Hemator 100 mg capsules contain 100 mg of imatinib.
Excipients/Inactive Ingredients: Capsule content: crospovidone, lactose monohydrate, and magnesium stearate.
Capsule shell: gelatin, yellow iron oxide (E172), titanium dioxide (E171), and red iron oxide (E172).
Hemator is used to treat adults and children/adolescents who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL).
CML and ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells.
Hemator kills the abnormal cells while leaving normal cells alone.
Hemator is also used to treat adults for: Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control.
Hypereosinophilic syndrome (HES) and or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells, named "eosinophils", start growing out of control.
Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.
Hemator works by slowing the growth of abnormal cells. Hemator kills the abnormal cells while leaving normal cells alone.
Not to be used for treatment of GIST (gastro-intestinal stromal tumours).
Ask the doctor if there are any questions about why this medicine has been prescribed.
The doctor may have prescribed it for another purpose.
Hemator is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend the use of this medicine in children under 3 years of age. For use in CML, there is no experience with the use of Hemator in children below 2 years of age. For acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL), there is no experience with the use of Hemator in children below 1 year of age.
Follow all directions given by the doctor and pharmacist carefully.
These instructions may differ from the information contained in this monograph.
If the instructions on the label are not understood, ask the doctor or pharmacist for help.
How much to take: For CML, the usual dose for an adult is 400 to 600 mg each day and the maximum dose is 800 mg each day. The dose depends on what stage of CML the patient has. For Ph-positive ALL the usual dose is 600 mg each day. For children treated with CML and Ph-positive ALL, the dose depends on the size of the child.
For MDS/MPD, the starting dose is 400 mg.
For HES/CEL, the usual starting dose is 400 mg. For some patients the starting dose may be 100 mg.
For DFSP, the starting dose is 800 mg per day.
Daily dose of 400 mg should be taken as one capsule of 400 mg once a day.
Daily dose of 600 mg should be taken as either: six capsules of 100 mg; or one capsule of 400 mg plus two 100 mg capsules once a day.
Daily dose of 800 mg should be taken as 400 mg twice a day, in the morning and in the evening.
The doctor may direct the patient to take a higher or lower dose, or stop treatment if needed depending on the response to Hemator.
Hemator is usually taken as a single dose each day. However, the doctor may want the patient to take them in two doses, one in the morning and one in the evening.
How to take it: Take the medicine with a large glass of water and food.
This will help to avoid irritating the lining of the oesophagus (food pipe) and stomach.
If unable to swallow the capsules: Put the content of the required capsule(s) in a glass of water or apple juice (approximately 50 ml for a 100 mg capsule and 200 ml for a 400 mg capsule).
Stir with a spoon to completely disintegrate the contents.
Immediately drink the whole contents of the glass.
For the best effect, take the medicine at about the same time each day.
Taking them at the same time each day will help remember to take them.
How long to take it: Continue taking Hemator every day for as long as the doctor prescribes.
The doctor will keep a close check on the patient to make sure he/she is still benefiting from treatment.
If the patient forgets to take it: Take the missed dose as soon as it is remembered, then continue with the normal schedule.
Do not take a double dose to make up for the missed dose.
This may increase the chance of getting an unwanted side effect.
If not sure what to do, ask the doctor or pharmacist.
If having trouble remembering when to take the medicine, ask the pharmacist for some hints.
Immediately telephone the doctor or go to the Accident and Emergency at the nearest hospital if the patient thinks that he/she or anyone else may have taken too much Hemator. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
Do not take Hemator if the patient has ever had an allergic reaction to imatinib (the active ingredient) or to any of the other ingredients listed in Description.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Tell the doctor if the patient has ever had any of the following medical problems or procedures: kidney or liver problems; problems with the heart; have had the thyroid gland removed.
The doctor may want to take special precautions in that case.
Hepatitis B virus reactivation: Reactivation of hepatitis B virus (HBV) has occurred in patients who are chronic carriers of this virus after receiving a BCR-ABL tyrosine kinase inhibitor (TKI), including Hemator. Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or death.
