SUMMARY CMI
Imatinib GH
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Imatinib GH?
Imatinib GH contains the active ingredient imatinib mesilate. Imatinib GH is used to treat adults who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL).
Imatinib GH is also used to treat adults for myelodysplastic/myeloproliferative diseases (MDS/MPD), aggressive systemic mastocytosis (ASM), hypereosinophilic syndrome (HES) and or chronic eosinophilic leukaemia (CEL) and for dermatofibrosarcoma protuberans (DFSP). For more information, see Section 1. Why am I using Imatinib GH? in the full CMI.
2. What should I know before I use Imatinib GH?
Do not use if you have ever had an allergic reaction to Imatinib GH or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Imatinib GH? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Imatinib GH and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use Imatinib GH?
For CML, the usual dose for an adult is 400 to 600 mg each day. For Ph-positive ALL the usual dose is 600 mg each day. For MDS/MPD, the starting dose is 400 mg. For ASM and 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.
More instructions can be found in Section 4. How do I use Imatinib GH? in the full CMI.
5. What should I know while using Imatinib GH?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using Imatinib GH? in the full CMI.
6. Are there any side effects?
Serious side effect includes severe allergic reaction, water retention, low level of blood cells, signs of breakdown of red blood cells, pain and having difficulty walking, lung infections, changes in level of potassium in the blood, muscle spasms, severe abdominal pain, low intake of fluids, nosebleeds, vision impairment, yellowing of skin or eyes, changes in urine, severe rash, red skin, cellulitis, sudden loss of consciousness, fits, clots in blood vessels, heart attack, changes in level of potassium, uric acid, phosphorous and calcium in the blood, unexpected vaginal bleeding, dizziness, blurred vision, pale stools, minor cuts that bleed a lot, confusion and sleepiness.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
Imatinib GH
Active ingredient(s): Imatinib mesilate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Imatinib GH. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Imatinib GH.
Where to find information in this leaflet:
1. Why am I using Imatinib GH?
2. What should I know before I use Imatinib GH?
3. What if I am taking other medicines?
4. How do I use Imatinib GH?
5. What should I know while using Imatinib GH?
6. Are there any side effects?
7. Product details
1. Why am I using Imatinib GH?
Imatinib GH contains the active ingredient Imatinib mesilate. Imatinib GH works by slowing the growth of abnormal cells. Imatinib GH kills the abnormal cells while leaving normal cells alone.
Imatinib GH is used to treat adults who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL).
CML and Ph-positive ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells. Imatinib GH kills the abnormal cells while leaving normal cells alone.
Imatinib GH 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.
- Aggressive systemic mastocytosis (ASM). It is a cancer in which certain blood cells, called "mast" cells, grow 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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another purpose.
2. What should I know before I use Imatinib GH?
Warnings
Do not use Imatinib GH if:
- you are allergic to imatinib, or any of the ingredients listed at the end of this leaflet.
- 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.
Always check the ingredients to make sure you can use this medicine.
- you are using it for children under 3 years of age. There is not enough information to recommend the use of Imatinib GH in children under 3 years of age for most uses. For use in CML, there is no experience with the use of Imatinib GH 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 Imatinib GH in children below 1 year of age.
Check with your doctor if you:
- have kidney or liver problems
- have problems with your heart
- had your thyroid gland removed
- have hepatitis B infection. As during treatment with Imatinib GH, hepatitis B (an infection of the liver) may become active again.
Your doctor may want to take special precautions in that case.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
This medicine may be harmful to your unborn baby. If it is necessary for you to take it during pregnancy, your doctor will discuss with you the risks and benefits involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if the active ingredient, imatinib, passes into the breast milk. Because this medicine could affect your baby, breastfeeding is not recommended.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Imatinib GH and affect how it works. These include many medicines that are eliminated from the body through the liver e.g.
- St. John's wort, a herbal medicine found in many products that you can buy 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 Imatinib GH.
- 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
- cyclosporine
You may need to take different amounts of these medicines or you may need to take different medicines. Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/her before you start taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Imatinib GH.
