nilotinib
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What Tasigna is used for
Tasigna is used to treat chronic myeloid leukaemia (CML).
CML is a type of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells. Tasigna kills the abnormal cells while leaving normal cells alone.
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.
Tasigna 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 and adolescents under 18 years of age.
Before you take Tasigna
When you must not take it
Do not take Tasigna if you have ever had an allergic reaction to nilotinib (the active ingredient) or to any of the other 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.
Do not take Tasigna after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
In that case, return the medicine to your pharmacist.
Before you start to take it
Tell your doctor if you are pregnant or planning 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.
Tell your doctor if you are breast-feeding. You should not take Tasigna if you are breast-feeding as it may harm your baby.
Tell your doctor if you have ever had any of the following medical problems or procedures:
kidney or liver problems
problems with your heart
lower than normal blood levels of potassium or magnesium
pancreatitis (inflamed pancreas)
surgical procedure involving the removal of the entire stomach (total gastrectomy)
Your doctor may want to take special precautions in that case.
Tell your doctor if you have an intolerance to lactose.
This medicine contains lactose.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Tasigna may interfere with each other. These include:
St. John's wort, a herbal medicine found in many products that you can buy without a prescription
some chemotherapy medicines such as daunorubicin, doxorubicin, epirubicin, mitoxantrone
antibiotic medicines such as rifampicin, erythromycin, clarithromycin, telithromycin, moxifloxacin
antifungal medicines such as ketoconazole, itraconazole, voriconazole
antiviral medicines used to treat HIV/AIDS such as ritonavir
medicines used to treat epilepsy, such as phenytoin, carbamazepine, phenobarbitone
medicines used as sedatives such as midazolam
anti-arrhythmic medicines used to treat irregular heart beat such as amiodarone, disopyramide, procainamide, quinidine, sotalol
medicines that may affect the function of the heart such as chloroquine, halofantrine, haloperidol, methadone, bepridil, pimozide
antacids and other medicines that suppress gastric acid secretion
If an antacid is needed, it should be taken at least 2 hours before or 2 hours after the Tasigna dose.
These medicines should be avoided during your treatment with Tasigna. If you are taking any of these, 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.
How to take Tasigna
Follow all directions given to you by your doctor and pharmacist carefully.
These instructions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How much to take
For patients newly diagnosed with CML, the usual dose is two capsules of 150 mg (300 mg) taken twice a day.
For CML patients no longer benefiting from previous treatment for CML, the usual dose is two capsules of 200 mg (400 mg) taken twice a day.
Two capsules in the morning and two in the evening.
Your doctor may direct you to take a higher or lower dose, depending on your response to Tasigna.
How to take it
Take Tasigna in the morning and the evening, about 12 hours apart.
Tasigna must not be taken with food. Take it at least 2 hours after eating. Do not eat for at least 1 hour after taking it.
This will help you absorb the right amount of medicine to effectively treat your condition.
For example, your day might look a bit like this:
7 am: wake up and take your 1st dose of Tasigna
8 am: breakfast
Usual daily activities
5pm : begin fasting in preparation for your next dose of Tasigna.
7 pm: take your 2nd dose of Tasigna
8 pm: dinner
Take the capsules with a large glass of water.
This will help to avoid irritating the lining of your oesophagus (food pipe) and stomach.
For the best effect, take the capsules 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 Tasigna 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 take it
If you miss a dose, skip the dose you missed and take your next dose as scheduled. Do not take a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
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 take too much (Overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone number 131 126 in Australia or 0800 764 766 in New Zealand) or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Tasigna. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
While you are taking Tasigna
Things you must do
Call your doctor right away or as soon as possible if you have fainted or have an irregular heart beat while taking Tasigna as these may be due to a serious heart condition. Uncommon cases of sudden death have been reported in patients receiving Tasigna.
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, ECG test and weight checks can also find side effects before they become serious.
Make sure you use a method of contraception to prevent pregnancy during treatment with Tasigna. Tell your doctor immediately if you become pregnant while you are taking this medicine.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Tasigna.
Tell any other doctor, dentist or pharmacist who treats you that you are taking Tasigna.
Things you must 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 you to.
Things to be careful of
Do not eat or drink products and juices containing grapefruit, star fruit, pomegranate, seville oranges and other similar fruits at any time while you are being treated with Tasigna.
