Patient Medication Information: uses, side effects, how to take - Teva-Dasatinib
Serious Warnings and Precautions box
Take TEVA-DASATINIB only under the care of a doctor who knows how to use anti-cancer drugs.
Serious and common side effects with TEVA-DASATINIB include:
Myelosuppression (thrombocytopenia, neutropenia, anemia): TEVA-DASATINIB can affect your body’s ability to make blood cells. It can cause you to have low blood cell counts.
- Neutropenia is a low white blood cell count. It can occur with and without a fever and can cause you to get infections.
- Thrombocytopenia is low platelets in the blood. Platelets help with clotting.
- Anemia is a low red blood cell count.
Your doctor will do regular blood tests to monitor you for myelosuppression.
- Bleeding, which may result in death
- Fluid retention
- Congestive heart failure (CHF): This is when your heart doesn’t pump as well as it should. Signs and symptoms of CHF are shortness of breath, swelling and weight gain, which are usually accompanied by fluid retention and pulmonary edema. Pulmonary edema is when fluid builds up in the lung.
- Pulmonary Arterial Hypertension: This is a condition where the blood pressure in the arteries of the lung is high.
What TEVA-DASATINIB is used for:
TEVA-DASATINIB is used to treat adults with certain types of leukemia including:
- Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase that has been recently diagnosed;
- Ph+ CML that is no longer benefiting from other available therapies for CML, including imatinib mesylate;
- Ph+ acute lymphoblastic leukemia (ALL) that no longer responds to other therapies.
How TEVA-DASATINIB works?
Leukemia is a cancer that affects different types of white blood cells. In patients with leukemia, these white blood cells are abnormal. They don’t work properly and can multiply in an uncontrolled way.
TEVA-DASATINIB acts by stopping the activity of proteins in these abnormal white blood cells. This helps to slow the uncontrolled growth of the white blood cells.
The ingredients in TEVA-DASATINIB are?
Medicinal ingredient: dasatinib (as dasatinib monohydrate).
Non-medicinal ingredients: Croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.
TEVA-DASATINIB comes in the following dosage form (s):
Tablets, 20 mg, 50 mg, 70 mg, 80 mg and 100 mg.
Do not use TEVA-DASATINIB if:
- You are allergic to dasatinib or to any other ingredients in TEVA-DASATINIB. Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.
You are breast-feeding.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-DASATINIB. Talk about any health conditions or problems you may have, including if you:
- Have a liver problem.
- Have a heart problem, such as an irregular heartbeat or a hereditary disorder of the heart’s electrical activity, called long QT syndrome.
- Have or have previously had a hepatitis B infection. This is an infection of the liver. TEVA-DASATINIB could cause the hepatitis B virus to become active again, which can lead to death in some cases. Your doctor will check for signs of this infection before starting treatment with TEVA-DASATINIB. If the hepatitis B virus is found, you will be monitored closely during and for several months after treatment with TEVA-DASATINIB.
Are lactose intolerant or have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp Lactase deficiency
- Glucose-galactose malabsorption
This is because lactose is a non-medicinal ingredient in TEVA-DASATINIB.
- Are taking medicines to thin the blood or prevent clots. TEVA-DASATINIB may cause bleeding.
- Have muscle aches/pains or weakness, or dark-colored urine.
Other warnings you should know about:
Female patients:
- If you are pregnant or planning to become pregnant there are specific risks you must discuss with your healthcare professional.
- Do not become pregnant while taking TEVA-DASATINIB. It may harm your unborn baby or make you lose the pregnancy.
- Use highly effective methods of birth control while taking TEVA-DASATINIB. Your healthcare professional can tell you about the types of birth control available to you.
- If you do become pregnant while you are using TEVA-DASATINIB, tell your healthcare professional right away.
- TEVA-DASATINIB may affect your ability to have a child in the future. Talk to your healthcare professional if you have questions about this.
Male patients:
- Use highly effective methods of birth control each time you have sex with a woman during your treatment with TEVA-DASATINIB.
Blood tests:
During your treatment with TEVA-DASATINIB you will need to have blood tests done. These will be done about every 1 to 2 weeks for the first few months of your treatment. You will then need to have these tests repeated once every 1 to 3 months. These tests will tell your healthcare professional how TEVA-DASATINIB is affecting your blood. They will also show how well your liver and kidneys are working.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TEVA-DASATINIB:
- Medicines used to treat irregular heart beat such as: disopyramide, procainamide, amiodarone, sotalol, ibutilide and flecainide.
- Medicines used to stabilize your mood like benzodiazepine, chlorpromazine, haloperidol and pimozide.
- Medicines used to treat chronic or severe pain like methadone.
- Medicines used to treat malaria like chloroquine.
- A medicine that stimulates stomach and bowel movement called domperidone.
- Medicines used to treat fungal infections, like ketoconazole and itraconazole.
- Medicines used to treat bacterial infections like erythromycin and clarithromycin, quinolone, moxifloxacin.
- A medicine used to treat HIV the virus that causes AIDS like ritonavir, lopinavir and atazanavir.
- A medicine used to treat tuberculosis called rifampicin.
- Medicines used to treat epilepsy like carbamazepine, phenytoin and phenobarbital.
