Iclusig
ponatinib
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Iclusig is and what it is used for
What you need to know before you take Iclusig
How to take Iclusig
Possible side effects
How to store Iclusig
Contents of the pack and other information
Iclusig is used to treat adults with the following leukaemia types who are no longer benefiting from treatment with other medicines, or have a certain genetic difference known as a T315I mutation:
chronic myeloid leukaemia (CML): a blood cancer involving too many abnormal white blood
cells in the blood and the bone marrow (where blood cells are formed).
Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): a type of leukaemia involving too many immature white blood cells in the blood and blood forming bone
marrow. In this kind of leukaemia, some of the DNA (genetic material) has become rearranged
to form an abnormal chromosome, the Philadelphia chromosome.
Iclusig belongs to a group of medicines called tyrosine kinase inhibitors. In patients with CML and Ph+ ALL, changes in the DNA trigger a signal that tells the body to produce abnormal white blood cells. Iclusig blocks this signal, thereby stopping the production of these cells.
if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before taking Iclusig if you have:
a liver or pancreas disorder or reduced kidney function. Your doctor may want to take additional precautions.
a history of alcohol abuse
had a prior heart attack or stroke
a history of blood clots in your blood vessels
a history of renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
heart problems, including heart failure, irregular heartbeats, and QT prolongation
high blood pressure
or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
a history of bleeding issues
ever had or might now have a hepatitis B infection. This is because Iclusig could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked
by their doctor for signs of this infection before treatment is started.
Your doctor will perform:
evaluations of your heart function and the condition of your arteries and veins
a complete blood count
This will be repeated every 2 weeks for the first 3 months after starting the therapy. Afterwards it is performed monthly or as indicated by the doctor.
checks of the serum protein known as lipase
A serum protein called lipase will be checked every 2 weeks for the first 2 months, then periodically. A break in treatment or a decrease in dose may be required when lipase is
increased.
liver tests
Liver function tests will be performed periodically, as indicated by your doctor.
A brain condition called posterior reversible encephalopathy syndrome (PRES) has been reported in patients treated with ponatinib. Symptoms may include sudden onset of severe headache, confusion, seizures, and vision changes. Tell your doctor straight away if you experience any of these symptoms during your treatment with ponatinib, because it could be serious.
Do not give this medicine to children under 18 years because no data are available in children.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines can affect or be affected by Iclusig:
Avoid grapefruit products such as grapefruit juice.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
receiving treatment with Iclusig are advised not to father a child during treatment. Effective contraception must be used during treatment.
potential risks exist for the unborn child.
Stop breast-feeding during treatment with Iclusig. It is not known if Iclusig passes into breast milk.
You should take special care when driving and using machines as patients taking Iclusig may experience visual disturbance, dizziness, sleepiness, and tiredness.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Iclusig therapy should be prescribed by a doctor experienced in leukaemia treatment. Iclusig is available as:
a 45 mg film-coated tablet for the recommended dose.
a 15 mg film-coated tablet and a 30 mg film-coated tablet to allow for dose adjustments.
an appropriate response to the treatment is reached
the number of white blood cells called neutrophils is reduced.
the number of blood platelets is reduced.
a severe side effect occurs, not affecting the blood
pancreas inflammation.
increased levels of the serum proteins lipase or amylase.
you develop heart or blood vessel problems.
you have a liver disorder.
Iclusig use may be resumed at the same, or a reduced dose, after the event is resolved or controlled. Your doctor may evaluate your response to the treatment at regular intervals.
Swallow the tablets whole, with a glass of water. The tablets can be taken with or without food. Do not crush or dissolve the tablets.
Do not swallow the desiccant canister contained in the bottle.
Make sure you take Iclusig daily for as long as it is prescribed. This is a long-term treatment.
Do not take a double dose to make up for a forgotten dose. Take your next dose at your regular time.
Do not stop taking Iclusig without your doctor’s permission.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Patients aged 65 and over are more likely to be affected by side effects.
lung infection (may cause breathing difficulty)
pancreas inflammation. Inform your doctor immediately if pancreas inflammation occurs.
