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 TASIGNA?
TASIGNA contains the active ingredient nilotinib. TASIGNA is used to treat chronic
myeloid leukaemia (CML)
2. What should I know before I use TASIGNA?
Do not use if you have ever had an allergic reaction to TASIGNA 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.
3. What if I am taking other medicines?
Some medicines may interfere with TASIGNA and affect how it works.
4. How do I use TASIGNA?
If you have been newly diagnosed with CML the usual dose of TASIGNA is two capsules
of 150 mg (300 mg) twice daily. If you are no longer doing well from previous treatment
for CML, the usual dose is two capsules of 200 mg (400 mg) twice daily.
You should take TASIGNA in the morning and evening, approximately 12 hours apart.
You must not take TASINGA with food. Do not eat at least 2 hours before and 1 hour
after taking TASIGNA.
5. What should I know while using TASIGNA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TASIGNA.
Have regular blood tests, heart and weight checks while using TASIGNA.
Avoid becoming pregnant while using TASIGNA and for 2 weeks after you stop using it.
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Things you should not do
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Do not stop using this medicine suddenly (unless your doctor tells you to).
Do not drink products and juices containing grapefruit juice, star fruit, pomegranate,
seville oranges and other similar fruits while using TASIGNA.
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Driving or using machines
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It is not known if TASIGNA will influence your ability to drive and use machines.
Be cautious when driving or using machines in case you feel dizzy or tired while using
TASIGNA.
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Drinking alcohol
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There are no known interactions between TASIGNA and alcohol.
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Looking after your medicine
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Store below 30°C.
Keep out of reach of children.
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6. Are there any side effects?
Common side effects include headache, decreased appetite, feeling sick, vomiting,
constipation, diarrhoea, tummy pain, rash, hair loss, dry skin, pain in muscles or
joints, tiredness.
Active ingredient(s):
nilotinib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TASIGNA. 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 TASIGNA.
Where to find information in this leaflet:
1. Why am I using TASIGNA?
TASIGNA contains the active ingredient nilotinib. TASIGNA belongs to a group of medicines call tyrosine kinase inhibitors. It kills
cancerous white blood cells that contain a particular kind of tyrosine kinase, while
leaving normal cells alone.
TASIGNA is used to treat chronic myeloid leukaemia (CML). CML is a type of leukaemia.
2. What should I know before I use TASIGNA?
Warnings
Do not use TASIGNA if:
you are allergic to nilotinib, or any of the ingredients listed at the end of this
leaflet. Symptoms of an allergic reaction can include difficulty breathing, wheezing,
swelling of the face, lips or tongue and rash.
Check with your doctor if you:
Have or have had problems with your heart, previous heart attack, or chest pain (angina)
Have lower than normal blood levels of potassium or magnesium
Have high blood cholesterol or lipid levels
Have high blood sugar levels
Have liver or kidney problems
Have had hepatitis B infection
Have had inflammation of the pancreas (pancreatitis)
Have had surgery to remove your entire stomach (total gastrectomy)
Take any medicines for any other condition
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
Talk to your doctor if you are pregnant or intend to become pregnant. TASIGNA may
harm an unborn baby. Your doctor will discuss with you what is best for you and your
baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed. You should not
take TASIGNA if you are breastfeeding and for 2 weeks after your last dose of TASIGNA.
Contraception
You should avoid becoming pregnant while using TASIGNA and for 2 weeks after you stop
using it. Ask your doctor or pharmacist for options of effective birth control.
Use in children
TASIGNA is not recommended for use in children and adolescents under 18 years of age.
It may cause slower than normal growth in some children and adolescents.
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 TASIGNA and affect how it works such as:
St John's Wort, a herbal medicine that you can buy without a prescription
Antibiotic medicines such as clarithromycin, moxifloxacin, rifampicin
Antifungal medicines such as itraconazole, ketoconazole, voriconazole
Antiviral medicines used to treat HIV/AIDS such as ritonavir
Medicines used to treat epilepsy such as carbamazepine, phenobarbital, phenytoin
Medicines used to relax or calm you or help you sleep (sedatives) such as midazolam
Medicines used to treat irregular heart beat such as amiodarone, disopyramide, sotalol
Medicines that may affect the function of the heart such as chloroquine, haloperidol,
methadone
Medicines such as alfentanil and fentanyl, that are used to treat pain or as a sedative
before or during surgery or a medical procedure
Medicines such as ciclosporin, sirolimus and tacrolimus, that decrease the body's
ability to fight infection and are commonly used to prevent rejection of transplanted
organs
Antacids, such as those containing aluminium hydroxide, magnesium hydroxide and simethicone,
neutralise the high acidity of the stomach and should be taken approximately 2 hours
before and approximately 2 hours after you take TASIGNA.
H2 blockers, such as famotidine and nizatidine, should be taken approximately 10 hours
before and approximately 2 hours after you take TASIGNA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TASIGNA.
4. How do I use TASIGNA?
How much to take
If you have been newly diagnosed with CML the usual dose of TASIGNA is two capsules
of 150 mg (300 mg) twice daily.
If you are no longer doing well from previous treatment for CML, the usual dose is
two capsules of 200 mg (400 mg) twice daily.
Follow the instructions provided and use TASIGNA until your doctor tells you to stop.
When to take TASIGNA
TASIGNA should be taken in the morning and evening, approximately 12 hours apart.
TASIGNA must not be taken with food. Do not eat for at least 2 hours before and at
least 1 hour after taking TASIGNA.
How to take TASIGNA
Swallow TASIGNA capsules whole with a large glass of water.
If you are unable to swallow capsules, you may mix the content of each capsule in
one teaspoon of applesauce (pureed apple). Swallow the mixture immediately. Do not
use more than one teaspoon of applesauce and do not use any other food other than
applesauce.
