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-TEVA?
DASATINIB-TEVA contains the active ingredient dasatinib. DASATINIB-TEVA is used to
treat adults and children ages 12 months and older with chronic myeloid leukaemia
(CML). For more information, see Section
1. Why am I using DASATINIB-TEVA? in the full CMI.
2. What should I know before I use DASATINIB-TEVA?
Do not use if you have ever had an allergic reaction to DASATINIB-TEVA 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. For more information, see Section
2. What should I know before I use DASATINIB-TEVA? in the full CMI.
3. What if I am taking other medicines?
4. How do I use DASATINIB-TEVA?
Follow all directions given to you by your doctor or pharmacist carefully.
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.
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 or the evening.
5. What should I know while using DASATINIB-TEVA?
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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-TEVA.
If you become pregnant while you are being treated with this medicine, tell your doctor
immediately.
Keep all your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do not stop using this medicine suddenly or start taking a lower dose without consulting
your doctor.
Do not give this medication to anyone else, even if they have the same condition as
you.
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Driving or using machines
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This medicine has been known to cause dizziness or light-headedness in some patients.
Make sure you know how DASATINIB-TEVA affects you before driving or operating machinery.
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Looking after your medicine
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Store DASATINIB-TEVA in a cool dry place, out of direct light, where the temperature
is below 25°C.
Keep DASATINIB-TEVA in the original packaging, in a safe place, away from children.
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6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you or your child do not feel
well while you are taking DASATINIB-TEVA, even if you do not think it is connected
with the medicine. This medicine helps most people with chronic myeloid leukaemia
(CML), however, like all medicines, DASATINIB-TEVA can have side effects, although
not everybody gets them. Sometimes they are serious, most of the time they are not.
You may need medical attention if you get some of these side effects.
Active ingredient(s):
Dasatinib (duh-sat-in-ib)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DASATINIB-TEVA. 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-TEVA.
Where to find information in this leaflet:
1. Why am I using DASATINIB-TEVA?
DASATINIB-TEVA contains the active ingredient dasatinib. Dasatinib is a tyrosine kinase inhibitor and 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, dasatinib kills the leukaemia cells in the bone marrow
and allows normal red cell, white cell, and platelet production to resume.
DASATINIB-TEVA 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 DASATINIB-TEVA be used in adults with:
newly diagnosed Ph+ CML in the chronic phase 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 DASATINIB-TEVA 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 dasatinib treatment in children under 1 year of age.
Ask your doctor if you have any questions about why DASATINIB-TEVA was prescribed
for you or your child.
2. What should I know before I use DASATINIB-TEVA?
Warnings
Do not use DASATINIB-TEVA 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.
Check with your doctor if you or your child:
have any other medical conditions or problems with your immune system, heart, or liver,
are lactose intolerant or have ever had a hepatitis B infection.
Take any medicines for any other condition.
Have an allergy to any other substances such as foods, preservatives, or dyes.
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 use DASATINIB-TEVA if you are pregnant or intend to become pregnant.
DASATINIB-TEVA can cause harm to the unborn baby if it is given to a pregnant woman.
Women who are taking DASATINIB-TEVA should not breast-feed.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you or your child 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 interfere with DASATINIB-TEVA and affect how it works.
Nizoral® (ketoconazole), Sporanox® (itraconazole), Norvir® (ritonavir), Reyataz® (atazanavir), E-Mycin® (erythromycin), Klacid® (clarithromycin) and grapefruit juice may all increase the level of DASATINIB-TEVA
in your bloodstream.
Maxidex® (dexamethasone), Dilantin® (phenytoin), Tegretol® (carbamazepine), Rifadin® (rifampicin), and Phenobarbitone tablets may all decrease the levels of DASATINIB-TEVA
in your bloodstream.
DASATINIB-TEVA may alter the blood levels of Sandimmun® (cyclosporin).
Blood thinning medicines such as Coumadin® (warfarin sodium), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) taken
with DASATINIB-TEVA may increase the risk of unwanted bleeding.
Oral diabetes medicines from the glitazone family of drugs may interact with DASATINIB-TEVA
You or your child should avoid taking Tagamet® (cimetidine), Pepcidine® (famotidine), Zantac® (ranitidine) or Probitor® (omeprazole) while taking DASATINIB-TEVA as they all reduce stomach acid, which is
necessary for the absorption of DASATINIB-TEVA.
Medicines that neutralise stomach acid, such as Mylanta® (aluminium hydroxide/magnesium hydroxide), Andrews Tums Antacid® (calcium carbonate) or Mylanta® (calcium carbonate and magnesium hydroxide) may be taken up to 2 hours before or
2 hours after DASATINIB-TEVA.
Some medicines may be affected by DASATINIB-TEVA 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 DASATINIB-TEVA.
Know the medicines you take.
Keep a list of you or your child's medicines with you 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 DASATINIB-TEVA.
