Brand Name Choices
What Gleevec is and what it is used for
Glivec is a medicine containing an active substance called imatinib. This medicine works by inhibiting
the growth of abnormal cells in the diseases listed below. These include some types of cancer.
Glivec 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. Glivec inhibits the growth of these cells. Glivec 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. Glivec 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. Glivec inhibits the growth of these cells in a certain subtype of these diseases.
•Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.
How to take Gleevec
Your doctor has prescribed Glivec because you suffer from a serious condition. Glivec can help you to
fight this condition.
However, always take this medicine exactly as your doctor or pharmacist has told you. It is important
that you do this as long as your doctor or pharmacist tells you to. Check with your doctor or
pharmacist if you are not sure.
Do not stop taking Glivec unless your doctor tells you to. If you are not able to take the medicine as
your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.
How much Glivec to take
Use in adults
Your doctor will tell you exactly how many tablets of Glivec to take.
•If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg:
•400 mg to be taken as 4 tablets once a day,
•600 mg to be taken as 6 tablets once a day.
•If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 tablets once a day. For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.
•If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 6 tablets once a day.
•If you are being treated for MDS/MPD: The starting dose is 400 mg to be taken as 4 tablets once a day.
•If you are being treated for HES/CEL: The starting dose is 100 mg, to be taken as one tablet once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to treatment.
•If you are being treated for DFSP: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening. Use in children and adolescents The doctor will tell you how many tablets of Glivec to give to your child. The amount of Glivec given will depend on your child’s condition, body weight and height. The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your 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 Glivec
•Take Glivec with a meal. This will help protect you from stomach problems when taking Glivec.
•Swallow the tablets whole with a large glass of water. If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:
• Use about 50 ml for each 100 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Once the tablet has dissolved, drink everything in the glass straight away. Traces of the dissolved tablets may be left behind in the glass. How long to take Glivec Keep taking Glivec every day for as long as your doctor tells you. If you take more Glivec than you should If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you. If you forget to take Glivec
•If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.
•Then continue with your normal schedule.
•Do not take a double dose to make up a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible 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 your doctor straight away if you get 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. Glivec may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Glivec can reduce the number of white blood cells, so you might get infections more easily.
• Unexpected bleeding or bruising (when you have not hurt yourself).
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 your 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 your 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 cellulitis).
• Difficulty hearing.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
• Stomach pain with feeling sick (nausea).
• Muscle spasms with a fever, red-brown urine, pain or weakness in your 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 your 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 calcium levels and low phosphorous levels in the blood).
Not known (frequency cannot be estimated from the available data):
• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection). If you get any of the above, tell your doctor straight away.
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.
• Muscle cramps or joint, muscle or bone pain, during Glivec treatment or after you have stopped taking Glivec.
• Swelling such as round your ankles or puffy eyes.
• Weight gain. If any of these affects you severely, tell your doctor.
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 your abdomen, flatulence, heartburn or constipation.
• 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. If any of these affects you severely, tell your doctor.
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.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents. If any of these affects you severely, tell your doctor.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Ireland: HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
How to Store Gleevec
Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP.
• Do not store above 30°C.
• Store in the original package in order to protect from moisture.
• Do not use any pack that is damaged or shows signs of tampering.
• 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
2 to 3 weeks on average
The average shipping time is 2 weeks in North America and 4 weeks internationally. We offer free shipping on all orders shipped to North America. Shipping is a flat rate of $20.00 for all other countries.
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