nilotinib
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Tasigna.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine.
Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
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 and for two weeks after the last dose 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
heart attack, chest pain (angina), stroke, or leg pain (could be problems with your leg blood flow)
high blood pressure
lower than normal blood levels of potassium or magnesium
high cholesterol or lipid levels in blood
high sugar levels in blood
pancreatitis (inflamed pancreas)
surgical procedure involving the removal of the entire stomach (total gastrectomy)
hepatitis B infection. As during treatment, hepatitis B (an infection of the liver) may become active again.
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, mitozantrone
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, sotalol
medicines that may affect the function of the heart such as chloroquine, halofantrine, haloperidol, methadone, bepridil
alfentanil and fentanyl - used to treat pain and used as a sedative before or during surgery or medical procedure
cyclosporine, sirolimus and tacrolimus - medicines that suppress the "self-defense" ability of the body to fight infections - commonly used to prevent the rejection of transplanted organs such as liver, heart and kidney
dihydroergotamine and ergotamine - medicines used to treat migraine and certain headaches
medicines used to lower cholesterol ("statins") such as simvastatin.
In addition, tell your doctor or pharmacist before taking Tasigna if you are taking antacids (medicines against heartburn) or other medicines that suppress gastric acid secretion. These medications need to be taken separately from Tasigna:
medicines that suppress gastric acid secretion called H2 blockers decrease the production of acids in the stomach. These should be taken approximately 10 hours before and approximately 2 hours after you take Tasigna;
antacids such as those containing aluminum hydroxide, magnesium hydroxide and simethicone neutralize the high acidity of the stomach. These should be taken approximately 2 hours before or approximately 2 hours after you take Tasigna.
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.
If you are unable to swallow capsules, you may mix the content of each capsule in one teaspoon of applesauce (pureed apple) and swallow the mixture immediately.
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.
If your doctor recommends to stop Tasigna
Your doctor will regularly check your treatment with specific monitoring tests. If you have been on Tasigna for 3 years, have achieved a certain response to treatment for at least one year and have a certain type of CML, your doctor may decide whether you should continue or stop taking Tasigna. If you are told to stop taking Tasigna, your doctor will continue to carefully monitor your CML before, during and after cessation. Close monitoring is needed in case you get worse and you may need to re-start Tasigna.
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 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 heartbeat 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.
Call your doctor right away or as soon as possible if you develop chest pain or discomfort, numbness or weakness or problems with walking or talking, or pain, numbness, discoloration or a cool feeling in arms or legs.
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 an effective method of contraception to prevent pregnancy during treatment with Tasigna and for up to two weeks after ending 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.
Tell your doctor if you notice any of the following side effects and they worry you:
abdominal pain, nausea, vomiting
constipation, diarrhoea
headache
tiredness/ lack of energy
muscle pain, pain in joints
itching, rash, dry skin
hair loss
musculoskeletal pain,muscle pain, pain in hand or foot, pain in joints, bone pain and spinal pain upon stopping treatment with Tasigna. These symptoms may be more frequent than prior to your treatment being stopped (refer to If your doctor recommends to stop Tasigna)
upper respiratory tract infections
stomach discomfort after meals, flatulence
bone pain, muscle spasms, muscle weakness
pain including back pain, neck pain and pain in extremity, pain or discomfort in the side of the body
acne, skin wart, decreased skin sensitivity, hives, excessive or night sweating
weight decrease or increase, decreased appetite, disturbed sense of taste
difficulty sleeping, depression, anxiety
voice disorder
nose bleed
urinating frequently
generally feeling unwell
dry mouth, mouth sores
breast pain
gout
increased appetite
erection disorder, breast enlargement in men
flu-like symptoms
sore throat
pneumonia, bronchitis, urinary tract infection
oral or vaginal thrush, herpes virus infection
muscle and joint stiffness, joint swelling
feeling body temperature change (including feeling hot, feeling cold)
sensitivity of teeth
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 or discomfort, high or low blood pressure, irregular heart rhythm (fast or slow), 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 with or without fever
fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
weakness or paralysis of face or limbs, difficulty speaking, severe headache, seeing, feeling or hearing things that are not there, changes in the eyesight, loss of consciousness, confusion, disorientation, trembling, sensation of tingling (pins and needles), pain or numbness in fingers and toes
thirst, dry skin, irritability, dark urine, passing little urine, difficulty or pain in passing urine, urge to urinate frequently, blood in urine, abnormal urine colour
visual disturbances including blurred vision, double vision or perceived flashes of light, decrease sharpness or loss of vision, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching or irritation, dry eye, swelling and itching of the eyelids
swelling and pain in one part of the body
abdominal pain, vomiting blood, black or bloody stools, constipation, heartburn, stomach acid reflux, swelling or bloating of the stomach
severe upper (middle or left) abdominal pain
yellowing of the skin and eyes, nausea, loss of appetite, dark coloured urine
painful red lumps, skin reddening, peeling, blisters or pain
pain in joints and muscles
bulging eyes, fast heartbeat, weight loss, swelling at front of the neck
weight gain, tiredness, hair loss, muscle weakness, feeling cold
dizziness or spinning sensation
excessive thirst, passing large amounts of urine, increased appetite with weight loss, tiredness (signs of a high level of sugar in the blood)
severe headaches often accompanied by nausea, vomiting and sensitivity to light (signs of migraine)
nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory results (such as high potassium, uric acid, and phosphorous levels and low calcium levels in the blood).
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)
fever, skin rash, joint pain and swelling as well as tiredness, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools and dark urine (potential signs of hepatitis B reactivation).
allergy (hypersensitivity to TASIGNA)
hand-foot syndrome (reddening and/or swelling and possibly peeling on the palms and soles), psoriasis (thickened patches of red/silver skin), increased sensitivity of the skin to the light, fungal infection of the feet, skin cyst, skin discolouration, thinning or thickening of the skin and thickening of the outermost layer of the skin)
difficulty hearing, ear pain, noises (ringing) in the ears
joint inflammation
disturbed mood, memory loss
urinary incontinence
enterocolitis (inflammation of the bowel)
haemorrhoids, anal abscess
feeling of hardening in the breast, nipple swelling, heavy periods
bleeding, tender, enlarged gum, oral warts
an urge to move one part of the body (commonly the leg) to stop uncomfortable sensations
Some side effects can only be found when your doctor does tests from time to time to check your progress.
During Tasigna treatment, you may also have some abnormal blood test results such as low level of blood cells (white cells, red cells, platelets), high blood level of lipase or amylase (pancreas function), high blood level of bilirubin (liver function), high blood level of creatinine (kidney function), high level of potassium or low level of magnesium, low or high blood level of Insulin (an enzyme regulating blood sugar level), high level of fats in the blood.
Your heart rate will also be checked using a machine that measures electrical activity of the heart (a test called an "ECG").
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".
The weekly pack contains 2 calendar cards (day time 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
poloxamer
titanium dioxide
gelatin
iron oxide yellow
iron oxide red
printing ink (150 mg - black; 200 mg - red)
