Consumer medicine information

DASATINIB-TEVA®

DASATINIB-TEVA®

Active ingredient(s): Dasatinib (duh-sat-in-ib)


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?
2. What should I know before I use DASATINIB-TEVA?
3. What if I am taking other medicines?
4. How do I use DASATINIB-TEVA?
5. What should I know while using DASATINIB-TEVA?
6. Are there any side effects?
7. Product details

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 if you or your child experience bleeding or easy bruising, no matter how mild

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 or operate machinery.

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, do not 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

Less serious side effects What to do
  • 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)
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
  • 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
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.

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

Active ingredient
(main ingredient)
Dasatinib
Other ingredients
(inactive ingredients)
  • lactose monohydrate
  • microcrystalline cellulose
  • hyprolose
  • croscarmellose sodium
  • magnesium stearate
  • Opadry White YS-1-7027

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 March 2021.