It may interact with Tasigna and affect how your body uses this medicine.
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Tasigna affects you.
This medicine may cause dizziness or light-headedness 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.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Tasigna.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by these lists of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.
These side effects may be common but are generally mild:
change in skin sensitivity, skin pain
dry mouth, change in appetite, mouth sores, disturbed sense of taste
erectile dysfunction
breast pain, breast enlargement in men
nose bleeds, flu-like symptoms, feeling unwell
anxious, confused, disorientated, sad mood
urinate frequently
eye itching, dry eye
Tell your doctor if you notice any of the following side effects and they worry you:
headache
nausea, constipation, diarrhoea,
vomiting, passing wind or abdominal pain, stomach discomfort after meals
tiredness, difficulty sleeping
rash, itching or redness of the skin, dry skin, acne, skin wart
weight loss or gain
hair loss
excessive sweating, night sweats, hot flushes
voice disorder
bone pain, pain in joints, muscle spasms, muscle pain
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you get any of the following side effects:
chest pain, high blood pressure, irregular heart rhythm, palpitations, fainting, blue discolouration of the lips, gums or skin
rapid weight gain, swelling of face, hands, ankles or feet
difficulty or painful breathing, cough, wheezing,
fever, easy bruising, frequent infections
weakness or paralysis of face or limbs, difficulty speaking, severe headache, seeing, feeling or hearing things that are not there, loss of consciousness, confusion, disorientation, trembling, tingling, pain or numbness in fingers and toes
thirst, dry skin, irritability, dark urine, passing little urine, passing a lot of urine, difficulty or pain in passing urine, blood in urine
blurred vision, loss of vision, blood in eye, increased sensitivity of the eyes to light, eye pain or redness, swelling and itching of the eyelids, decreased sharpness of vision, eye irritation
swelling and pain in one part of the body
severe abdominal pain, vomiting blood, black or bloody stools, heartburn, stomach acid reflux
yellowing of the skin and eyes, dark coloured urine
painful red lumps
bulging eyes, neck swelling
dizziness or spinning sensation
pain or discomfort, weakness, or cramping in leg muscles which may be due to decreased blood flow, ulcers that heal slowly or not at all and noticeable changes in colour (blueness or paleness) or temperature (coolness) as these symptoms could be signs of artery blockage in the affected limb (leg or arm) and digits (toes and fingers)
The above side effects may be serious. You may need urgent medical attention. Serious side effects are generally rare.
Tell your doctor if you notice anything else that is making you 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.
After taking Tasigna
Storage
Keep your medicine in the original container until it is time to take it.
Store it in a cool dry place.
Do not store Tasigna or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Keep the medicine where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
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.
Product description
What it looks like
Tasigna 150 mg is a white to slightly yellowish powder in red opaque hard gelatin capsules, size 1 with black axial imprint "NVR/BCR".
Tasigna 200 mg is a white to slightly yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint "NVR/TKI".
Tasigna is available in 28's (weekly), and 120's (monthly) packs.
The weekly pack contains 2 calendar cards (daytime and night time) of 14 capsules.
The monthly pack consists of 3 packs of 40 capsules.
Ingredients
Tasigna capsules contain 150 mg or 200 mg of nilotinib. Tasigna capsules also contain:
lactose
crospovidone
silica colloidal anhydrous
magnesium stearate
polaxmer
titanium dioxide
gelatin
iron oxide yellow CI77492
iron oxide red CI77491
iron oxide black CI77499
shellac
water-purified
n-butyl alcohol
methylated spirit - industrial (trace amounts used to make ink print)
lecithin
antifoam DC 1510
titanium dioxide
propylene glycol
isopropyl alcohol
Sponsor
Tasigna is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
(ABN 18 004 244 160)
54 Waterloo Road
North Ryde NSW 2113
Telephone 1 800 671 203
Web site: www.novartis.com.au
Tasigna is supplied in New Zealand by:
Novartis New Zealand Limited
6-8 Mackelvie Street
Grey Lynn
Private Bag 47909
Ponsonby
Auckland
Telephone 0800 652 422
= Registered Trademark
This leaflet was prepared in
August 2011
Australian Registration Number
Tasigna 150 mg
AUST R 171498
Tasigna 200 mg
AUST R 133086