4. How do I use Imatinib GH?
How much to take
- Follow the instructions provided and use Imatinib GH until your doctor tells you to stop.
- If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
- 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 you have.
- 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 ASM and 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.
There is no lower dose (50 mg) of IMATINIB GH available. If a 50 mg dose of imatinib is required, an alternative product must be used.
Your doctor may direct you to take a higher or lower dose, or stop treatment if needed depending on your response to Imatinib GH.
When to take Imatinib GH
- Imatinib GH is usually taken as a single dose each day. However, your doctor may want you to take them in two doses, one in the morning and one in the evening.
How to take Imatinib GH
- Take the medicine with a large glass of water and food.
- This will help to avoid irritating the lining of your oesophagus (food pipe) and stomach.
- If you have difficulty in swallowing:
- If you are unable to swallow the capsules, you can open the capsule and pour the powder capsule contents into a glass of still water or apple juice at room temperature (50 mL for 100 mg capsule or 200 mL for 400 mg capsule) and stir with a spoon.
- The mixture should be taken immediately after complete mixing of the capsule contents in the water or apple juice. - You should handle the capsule contents with caution in order to avoid skin-eye contact or inhalation.
- Women who are pregnant or likely to become pregnant should also handle the contents with caution in order to avoid skin-eye contact or inhalation.
- You should wash your hands immediately after opening the capsules.
- For the best effect, take the medicine at about the same time each day.
- Taking them at the same time each day will help you to remember to take them.
How long to take it
Continue taking Imatinib GH every day for as long as your doctor prescribes.
Your doctor will keep a close check on you to make sure you are still benefiting from treatment.
If you forget to use Imatinib GH
Imatinib GH should be used regularly at the same time each day. If you miss your dose at the usual time then, take the missed dose as soon as you remember, then continue with your normal schedule
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you use too much Imatinib GH
If you think that you have used too much Imatinib GH, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Imatinib GH?
Things you should do
Make sure you follow your doctor's instructions carefully and keep all appointments.
You 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.
Call your doctor straight away if you:
- feel you have slower than normal growth. Some children and adolescents taking Imatinib GH may have slower than normal growth. Growth will be monitored at regular visits by your doctor.
- become pregnant while you are taking this medicine. Make sure you use a method of contraception to prevent pregnancy during treatment with Imatinib GH and for 15 days after ending treatment.
Remind any doctor, dentist or pharmacist when you visit that you are using Imatinib GH.
Things you should not do
- Do not give this medicine to anyone else even if their condition seems to be the same as yours.
- Do not use it to treat any other complaints unless your doctor tells youto.
- Avoid drinking grapefruit juice while you are being treated with Imatinib GH.
Grapefruit juice may interact with Imatinib GH and affect how your body uses this medicine. - If you 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 your pharmacist to suggest an alternative medicine.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Imatinib GH affects you.
This medicine may cause dizziness, light-headedness or drowsiness in some people. Make sure you know how you react to it before you drive a car, operate machinery or do anything that could be dangerous.
When you are outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use a sunlamp or tanning beds.
This medicine may cause your 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 your skin does appear to be burning, tell your doctor.
Looking after your medicine
- Keep your medicine in the original container until it is time to take it.
- A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
More broad or affecting different parts of the body:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
More broad or affecting different parts of the body:
| The above side effects may be serious. You may need urgent medical attention. Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects can only be found by laboratory testing.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Imatinib GH contains
Active ingredient (main ingredient) | imatinib mesilate |
Other ingredients (inactive ingredients) | The other ingredients are:
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Do not take this medicine if you are allergic to any of these ingredients.
What Imatinib GH looks like
Imatinib GH 100 mg capsules are light yellow granules filled in size 3 hard gelatin capsule with brown cap and white body (AUST R 281535).
Imatinib GH 400 mg capsules are light yellow granules filled in size 00EL hard gelatin capsules with brown cap and brown body (AUST R 281536).
Who distributes Imatinib GH
Generic Health Pty Ltd
Level 1, 1102 Toorak Road
CAMBERWELL VIC 3124
[email protected]
Phone no: 1 800 569 074
This leaflet was prepared in October 2021.
Published by MIMS March 2022