Dasamia Film-Coated Tablets

DASAMIA contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukaemia (CML) in adults. Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. In people with CML, white cells called granulocytes start growing out of control. DASAMIA inhibits the growth of these leukaemic cells.

DASAMIA is also used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML in adults who are not benefiting from prior therapies. In people with ALL, white cells called lymphocytes multiply too quickly and live too long. DASAMIA inhibits the growth of these leukemic cells.

Do not take DASAMIA:

• If you are hypersensitive (allergic) to dasatinib or any of the other ingredients of this medicine (listed in section 6).
• Using H2 blockers or proton pump inhibitors with DASAMIA is not recommended.

Warnings and precautions

Special care should be taken with DASAMIA

• If you are taking medicines to thin the blood or prevent clots (see " Other medicines and DASAMIA ").
• if you have problems with your immune system
• If you have a liver problem
• If you have a heart problem, including a condition called congenital long QT syndrome.
• If you start having difficulty breathing, chest pain, or a cough when taking DASAMIA: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older), or due to changes in the blood vessels supplying the lungs.
• If you have ever had or might now have a hepatitis B infection. This is because DASAMIA 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 experience bruising, bleeding, fever, fatigue and confusion when taking DASAMIA, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
• If you have a history of skin problems.

Cerebrovascular events (conditions that affect blood flow to your brain) including stroke and brain bleed have been reported with the use of this medicines (see Possible Side Effects).

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

Children and adolescents

Dasatinib has not been studied in children.

Other medicines and DASAMIA

Always tell your healthcare professional if you are taking any other medicine (This includes complementary or traditional medicines). DASAMIA is mainly handled by the liver. Certain medicines may interfere with the effect of DASAMIA when taken together.

These medicines are not to be used with DASAMIA:

• ketoconazole, itraconazole - these are antifungal medicines
• erythromycin, clarithromycin, telithromycin - these are antibiotics
• ritonavir, atazanavir, indinavir, nelfinavir, saquinqvir - these are antiviral medicines
• dexamethasone – a corticosteroid medicine
• phenytoin, carbamazepine, phenobarbital - these are treatments for epilepsy
• rifampicin - this is a treatment for tuberculosis
• famotidine, omeprazole - these are medicines that block stomach acids
• St. John’s wort - a herbal preparation obtained without a prescription, used to treat depression

Do not take medicines that neutralise stomach acids (antacids such as aluminium hydroxide or magnesium hydroxide) in the 2 hours before or 2 hours after taking DASAMIA.

Tell your doctor if you are taking medicines to thin the blood or prevent clots.

DASAMIA with food and drink

Do not drink grapefruit juice when you are taking DASAMIA.

Do not share medicines prescribed for you with any other person. Always take DASAMIA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose for DASAMIA in patients with chronic phase CML is 100 mg once daily, with or without a meal. The recommended starting dose for DASAMIA 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 DASAMIA at the same time each day.

Swallow DASAMIA 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 DASAMIA upward or downward, or may temporarily discontinue DASAMIA. Your doctor will tell you how long your treatment with DASAMIA will last.

You should not change your dose or stop taking DASAMIA without first talking with your healthcare provider.

If you take more DASAMIA 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 DASAMIA

Do not take a double dose to make up for a forgotten tablet. Take the next scheduled dose at the regular time.

If you stop taking DASAMIA

Do not stop taking your medicine without consulting your doctor.

DASAMIA can have side effects. Not all side effects reported for DASAMIA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DASAMIA please consult your health care provider for advice.

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

• Severe potentially life-threatening allergic reactions symptoms include red-purple swellings on the shins, thighs and, less commonly, the arms. Joint and muscle pains and fever may also occur (anaphylactic shock)
• Rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson Syndrome)
• Redness, swelling, and pain on the palms of the hands and/or the soles of the feet, sometimes blisters appear (palmar-plantar erythrodysesthesia syndrome)
• Hypersensitivity (allergic) reactions including skin rash with red lumps
• Severe condition of the skin that may affect the mouth and other parts of the body symptoms include red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body. The spots may blister or may progress to form raised, red, pale-centred marks. Those affected may have fever, sore throat, headache and/or diarrhoea (erythema multiforme)
• Unexpected bleeding or bruising without having an injury
• Gastro-intestinal bleeding, blood in your vomit, stools or urine, or have black stools

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

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

Frequent side effects

• Chest pain, difficulty breathing, shortness of breath, coughing, wheezing and fainting which may be due to swelling of lungs (pneumonitis) or blood clots in the lungs (pulmonary embolism) or accumulation of fluid between the tissues that line the lungs and the chest (pleural effusion, dyspnoea)
• Tiredness, headaches, dizziness, being short of breath when exercising and looking pale, frequent infections such as fever, severe chills, sore throat or mouth ulcers bleeding or bruising more easily than normal which may be due to a disease of the blood with a reduced number of red or white blood cells or platelets (myelosuppression)
• Serious lung infection with fever, chills, cough, phlegm and occasionally blood (pneumonia), herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infection, serious infection of the blood or tissues (including uncommon cases with fatal outcomes).
• Infection, fever with decrease in the number of a type of white blood cell in the blood (febrile neutropenia)

Less frequent side effects

• Headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness (CNS bleeding)
• Fatigue, lethargy, and/or abnormal paleness of the skin (pallor) due to anemia, a rare disorder of blood production in which the bone marrow, the spongy tissue in the center of the bones, fails to function in an adequate manner (aplasia pure red cell)

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

Digestive problems

• Diarrhoea, feeling or being sick (nausea, vomiting)

Pain

• Pain in the muscles (during or after discontinuing treatment), tummy (abdominal) pain

General disorders

• Swelling around the face, hands and feet, headache, feeling tired or weak

Heart and lungs

• Palpitations, irregular heartbeat
• Congestive heart failure
• Weak heart muscle
• High blood pressure
• Increased blood pressure in the lungs

Digestive problems

• Appetite disturbances, high uric acid levels in the blood, which may cause gout (hyperuricaemia)
• Taste disturbance
• Bloated or distended tummy (abdomen)
• Inflammation of the colon
• Constipation, heartburn, mouth ulceration
• Weight increase, weight decrease
• Inflammation or irritation of the lining of the stomach

Skin, hair, eye, general

• Skin tingling
• Allergic reaction including tender, red lumps on the skin (erythema nodosum)
• Itchy rashes(urticaria), dry skin, acne, inflammation of the skin
• Persistent noise in ears

Store at or below 25 ⁰C in original package. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.