Patients should be tested for HBV infection before initiating treatment with Hemator. Patients currently on Hemator should have baseline testing for HBV infection in order to identify chronic carriers of the virus. Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive HBV serology (including those with active disease) and for patients who test positive for HBV infection during treatment. Carriers of HBV who require treatment with Hemator should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Things the patient must do: Make sure to follow the doctor's instructions carefully and keep all appointments.
The patient will need regular follow-up to make sure the treatment is working. Regular blood tests and weight checks can also find side effects before they become serious.
Some children and adolescents taking Hemator may have slower than normal growth. Growth will be monitored at regular visits by the doctor.
Make sure to use a method of contraception to prevent pregnancy during treatment with Hemator. Tell the doctor immediately if the patient became pregnant while taking this medicine.
If about to start on any new medicine, remind the doctor and pharmacist that Hemator is being taken.
Tell any other doctor, dentist or pharmacist who is treating the patient that Hemator is being taken.
Things the patient must not do: Do not give this medicine to anyone else even if their condition seems to be the same.
Do not use it to treat any other complaints unless the doctor tells to.
Things to be careful of: Avoid drinking grapefruit juice while being treated with Hemator. Grapefruit juice may interact with Hemator and affect how the body uses this medicine.
If there is need to take something to treat a headache, cold or other minor aches and pains, try to avoid taking medicines containing paracetamol (e.g. Panadol, Panadeine, Codral, Tylenol). Ask the pharmacist to suggest an alternative medicine.
When outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use a sunlamp.
This medicine may cause the skin to be much more sensitive to sunlight than it normally is.
Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If the skin does appear to be burning, tell the doctor.
Be careful driving, operating machinery or doing jobs that require to be alert until it is known how Hemator affects the patient.
This medicine may cause dizziness, light-headedness or drowsiness in some people. Make sure to know how the patient reacts to it before he/she drives a car, operates machinery or does anything that could be dangerous.
Use in Pregnancy: Tell the doctor if pregnant or planning to become pregnant.
This medicine may be harmful to the unborn baby. If it is necessary to take it during pregnancy, the doctor will discuss the risks and benefits involved.
If women of childbearing potential and under treatment with Hemator, please use effective contraception.
Use in Lactation: Tell the doctor if breast-feeding.
It is not known if the active ingredient, imatinib, passes into the breast milk. Because this medicine could affect the baby, breast-feeding is not recommended.
Tell the doctor if pregnant or planning to become pregnant.
This medicine may be harmful to the unborn baby. If it is necessary to take it during pregnancy, the doctor will discuss the risks and benefits involved.
If women of childbearing potential and under treatment with Hemator, please use effective contraception.
Tell the doctor if breast-feeding.
It is not known if the active ingredient, imatinib, passes into the breast milk. Because this medicine could affect the baby, breast-feeding is not recommended.
Tell the doctor or pharmacist as soon as possible if the patient does not feel well while he/she is taking Hemator.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. The patient may need medical treatment if he/she gets some of the side effects.
Do not be alarmed by these lists of possible side effects. The patient may not experience any of them. Ask the doctor or pharmacist to answer any questions the patient may have.
Tell the doctor if the patient notices any of the following side effects and worries him/her: swelling of fingers, eyelids, face or lower legs due to fluid build up (see the doctor immediately if fluid build up is severe); indigestion, upset stomach, wind, feeling of bloating; nausea (feeling sick) or vomiting; diarrhoea; constipation; dry mouth; swelling, aching, cramping or stiffness in joints or muscles; pain in the bones or along veins; headache; dizziness, light-headedness or vertigo (spinning sensation); tiredness, weakness, feeling generally unwell; numbness, coldness or tingling in fingers and toes; difficulty sleeping, feeling anxious, depressed, confused or forgetful; change in sense of taste; rash, eczema, itching, dry skin, darkening or lightening of skin; symptoms of sunburn (such as redness, itching, swelling or blistering of the skin) which happens more quickly than normal; irritated, red, runny or itchy eyes, blurred vision; ringing in the ears; changes in appetite and weight; hair loss; sweating during the night; throat pain; cough or cold symptoms; loss of interest in sex, problems with sexual function; breast enlargement, nipple pain, painful periods; reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain; slowing of growth in children and adolescents.
