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 SUN?
DASATINIB SUN contains the active ingredient dasatinib. DASATINIB SUN 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.
For more information, see Section 1. Why am I using DASATINIB SUN? in the full CMI.
2. What should I know before I use DASATINIB SUN?
Do not use if you have ever had an allergic reaction to DASATINIB SUN 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 SUN? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with DASATINIB SUN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use DASATINIB SUN?
- The usual starting dose for adults is 100 mg once daily (either as one 100 mg tablet or two 50 mg tablets).
- The doctor will prescribe the starting dose for children is determined by body weight.
More instructions can be found in Section 4. How do I use DASATINIB SUN? in the full CMI.
5. What should I know while using DASATINIB SUN?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using this medicine? in the full CMI.
6. Are there any side effects?
Some side effects are dizziness, shortness of breath, diarrhea, fever, and change to heart rate.
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.
DASATINIB SUN
Active ingredient(s): (dasatinib film-coated tablets)
Consumer Medicine Information (CMI)
This leaflet provides important information about using DASATINIB SUN. 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 SUN.
Where to find information in this leaflet:
1. Why am I using DASATINIB SUN?
2. What should I know before I use DASATINIB SUN?
3. What if I am taking other medicines?
4. How do I use DASATINIB SUN?
5. What should I know while using DASATINIB SUN?
6. Are there any side effects?
7. Product details
1. Why am I using DASATINIB SUN?
DASATINIB SUN contains the active ingredient dasatinib.
DASATINIB SUN 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.
It is intended that DASATINIB SUN 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 DASATINIB SUN 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 SUN treatment in children under 1 year of age. Ask your doctor if you have any questions about why DASATINIB SUN was prescribed for you or your child. This medicine is available only with a doctor’s prescription.
2. What should I know before I use DASATINIB SUN?
Warnings
Do not use DASATINIB SUN if:
- you or your child have severe allergic reactions 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:
- have any other medical conditions:
– problems with your immune system
– liver problem
– heart problem
– lactose intolerant
– hepatitis B infection - are breast feeding or plan to breast-feed. Women who are taking DASATINIB SUN should not breast-feed.
- are a sexually active man. Men who take DASATINIB SUN are advised to use a condom to avoid pregnancy in their partner.
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
Check with your doctor if you are pregnant or intend to become pregnant.
Women who are taking DASATINIB SUN should not breast-feed.
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.
Medicines that may increase the effect of DASATINIB SUN include:
- Nizoral® (ketoconazole), Sporanox® (itraconazole), Norvir® (ritonavir), Reyataz® (atazanavir), E-Mycin® (erythromycin), Klacid® (clarithromycin) and grapefruit juice may all increase the level of DASATINIB SUN in your bloodstream.
Medicines that may reduce the effect of DASATINIB SUN include:
- Maxidex® (dexamethasone), Dilantin® (phenytoin), Tegretol® (carbamazepine), Rifadin® (rifampicin), and Phenobarbitone tablets may all decrease the levels of DASATINIB SUN in your bloodstream.
Tell your doctor or pharmacist if you take other medicines for any other condition:
- DASATINIB SUN 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 SUN may increase the risk of unwanted bleeding.
- Oral diabetes medicines from the glitazone family of drugs may interact with DASATINIB SUN.
You or your child should avoid taking Tagamet® (cimetidine), Pepcidine® (famotidine), Zantac® (ranitidine) or Probitor® (omeprazole) while taking DASATINIB SUN as they all reduce stomach acid, which is necessary for the absorption of DASATINIB SUN.
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 SUN.
Some medicines may be affected by DASATINIB SUN 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 SUN.
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 this medicine.
4. How do I use DASATINIB SUN?
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 DASATINIB SUN.
Follow the instructions provided and use this medicine until your doctor tells you to stop.
When to take this medicine
You or your child should take these tablets consistently either in the morning or in the evening, with or without a meal, as instructed by your doctor.
How to take his medicine
Swallow your DASATINIB SUN tablet(s) whole with a glass of water. Do not break, cut, chew or crush the tablet. DASATINIB SUN. Do not take DASATINIB SUN with grapefruit or grapefruit juice.
If you forget to use this medicine
If you miss a dose of DASATINIB SUN, take the next scheduled dose at its regular time.
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 use too much of this medicine
If you think that you have used too much of this medicine 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 SUN?
Things you should do
- You must tell your doctor immediately if you or your child become pregnant while taking DASATINIB SUN.
- Tell all of the doctors, dentists and pharmacists who are treating you or your child that you are taking DASATINIB SUN.
- If you or your child are about to be started on any new medicine, tell your doctor and pharmacist that you are taking DASATINIB SUN.
Your doctor may order routine laboratory tests to evaluate your blood counts to see how well DASATINIB SUN is working.
Call your doctor straight away if you:
- if you or your child develop a fever while taking DASATINIB SUN.
- if you or your child experience shortness of breath and fatigue while taking DASATINIB SUN
- if you or your child experience bleeding or easy bruising, no matter how mild. Have any tests recommended by your doctor done as soon as possible.
Things you should not do
- Do not give DASATINIB SUN to anyone else, even if they have the same condition as you or your child.
- Do not use DASATINIB SUN to treat any other complaints unless your doctor tells you to.
- Do not stop taking DASATINIB SUN, or lower the dosage, without checking with your doctor.
- Do not stop taking DASATINIB SUN 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 this medicine affects you.
DASATINIB SUN has been known to cause dizziness or light headedness in some people. Make sure that you know how you or your child react to DASATINIB SUN before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy.
Looking after your medicine
- DASATINIB SUN tablets should be stored below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
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.
When to discard your medicine
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
Less side effects | What to do |
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Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
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Tell your doctor immediately, or go to accident and emergency at your nearest hospital. |
The use of DASATINIB SUN is also associated with a reduction in certain types of blood cells in the body:
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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. |
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 SUN contains
Active ingredient (main ingredient) |
dasatinib |
Other ingredients (inactive ingredients) |
lactose monohydrate, calcium hydrogen phosphate, colloidal anhydrous silica, hyprolose, croscarmellose sodium, magnesium stearate and PI no. 141436 OPADRY Complete Film Coating System 03K580013 White. |
Potential allergens | lactose monohydrate |
Do not take this medicine if you are allergic to any of these ingredients.
What this medicine looks like
DASATINIB SUN 20 mg tablet
White to off-white, biconvex, round, film-coated tablet debossed with “851” on one side and plain on other side. AUST R 375034 (bottle) and 375036 (blister) 20 mg tablet – Al/Al blister packs or HDPE CRC bottles
DASATINIB SUN 50 mg tablet
White to off-white, biconvex, oval, film-coated tablet debossed with “852” on one side and plain on other side. AUST R 375035 (bottle) and 375039 (blister) 50 mg tablet – Al/Al blister packs or HDPE CRC bottles
DASATINIB SUN 70 mg tablet
White to off-white, biconvex, round, film-coated tablet debossed with “853” on one side and plain on other side. AUST 375022 (bottle) and 375038 (blister) 70 mg tablet – Al/Al blister packs or HDPE CRC bottles
DASATINIB SUN 100 mg tablet
White to off-white, biconvex, oval, film-coated tablet debossed with “855” on one side and plain on other side. AUST R 375044 (bottle) and 375043 (blister) 100 mg tablet – Al/Al blister packs or HDPE CRC bottles
Who distributes this medicine
Sun Pharma ANZ Pty Ltd.
Macquarie Park, NSW 2113
customerservice.aus@sunpharma.com
Tel: 1800 726 229
This leaflet was prepared in 20 July 2022.
Published by MIMS April 2023