATINIB VIATRIS
Sponsor
Helix Pharmaceuticals Pty Ltd
C/-EGA Corporate Advisers Pty Ltd
Level 12, 468 St Kilda Rd
Melbourne VIC 3004
Distributor
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in March 2024.