Tell the doctor immediately if the patient gets any of the following side effects: severe allergic reaction that can result in difficulty breathing, dizziness; rapid weight gain, swelling of the extremities (calves, ankles), generalised swelling such as swelling of the face (signs of water retention); weakness, spontaneous bleeding or bruising, frequent infections with signs such as fever, chills, swollen glands, sore throat or mouth ulcers (signs of low level of blood cells); Pale skin, tiredness, breathlessness, dark urine (signs of break down of red blood cells); Pain and having difficulty walking; Cough, difficult or painful breathing, wheezing, pain in chest when breathing (signs of lung infections/disorders); Muscle weakness, muscle spasms, abnormal heart rhythm (signs of changes in level of potassium in the blood); Muscle spasms, fever, red-brown urine, kidney disorders, pain or weakness in muscles (signs of muscle disorders); severe abdominal pain, vomiting blood, black or bloody stools, swelling of the abdomen/fluid within the abdomen, constipation, stomach pain (signs of gastrointestinal disorders); thirst, weight loss and severely decreased urine output (signs of low intake of drinks/fluids); nosebleeds or any other unusual bleeding; vision impairment, blurred vision, blood in eye; Nausea, loss of appetite, dark-coloured urine or yellowing of the skin or eyes (signs of liver disorders); nausea, diarrhoea, vomiting, abdominal pain, fever (signs of inflammatory bowel disease); Severe rash, red skin, blistering of the lips, eyes, skin or mouth, skin peeling, fever, red raised or purple skin patches, itching, burning, pustular eruption (signs of skin disorder); severe skin rash, itching, hives, blisters or peeling skin, which may be accompanied by fever, chills, headache, swollen glands, stomach pain or aching joints and muscles; Inflammation of the skin caused by an infection (sign of cellulitis); blood in the urine; severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system disorder such as bleeding or swelling in the brain); seizures (fits); swelling and pain in one part of the body (signs that clots in blood vessels); crushing chest pain, fever, tiredness, irregular heart beat (signs of heart disorders such as heart attack, angina); muscle weakness, muscle spasms, abnormal heart rhythm (signs of changes in level of potassium in the blood); pelvic pain sometimes accompanied by nausea and vomiting, unexpected vaginal bleeding, (signs of gynaecological disorder); nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory (such as high potassium, uric acid, and phosphorous levels and low calcium levels in the blood); Severe headache, dizziness, blurred vision (signs of increased pressure inside skull).
The previously mentioned side effects may be serious. The patient may need urgent medical attention.
Tell the doctor if the patient notices anything else that is making him/her feel unwell.
Other side effects not listed here or not yet known may happen in some people. Some of these side effects can only be found by laboratory testing.
Tell the doctor if the patient is taking any other medicines, including medicines that are bought without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Hemator may interfere with each other. These include many medicines that are eliminated from the body through the liver: St. John's wort, a herbal medicine found in many products that can be bought without a prescription.
Paracetamol, a medicine found in many common pain relievers and cold remedies (e.g. Panadol, Panadeine, Codral, Tylenol) which are known to be associated with liver toxicity. A patient, who was taking paracetamol regularly for fever, died of acute liver failure. Although the cause is currently unknown, special caution should be exercised when using paracetamol and Hemator.
Antibiotic medicines such as rifampicin, ketoconazole, erythromycin, clarithromycin, itraconazole.
Antiviral medicines used to treat HIV/AIDS.
Dexamethasone, a steroid medicine.
Medicines for high cholesterol, such as simvastatin.
Medicines used to treat epilepsy, such as phenytoin, carbamazepine, phenobarbitone.
Warfarin, a medicine used to prevent blood clots.
Some medicines used to treat mental disorders and depression.
Some medicines used to treat high blood pressure and heart problems.
Cyclosporin.
The patient may need to take different amounts of these medicines or the patient may need to take different medicines. The doctor and pharmacist have more information.
Tell the doctor about these things before taking this medicine.
Disposal: If the doctor tells to stop taking this medicine or the expiry date has passed, ask the pharmacist what to do with any medicine left over.
Store below 25°C.
Protect from moisture.
L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
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