- Medicines used to treat high cholesterol like simvastatin.
- A medicine used to prevent organ rejection or treat autoimmune conditions called cyclosporine.
- Medicines used to treat inflammation like dexamethasone.
- An herbal remedy used to treat depression called St. John’s Wort.
- Medicines used to treat severe headaches or migraines like ergotamine and dihydroergotamine.
Do not eat or drink any products or juices that contain grapefruit or grapefruit juice. These can affect how TEVA-DASATINIB works.
Avoid taking medicines that neutralise stomach acids. Examples are antacids such as cimetidine, famotidine, ranitidine and omeprazole. If you must use these medicines, take them at least 2 hours before or 2 hours after taking TEVA-DASATINIB.
Tell your doctor if you are taking medicines to thin the blood or prevent clots like warfarin sodium or aspirin.
How to take TEVA-DASATINIB:
- Exactly as directed by your healthcare professional.
- Once per day, either in the morning or in the evening.
With or without food, at about the same time each day.
- Swallow whole. Do not crush or cut tablets.
Usual Dose:
Note: TEVA-DASATINIB manufactured by Teva Canada Limited. is NOT available in the 140 mg strength.
Your dose of TEVA-DASATINIB will depend on the type of leukemia you have.
Usual starting dose for chronic phase CML: 100 mg once a day.
- Usual starting dose for accelerated or blast crisis CML or Ph+ ALL: 140 mg once a day.
Your healthcare professional may interrupt or change your dose of TEVA-DASATINIB if:
- You are taking certain medications,
- You do not tolerate the treatment, or
- Your disease gets worse.
Overdose:
If you take too much TEVA-DASATINIB, you may experience side effects including low platelet counts.
If you think you, or a person you are caring for, have taken too much TEVA-DASATINIB, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s tollfree number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss a dose of TEVA-DASATINIB, wait until it is time for your next dose. Do not take two doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do.
What are possible side effects from using TEVA-DASATINIB?
These are not all the possible side effects you may have when taking TEVA-DASATINIB. If you experience any side effects not listed here, tell your healthcare professional.
- Diarrhea
- Nausea
- Vomiting
- Stomach pain
- Fever
- Headache
- Fatigue
- Skin rash
- Shortness of breath
- Cough
- Upper respiratory tract infection
- Infection
- Pain
- Bone and extremity pain
- Muscle and joint aches
TEVA-DASATINIB can cause abnormal blood test results. Your doctor will decide when to test your blood and will interpret the results.
The following have been reported in patients using dasatinib: inflammation of the lungs, blood clots, irregular heart rhythm, and deaths from gastrointestinal bleeding. These may or may not have been related to dasatinib.
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Myelosuppression (low blood cell counts): such as anemia (low red blood cell counts), neutropenia (low white blood cell counts), or thrombocytopenia (low platelet counts) | √ | ||
| Bleeding (loss of blood or bruising without having an injury no matter how mild): bleeding, bruising, blood in vomit, stools or urine, or black stools, bleeding from the nose or gums, excessive period bleeding | √ | ||
| Fluid retention (build-up of water in your body, which can be in the lining of your lungs or around your heart): swelling anywhere on or in your body, weight gain; shortness of breath, especially after low levels of physical exertion; chest pain when taking a deep breath | √ | ||
| Heart problems (irregular heart rate, heart attack): heartbeat that is abnormally slow, fast or forceful, shortness of breath, dizziness or feeling faint, chest pain accompanied with fatigue, nausea or cold sweats | √ | ||
| Infections (bacterial or viral illness): fever, severe chills, discharge (fluid) with mucus or pus | √ | ||
Growth retardation in children: when a child is not growing at a normal rate for their age | √ | ||
| UNCOMMON | |||
| Liver damage (inflammation of the liver, increased liver enzyme levels on blood tests): yellow skin and/or eyes, nausea, loss of appetite, dark-coloured urine | √ | ||
| Rhabdomyolysis (breakdown of damaged muscle): muscle aches and pain, weakness, dark urine | √ | ||
| RARE | |||
| Pulmonary arterial hypertension | |||
| (increased blood pressure in the arteries supplying the lungs): shortness of breath, fatigue | √ | ||
| VERY RARE | |||
| Stevens-Johnson syndrome (severe skin reaction): redness, blistering and/or peeling of the skin or mucous membranes (skin of lips, eyes, mouth, nasal passages, genitals) with fever, sore mouth or throat, can lead to death | √ | ||
| Hepatitis B virus reactivation (an active viral infection of the liver): Weight loss, fever, abdominal pain, nausea and vomiting followed by jaundice (yellowing of the skin or whites of eyes) | √ | ||
| Erythema multiforme (severe skin reaction): raised red or purple skin patches with itching or burning, sores with puss | √ | ||
| Thrombotic microangiopathy (damage to blood vessels): Bruising, bleeding, weakness, fever, fatigue and confusion | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature between 15°C to 30°C.
Keep out of reach and sight of children.
Do not use TEVA-DASATINIB after the expiry date written on the label, blister or carton after EXP.
If you want more information about TEVA-DASATINIB:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com .
Date of Revision: JAN 22, 2026