If you forget to take TASIGNA
TASIGNA should be taken regularly at the same time, twice a day. If you miss your
dose at the usual time, take it as soon as you remember and then take the next capsule
as usual.
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 TASIGNA, keep a treatment diary, or ask
your doctor or pharmacist for some hints.
Do not stop taking TASIGNA or change your dose without talking to your doctor.
If you take too much TASIGNA
If you think that you have taken too much TASIGNA, 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 TASIGNA?
Things you should do
Have regular blood tests, heart and weight checks as directed by your doctor.
Avoid becoming pregnant while using TASIGNA and for 2 weeks after you stop using it.
Call your doctor straight away if you:
Become pregnant or think you may be pregnant.
Have fainted or have an irregular heart beat while using TASIGNA.
Develop chest pain or discomfort, numbness or weakness, problems with walking or talking,
or pain, numbness, change in colour or a cool feeling in your arms or legs.
Remind any doctor, dentist or pharmacist you visit that you are using TASIGNA.
Things you should not do
Do not stop using this medicine unless your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Foods and drinks to avoid
Do not eat or drink products and juices that contain grapefruit juice, star fruit,
pomegranate, seville oranges or other similar fruits while you are being treated with
TASIGNA.
Additional tests
Your doctor may do some blood tests such as checking blood cells (white blood cells,
red blood cells and platelets), electrolytes (e.g., potassium and magnesium), sugar
levels and cholesterol or lipid levels in your body from time to time to make sure
TASIGNA is working and to prevent unwanted side effects. Your kidneys, liver, heart,
blood pressure will also be checked regularly.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TASIGNA
affects you.
TASIGNA may cause tiredness in some people.
Drinking alcohol
Tell your doctor if you drink alcohol.
There are no known interactions between TASIGNA with alcohol.
Looking after your medicine
Store below 30°.
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.
If your doctor recommends you stop using TASIGNA
Your doctor will regularly check your treatment with specific monitoring tests.
If you have been taking TASIGNA for 3 years, have achieved a certain response to treatment
for at least 1 year and have a certain type of CML, your doctor may tell you to stop
taking TASIGNA.
Your doctor will continue to monitor your CML. If you get worse, you may need to start
using TASIGNA again.
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.
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
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Less serious side effects
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What to do
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Tummy problems:
Tummy pain or discomfort
Feeling sick
Vomiting
Constipation
Diarrhoea
Wind or gas
Skin problems:
Itching
Rash
Dry skin
Hair loss
Warts
Acne
Eye problems:
Eye infection
Dry eye
General:
Headache
Tiredness/lack of energy
Muscle, bone or joint pain
Pain in hands or feet
Muscle spasms/weakness
Tingling feeling or loss of sensation
Swelling of arms, legs, hands or feet
Upper respiratory tract infections
Depression
Anxiety
Trouble sleeping
Dizziness or light-headed
Hot flushes or night sweats
Frequent wee
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
If these side effects become severe, please tell your doctor, pharmacist or healthcare
provider.
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Serious side effects
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Serious side effects
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What to do
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Heart problems:
Chest pain or discomfort
Irregular heart beat or fast heart beat
Lung problems:
Difficult or painful breathing
Change in colour (blue) of lips, gums or skin
General:
Fever, severe or frequent infections, unexplained bleeding or weakness
Weakness, numbness or paralysis of face, limbs, fingers or toes
Swelling and pain in one part of the body
Severe upper tummy pain
Blurred vision, double vision, decreased sharpness of vision, flashes of light in
the eye, swelling or blood in the eye
Vomiting blood, black or bloody poo, pale poo
Yellowing of the skin and eyes
Difficulty or pain when you wee , need to wee frequently, blood in wee, abnormal wee
colour or cloudy wee
Painful red lumps or blisters on the skin, reddening or peeling of skin, increased
sensitivity of the skin to light, changes in skin colour
Weight gain, loss of appetite, or increased appetite with weight loss, tiredness
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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.
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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.
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 TASIGNA contains
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Active ingredient
(main ingredient)
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Nilotinib
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Other ingredients
(inactive ingredients)
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Lactose
Colloidal anhydrous silica
Crospovidone
Magnesium stearate
Poloxamer
Gelatin
Iron oxide red
Iron oxide yellow
Titanium dioxide
Printing ink (150 mg: black; 200 mg: red)
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Potential allergens
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Galactose
Milk
Sugars as lactose
Sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What TASIGNA looks like
TASIGNA is supplied as capsules in blister packs.
TASIGNA 150 mg capsules contain a white to slightly yellowish powder in red opaque
hard gelatin capsules, size 1 with black axial imprint "NVR/BCR" (AUST R 171498).
TASIGNA 200 mg capsules contain a white to slightly yellowish powder in light yellow
opaque hard gelatin capsules, size 0 with red axial imprint "NVR/TKI" (AUST R 133086).
TASIGNA 150 mg and 200 mg capsules are available in packs of 28 capsules (weekly)*
and 120 capsules (monthly). The weekly pack contains 14 capsules on 2 calendar cards
(day time and night time). The monthly pack contains 3 packs of 40 capsules.
*Not all pack sizes may be marketed.
Who distributes TASIGNA
TASIGNA is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1 800 671 203
TASIGNA is supplied in New Zealand by:
NOVARTIS New Zealand Ltd
PO Box 99102, Newmarket
Auckland 1149, New Zealand
Telephone: 0800 354 335
® = Registered Trademark
© Copyright 2021.
This leaflet was prepared in March 2024.
Internal document code:
(tas211022c_v2.doc based on PI tas211022i.doc)