Hemator

Hemator 100 mg capsules are hard gelatine capsules, orange body and cap, size no. 3.
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.
Gastrointestinal stromal tumours (GIST). This is a type of cancer of the stomach and bowels. This cancer affects the tissue that surrounds the stomach and bowels and the cells grow uncontrollably
Hemator works by slowing the growth of abnormal cells. Hemator kills the abnormal cells while leaving normal cells alone.
Patients must be advised to 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.

All directions given by the doctor and pharmacist must be followed carefully.
These instructions may differ from the information contained in this monograph.
If the instructions on the label are not understood, patients must be advised to 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.
For GIST, the usual dose is 400 mg each 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 patient may be directed 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 the patient is 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, the medicine must be taken at about the same time each day.
Taking them at the same time each day will help the patient remember to take them.
How long to take it: Taking Hemator must be continued every day for as long as prescribed.
The doctor will keep a close check on the patient to make sure he/she is still benefiting from treatment.
Forgotten intake: The missed dose must be taken as soon as it is remembered, then the normal schedule must be continued.
A double dose should not be taken to make up for the missed dose.
This may increase the chance of getting an unwanted side effect.
Patients must be advised to ask the doctor or pharmacist if they are not sure what to do.
If the patient is having trouble remembering when to take the medicine, the patient must be advised to ask the pharmacist for some hints.

Patients must be advised to immediately telephone a doctor or go to the Accident and Emergency at the nearest hospital if they think that they or anyone else may have taken too much Hemator. This must be done even if there are no signs of discomfort or poisoning. Telephone numbers for these places must be kept in handy.

Hemator must not be taken 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.

Patients must be advised to inform the doctor if they have ever had any of the following medical problems or procedures: kidney or liver problems; problems with the heart; have had the thyroid gland removed.
Special precautions may be taken 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, weight checks and urine tests can also find side effects before they become serious.
If about to start on any new medicine, patients must be advised to remind the doctor and pharmacist that Hemator is being taken.
Patients must be advised to inform any other doctor, dentist or pharmacist who is treating the patient that Hemator is being taken.
Things the patient must not do: This medicine should not be given to anyone else even if their condition seems to be the same.
Patients must not use it to treat any other complaints unless the doctor tells them to.
Things to be careful of: Patients must 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 a need to take something to treat a headache, cold or other minor aches and pains, patients must be advised to try to avoid taking medicines containing paracetamol (e.g. Panadol, Panadeine, Codral, Tylenol) and to ask the pharmacist to suggest an alternative medicine.
When outdoors, patients must wear protective clothing and use at least a 15+ sunscreen. Sunlamps or tanning beds must not be used.
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, patients must be advised to inform the doctor.
Patients must be careful on 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 Children: Some children and adolescents taking Hemator may have slower than normal growth. Growth will be monitored at regular visits by the doctor.

Using a method of contraception must be made sure to prevent pregnancy during treatment with Hemator and for 15 days after ending treatment. Patients must be advised to inform the doctor immediately if she become pregnant while taking this medicine.
Patients must be advised to inform the doctor if she is 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.
Patients must be advised to inform the doctor if she is 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.

Patients must be advised to inform the doctor or pharmacist as soon as possible if they do not feel well while they are taking Hemator.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. The patients may need medical treatment if they get some of the side effects.
The patients should not be alarmed by these lists of possible side effects. The patients may not experience any of them. Patients must be advised to ask the doctor or pharmacist to answer any questions they may have.
Patients must be advised to inform the doctor if they notice any of the following side effects and worries them: swelling of fingers, eyelids, face or lower legs due to fluid build up (a doctor should be seen 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; musculoskeletal pain after stopping Hemator (including muscle pain, limb pain, joint pain, bone pain and back pain; 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.
Patients must be advised to inform 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); Change in urine or blood in urine, pain in the kidney area, tiredness, loss of appetite, nausea/ vomiting, lack of concentration, headache, cramping, itching (signs of kidney 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); Fever, skin rash, joint pain and swelling as well as tiredness, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools and dark urine (potential signs of hepatitis B reactivation); Fatigue, dizziness, shortness of breath, bruises, gum/nose bleeds, minor cuts that bleed a lot, confusion, sleepiness, seizures, decreased urine, swollen legs, fever (potential signs of thrombotic microangiopathy).
The previously mentioned side effects maybe serious. The patient may need urgent medical attention.
Patients must be advised to inform the doctor if they notice anything else that is making them 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.

Patients must be advised to inform the doctor if they are 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.
Patients may need to take different amounts of these medicines or may need to take different medicines. The doctor and pharmacist have more information.
Patients must be advised to inform the doctor about these things before taking this medicine.

Disposal: If the doctor informs the patient to stop taking this medicine or the expiry date has passed, he/she must be advised to ask the pharmacist what to do with any medicine left over.

Store below 25°C.
Protect from moisture.

Targeted Cancer Therapy

L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.

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