Dasatinib Teva Film-Coated Tablets

DASATINIB TEVA contains the active substance dasatinib. DASATINIB TEVA (dasatinib) is used to treat adults who have chronic myeloid leukaemia (CML) or have Philadelphia chromosome positive or Ph+ acute lymphoblastic leukaemia (ALL).

Do not take DASATINIB TEVA:

• if you are hypersensitive (allergic) to dasatinib or any of the other ingredients of DASATINIB TEVA (listed in section 6)
• using H 2 blockers or proton pump inhibitors with DASATINIB TEVA is not recommended.

Warnings and precautions:

Take special care with DASATINIB TEVA:

• if you have a liver problem
• if you have problems with your immune system
• if you are taking medicines to thin the blood or prevent clots (see Other medicines and DASATINIB TEVA)
• if you have heart problems, including a condition called congenital long QT syndrome
• if you have low potassium or low magnesium levels in your blood
• if you start having difficulty breathing, chest pain, or a cough when taking DASATINIB TEVA: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years or older), or due to changes in the blood vessels supplying the lungs
• if you experience bruising, bleeding, fever, fatigue and confusion when taking DASATINIB TEVA, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA)
• if you have ever had or might now have hepatitis B infection. This is because DASATINIB TEVA could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started
• if you have a history of skin problems
• if you have a history of stroke.

Your doctor will regularly monitor your condition to check whether DASATINIB TEVA is having the desired effect. You will also have blood tests regularly while you are taking DASATINIB TEVA.

Children and adolescents:

DASATINIB TEVA has not been studied in children.

Other medicines and DASATINIB TEVA:

Always tell your healthcare provider if you are taking any other medicines. (This includes all complementary or traditional medicines). DASATINIB TEVA is eliminated from your body through the liver. The use of certain other medicines may alter the levels of DASATINIB TEVA in your bloodstream. Likewise, levels of other medicines in your bloodstream can be affected by DASATINIB TEVA. Such changes can increase the side effects, or reduce the activity of the medicines you are taking, including DASATINIB TEVA.

Do not share medicines prescribed for you with any other person. Always take DASATINIB TEVA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

• The recommended starting dose for DASATINIB TEVA in patients with chronic phase CML is 100 mg once daily, with or without a meal. The recommended starting dose for DASATINIB TEVA in patients with accelerated, myeloid or lymphoid blast phase CML or Ph+ ALL is 70 mg twice daily, with or without a meal. Try to take DASATINIB TEVA at the same time each day.
• Swallow DASATINIB TEVA tablets whole. Do not break, cut, chew or crush the tablets.
• Depending on your response to treatment and any side effects that you may experience, your doctor may adjust your dose of DASATINIB TEVA upward or downward or may temporarily discontinue DASATINIB TEVA. Your doctor will tell you how long your treatment with DASATINIB TEVA will last. Do not stop treatment early. If you have the impression that the effect of DASATINIB TEVA is too strong or too weak, tell your doctor or pharmacist.

If you take more DASATINIB TEVA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take DASATINIB TEVA: If you miss a dose of DASATINIB TEVA, take your next scheduled dose at its regular time. Do not take a double dose to make up for forgotten individual doses. Call your doctor or pharmacist if you are not sure what to do.

DASATINIB TEVA can have side effects. Not all side effects reported for DASATINIB TEVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DASATINIB TEVA, please consult your healthcare provider for advice. The following information describes the most important side effects of DASATINIB TEVA. It is not a comprehensive list of all side effects recorded in clinical trials with DASATINIB TEVA. You should report any unusual symptoms to your doctor.

If any of the following happens, stop taking DASATINIB TEVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to DASATINIB TEVA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• if you have chest pain, difficulty breathing, coughing and fainting
• if you experience unexpected bleeding or bruising without having an injury
• if you find blood in your vomit, stools or urine, or have black stools
• if you get signs of infections such as fever, severe chills
• if you get fever, sore mouth or throat, blistering or peeling of your skin and/or mucous membranes.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• infections (including bacterial, viral and fungal), pneumonia, herpes viral infection, upper respiratory infection, serious infection of the blood or tissues (including fatal outcome)
• low blood platelet count, low white blood cell count (neutropenia), anaemia, fluid around the lungs, fluid around the heart, fluid in the lungs, febrile neutropenia
• loss of appetite, an excess of uric acid in the blood
• depression, sleeplessness
• headache, bad taste, sleepiness, weakness, numbness and pain from nerve damage, usually in the hands and feet
• visual disorder (including blurred vision and disturbed vision), dry eye
• persistent noise in ears
• irregular heartbeat, congestive heart failure, heart dysfunction, a sensation that the heart is racing, pounding, fluttering or skipping a beat, often bothersome, but hardly ever a sign of heart disease
• bleeding, high blood pressure, flushing
• shortness of breath, cough, increased blood pressure in the lungs, inflammation of lung tissue, a build-up of fluid between the tissues that line the lungs and the chest
• diarrhoea, feeling or being sick (nausea, vomiting), bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, gastritis
• skin rash, skin tingling, itching, dry skin, acne, inflammation of the skin, hair loss, excessive perspiration
• pain in the muscles, abdominal (tummy) pain, pain in joints, muscular weakness, stiffness in muscles and joints, muscle spasm
• tiredness, fever, facial swelling, pain, chest pain, chills, swelling of the hands and feet, lack of energy
• weight increase, weight decrease
• blood or bleeding under the skin due to trauma of any kind; typically black and blue at first, with colour changes as healing progresses.

