Imakrebin

Imakrebin

imatinib

Manufacturer:

Alvogen

Distributor:

International Med
Full Prescribing Info
Contents
Imatinib.
Description
Each Imakrebin film-coated tablet 100 mg contains 100 mg imatinib (as mesilate).
Excipients/Inactive Ingredients: Microcrystalline cellulose, low substituted hydroxypropyl cellulose, povidone, crospovidone (Type A), silica colloidal anhydrous, magnesium stearate.
The tablet coating is made of hypromellose, polyethylene glycol, talc, red iron oxide (E172), yellow iron oxide (E172).
Indications/Uses
Imakrebin is a treatment for adults and children for: Chronic myeloid leukaemia (CML): Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL): Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imakrebin inhibits the growth of these cells.
Imakrebin is also a treatment for adults for: Myelodysplastic/myeloproliferative diseases (MDS/MPD): These are a group of blood diseases in which some blood cells start growing out of control. Imakrebin inhibits the growth of these cells in a certain subtype of these diseases.
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. Imakrebin inhibits the growth of these cells in a certain subtype of these diseases.
Dermatofibrosarcoma protuberans (DFSP): DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imakrebin inhibits the growth of these cells.
Dosage/Direction for Use
Always take this medicine exactly as prescribed. Check with the doctor or pharmacist if the patient is not sure.
Do not stop taking Imakrebin unless the doctor tells the patient to.
How much Imakrebin to take: Use in adults: The doctor will tell the patient exactly how many tablets of Imakrebin to take.
Use in children and adolescents: The doctor will tell the patient how many tablets of Imakrebin to take. The amount of Imakrebin given will depend on the child's condition, body weight and height. The total daily dose in children must not exceed 800 mg. The treatment can either be given to the child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).
When and how to take Imakrebin: Take Imakrebin with a meal. This will help protect the patient from stomach problems when taking Imakrebin.
Swallow the tablets whole with a large glass of water.
If the patient is unable to swallow the tablets, dissolve them in a glass of still water or apple juice.
How long to take Imakrebin: Keep taking Imakrebin every day for as long as the doctor tells the patient.
If the patient takes more Imakrebin than he/she should: If the patient has accidentally taken too many tablets, talk to the doctor straight away. This may require medical attention.
If the patient forgets to take Imakrebin: If the patient forgets a dose, take it as soon as remembered. However if it is nearly time for the next dose, skip the missed dose, then continue with the normal schedule. Do not take a double dose to make up a forgotten dose.
If the patient has any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.
Contraindications
Do not take Imakrebin: if the patient is allergic to imatinib or any of the other ingredients of this medicine (listed in Description).
Warnings
Imakrebin is not to be used for the treatment of GIST.
Special Precautions
Talk to a doctor before taking Imakrebin.
If the patient has or had a liver, kidney or heart problem.
If the patient is taking the medicine levothyroxine because the thyroid has been removed.
During treatment with Imakrebin, tell the doctor straight away if the patient puts on weight very quickly. Imakrebin may cause the body to retain water (severe fluid retention).
While the patient is taking Imakrebin, the doctor will regularly check whether the medicine is working. The patient will also have blood tests and be weighed regularly.
Driving and Using Machines: The patient may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until the patient is feeling well again.
Pregnancy, breast-feeding and fertility: If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor for advice before taking this medicine.
Imakrebin is not recommended during pregnancy unless clearly necessary as it may harm the baby. The doctor will discuss with the patient the possible risks of taking Imakrebin during pregnancy.
Women who might become pregnant are advised to use effective contraception during treatment.
Do not breast-feed during the treatment with Imakrebin.
Patients who are concerned about their fertility while taking Imakrebin are advised to consult with their doctor.
Children and adolescents: Imakrebin is also a treatment for children with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Some children and adolescents taking Imakrebin may have slower than normal growth. The doctor will monitor the growth at regular visits.
Use In Pregnancy & Lactation
Pregnancy, breast-feeding and fertility: If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor for advice before taking this medicine.
Imakrebin is not recommended during pregnancy unless clearly necessary as it may harm the baby. The doctor will discuss with the patient the possible risks of taking Imakrebin during pregnancy.
Women who might become pregnant are advised to use effective contraception during treatment.
Do not breast-feed during the treatment with Imakrebin.
Patients who are concerned about their fertility while taking Imakrebin are advised to consult with their doctor.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.
Some side effects may be serious. Tell the doctor straight away if the patient gets any of the following: Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): Rapid weight gain. Imakrebin may cause your body to retain water (severe fluid retention).
Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imakrebin can reduce the number of white blood cells, so the patient might get infections more easily.
Unexpected bleeding or bruising.
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Chest pain, irregular heart rhythm (signs of heart problems).
Cough, having difficulty breathing or painful breathing (signs of lung problems).
Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
Severe abdominal pain, blood in the vomit, stools or urine, black stools (signs of gastrointestinal disorders).
Severely decreased urine output, feeling thirsty (signs of kidney problems).
Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
Eye pain or deterioration in vision, bleeding in the eyes.
Pain in the hips or difficulty walking.
Numb or cold toes and fingers (signs of Raynaud's syndrome).
Sudden swelling and redness of the skin (signs of a skin infection called cellulites).
Difficulty hearing.
Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in the blood).
Bruising.
Stomach pain with feeling sick (nausea).
Muscle spasms with a fever, red-brown urine, pain or weakness in the muscles (signs of muscle problems).
Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with the ovaries or womb).
Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg. high potassium, uric acid and phosphorous levels and low calcium levels in the blood).
Other side effects may include: Very common (may affect more than 1 in 10 people): Headache or feeling tired; feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion; rash; muscle cramps or joint, muscle or bone pain; swelling such as round the ankles or puffy eyes; weight gain.
Common (may affect up to 1 in 10 people): Anorexia, weight loss or a disturbed sense of taste; feeling dizzy or weak; difficulty in sleeping (insomnia); discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision; nose bleeds; pain or swelling in the abdomen, flatulence, heartburn or constipation; itching; unusual hair loss or thinning; numbness of the hands or feet; mouth ulcers; joint pain with swelling; dry mouth, dry skin or dry eye; decreased or increased skin sensitivity; hot flushes, chills or night sweats.
Not known (frequency cannot be estimated from the available data): 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.
Drug Interactions
Other medicines and Imakrebin: Tell the doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John's Wort). Some medicines can interfere with the effect of Imakrebin when taken together. They may increase or decrease the effect of Imakrebin, either leading to increased side effects or making Imakrebin less effective. Imakrebin may do the same to some other medicines.
Tell the doctor if the patient is using medicines that prevent the formation of blood clots.
Storage
Do not store above 30°C. Protect from moisture.
ATC Classification
L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
FC tab 100 mg x 120's.
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