4. How do I use DASATINIB-TEVA?
How much to take
You or your child 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 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 or 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 DASATINIB-TEVA.
Follow the instructions provided and use DASATINIB-TEVA until your doctor tells you
to stop.
When to take DASATINIB-TEVA
DASATINIB-TEVA should be taken at the same time each day, with or without a meal,
as instructed by your doctor.
How to take DASATINIB-TEVA
Swallow your DASATINIB-TEVA tablet(s) whole with a glass of water.
Do not break, cut, chew, or crush the tablet.
Do not take DASATINIB-TEVA with grapefruit, or grapefruit juice.
How long to take DASATINIB-TEVA
You or your child should not stop taking DASATINIB-TEVA or reduce the dose without
first talking to your doctor. Depending on you or your child's response and on any
side effects that you may experience, your doctor may adjust your dose of DASATINIB-TEVA,
upward or downward, or may temporarily discontinue your medicine.
If you forget to use DASATINIB-TEVA
DASATINIB-TEVA should be used regularly at the same time each day. If you miss your
dose at the usual time, take your next scheduled dose at its regular time.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
Call your doctor or pharmacist if you are not sure what to do.
If you think that you have used too much DASATINIB-TEVA, 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-TEVA?
Things you should do
Tell your doctor if you are a sexually active man. Men who take DASATINIB-TEVA are
advised to use a condom to avoid pregnancy in their partner.
You must tell your doctor immediately if you become pregnant while taking DASATINIB-TEVA
or your partner has been taking DASATINIB-TEVA.
Tell all of the doctors, dentists and pharmacists who are treating you that you or
your child are taking DASATINIB-TEVA.
Call your doctor straight away if you:
become pregnant while taking DASATINIB-TEVA or your partner has been taking DASATINIB-TEVA
or your child experience bleeding or easy bruising, no matter how mild
develop a fever while taking DASATINIB-TEVA
experience shortness of breath and fatigue while taking DASATINIB-TEVA
If you or your child are about to be started on any new medicine, tell your doctor
and pharmacist that you are taking DASATINIB-TEVA.
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-TEVA is working.
Things you should not do
Do not give DASATINIB-TEVA to anyone else, even if they have the same condition as
you.
Do not use DASATINIB-TEVA to treat any other complaints unless your doctor tells you
to.
Do not stop taking DASATINIB-TEVA, or lower the dosage, without checking with your
doctor.
Do not stop taking DASATINIB-TEVA because you 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 DASATINIB-TEVA
affects you.
DASATINIB-TEVA has been known to cause dizziness or light-headedness in some people.
Make sure you know how you react to DASATINIB-TEVA before you drive a car, operate
machinery or do anything else that could be dangerous if you are dizzy.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol is not expected to interact with DASATINIB-TEVA. If you drink alcohol, talk
to your doctor about the possible effects of taking alcohol with this medicine.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your tablets in the original pack until it is time to take them. If you take
your tablets out of the pack, they may not keep well.
Store DASATINIB-TEVA in a cool dry place below 25°C, away from moisture, heat, or
sunlight; for example, store it:
in the bathroom or near a sink, or
in the car or on windowsills.
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.
Less serious side effects
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Less serious 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 less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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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
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 or yellowing of your skin and eyes
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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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The use of DASATINIB-TEVA is also associated with a reduction in certain types of
blood cells in the body:
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
These are serious side effects. If you or your child have them, you may need urgent
medical attention.
Tell your doctor or pharmacist if you notice anything else that may be making you
or your child 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 or your child 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-TEVA 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-1-7027
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Do not take this medicine if you or your child are allergic to any of these ingredients.
What DASATINIB-TEVA looks like
DASATINIB-TEVA 20 mg tablet
White to off-white, round film-coated tablets with bevelled edges and debossed "20"
on one side of the tablet
DASATINIB-TEVA 50 mg tablet
White to off-white, oval film-coated tablets with bevelled edges and debossed "50"
on one side of the tablet
DASATINIB-TEVA 70 mg tablet
White to off-white, round film-coated tablets with bevelled edges and debossed "70"
on one side of the tablet
DASATINIB-TEVA 100 mg tablet
White to off-white, oval film-coated tablets with bevelled edges and debossed "100"
on one side of the tablet
Australian Registration Numbers
DASATINIB-TEVA 20 mg tablet – 60 tablets per bottle
AUST R 332653
DASATINIB-TEVA 50 mg tablet – 60 tablets per bottle
AUST R 332651
DASATINIB-TEVA 70 mg tablet – 60 tablets per bottle
AUST R 332652
DASATINIB-TEVA 100 mg tablet – 30 tablets per bottle
AUST R 332654
Who distributes DASATINIB-TEVA?
DASATINIB-TEVA is supplied in Australia by:
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
DASATINIB-TEVA is supplied in New Zealand by:
Teva Pharma (New Zealand) Limited
Auckland, New Zealand
This leaflet was prepared in January 2024.