Less frequent side effects:

• swelling of the lymph nodes, low levels of lymphocytes (a type of white blood cell) in the blood, body's bone marrow fails to work properly
• abnormally high thyroid function, a condition in which the thyroid gland doesn't produce enough thyroid hormone, inflammation of the thyroid gland
• abnormal blood test results and possibly impaired kidney function caused by the waste products of the dying tumour (tumour lysis syndrome), dehydration, high cholesterol levels in your blood, high blood sugar levels
• anxiety, confusion, mood swings, lower sexual drive
• fainting, tremor, loss of memory, stroke, temporary episode of neurologic dysfunction caused by loss of blood flow, facial nerve paralysis, dementia
• ataxia (a condition associated with lack of muscular coordination), seizures, inflammation of the optic nerve that may cause a complete or partial loss of vision
• sensitivity to light, visual impairment, increased eye tearing, inflammation of the eye
• loss of hearing, spinning
• heart attack (including fatal outcome), inflammation of the lining (fibrous sack) surrounding the heart, irregular heart rhythm, chest pain due to lack of blood supply to the heart (angina), low blood pressure, narrowing of airway that may cause breathing difficulties, enlargement of the right ventricle in the heart
• inflammation of the heart muscle, collection of conditions resulting from blockage of blood supply to the heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from the heart), coronary (heart) artery disease
• irregularity of the electrical activity of the heart, enlarged heart
• low blood pressure, blood clots, blood clot to form and block one or more veins, usually in your legs, feel numb and cold in response to cold temperatures or stress
• increased blood pressure in the arteries (blood vessels) of the lungs, inflammation of the tissue covering the heart and lungs, blood clots in the lungs, asthma, bronchoconstriction, condition in which fluid collects in the air sacs of the lungs, depriving organs of oxygen
• inflammation of the pancreas, peptic ulcer, inflammation of the food pipe, swollen tummy (abdomen), tear in the skin of the anal canal, difficulty in swallowing, gastro-oesophageal reflux (heartburn), loss of vital nutrients such as protein from your digestive tract, bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus)
• inflammation of the liver, blockage of bile ducts, inflammation of the gall bladder (causing yellowing of the skin and eyes)
• allergic reaction including tender, red lumps on the skin (erythema nodosum), inflammation of the eye which causes redness or pain, a skin disease characterised by tender, red, well-defined blotches with the sudden onset of fever and raised white blood cell count (neutrophilic dermatosis), disturbance in skin colour, inflammation of fatty tissue under the skin, skin ulcer, blistering of the skin, nail disorder, hair disorder, hand-foot disorder
• osteonecrosis (a disease of reduced blood flow to the bones, which can cause bone loss and bone death), arthritis, skin swelling anywhere in the body, blue-purple mottling of the skin, difficulty walking
• kidney impairment (including renal failure), increased urination, protein in the urine
• miscarriage
• breast enlargement in men, menstrual disorder
• losing balance while walking, inflammation of the skin blood vessels, skin fibrosis
• raised creatine phosphokinase (an enzyme mainly found in the heart, brain and skeletal muscles), raised gamma-glutamyltransferase (an enzyme mainly found in the liver).

Side effects with unknown frequency:

• recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection)
• an irregular, often rapid heart rate that commonly causes poor blood flow
• clinical syndromes defined by the presence of haemolytic anaemia (destruction of red blood cells), low platelets, and organ damage due to the formation of microscopic blood clots in capillaries and small arteries
• inflammation of the lungs
• bleeding in the stomach or bowels that can cause death
• a reaction with fever, blisters on the skin, and ulceration of the mucous membranes
• disease of the kidneys with symptoms including oedema (build-up of fluid) and abnormal laboratory test results such as protein in the urine and low protein level in the blood.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. Your healthcare provider will monitor your blood counts frequently after you start DASATINIB TEVA and may adjust your dose of DASATINIB TEVA or withhold DASATINIB TEVA temporarily in the event your blood counts drop too low. In some cases, you may need to receive transfusions of red blood cells or platelets. Notify your doctor immediately if you develop a fever while taking DASATINIB TEVA.

Reporting of side effects:

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the ‘6.04 Adverse Drug Reaction Reporting Form’, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DASATINIB TEVA.

Store all medicines out of reach of children.

• Store at or below 25 ºC.
• Store in the original package to protect from moisture.
• Keep the container well closed after first opening.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
• HDPE bottles with 30 film-coated tablets can be used for 1 month after first opening. HDPE bottles with 60 film-coated tablets can be used for 2 months after first opening. HDPE bottles with 100 film-coated tablets can be used for 3 months after first opening.