Symptoms are severe pain in the stomach and back.
fever, often with other signs of infection due to decreased number of white blood cells
heart attack (symptoms include: sudden feeling of increased heart rate, chest pain, breathlessness)
changes in blood levels:
decreased number of red blood cells (symptoms include: weakness, dizziness, fatigue)
decreased number of blood platelets (symptoms include: increased tendency to bleed or bruise)
decreased number of white blood cells called neutrophilis (symptoms include: increase
tendency of infection)
increased level of the serum protein known as lipase
a heart rhythm disorder, abnormal pulse
heart failure (symptoms include: weakness, fatigue, swollen legs)
uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris) and chest pain not in connection with the heart
high blood pressure
narrowing of the arteries in the brain
problems of the blood vessels in the heart muscle
blood infection
swollen, or red area of skin that feels hot and tender (cellulitis)
dehydration
breathing difficulties
fluid in the thorax (may cause breathing difficulty)
diarrhoea
blood clot in a deep vein, sudden vein obstruction, blood clot in a blood vessel of the lung (symptoms include: hot flush, flushing, redness of the face, breathing difficulty)
stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal
sensations)
blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs)
blood clot in the main arteries carrying blood to the head or neck (carotid artery)
constipation
sodium decrease in the blood
increased tendency to bleed or bruise
upper airway infection (may cause breathing difficulty)
decreased appetite
insomnia
headache, dizziness
cough
diarrhoea, vomiting, nausea
increased blood levels of several liver enzymes called:
alanine aminotransferase
aspartate aminotransferase
rash, dry skin, itching
pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms
fatigue, accumulation of fluid in arms and/or legs, fever, pain
inflammation of hair follicles, swollen, red area of skin or underneath skin that feels hot and tender
decreased activity of thyroid gland
fluid retention
low calcium, phosphate or potassium levels in the blood
increased blood sugar or uric acid levels in the blood, high blood fat values of triglycerides
weight loss
mini stroke
nerve disorder in the arms and/or legs (often causes numbness and pain in the hands and feet)
lethargy, migraine
increased or reduced sense of touch or sensation, abnormal sensation such as prickling, tingling and itchiness
blurred vision, dry eye, infection in the eye, visual disturbance
tissue swelling in eyelid or around the eyes, caused by excess fluid
palpitation
pain in one or both legs when walking or exercising, which disappears after some minutes of rest
hot flush, flushing
nosebleed, difficulty producing voice sounds, hypertension in the lungs
increased blood levels of liver and pancreatic enzymes:
amylase
alkaline phosphatase
gamma-glutamyltransferase
heartburn caused by reflux of stomach juices, inflammation in the mouth, abdominal swelling or discomfort or indigestion, dry mouth
stomach bleeding (symptoms include: stomach pain, vomiting blood)
increased blood level of bilirubin - the yellow breakdown substance of the blood pigment (symptoms include: dark amber urine)
pain in skeletal system or neck
skin rash, peeling of the skin, abnormal thickening of the skin, redness, bruising, skin pain, changes in skin colour, hair loss
tissue swelling in face caused by excess fluid
night sweats, increased sweating
inability to develop or maintain an erection
chills, flu-like illness
metabolic disorders caused by the break-down products of dying cancer cells
bleeding in the brain
obstruction of the blood vessels in the eye
heart problems, left sided chest pain, dysfunction of the left heart chamber
narrowing of the blood vessels, poor blood circulation, sudden increase in blood pressure
renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
circulatory problems in the spleen
liver damage, jaundice (symptoms include: yellowing of the skin and eyes)
headache, confusion, seizures, and loss of vision, which may be symptoms of a brain condition known as posterior reversible encephalopathy syndrome (PRES).
painful red lumps, skin pain, skin reddening (inflammation of fatty tissue under the skin).
recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
troubling skin rashes involving blisters or peeling and spread across the body, and involving
tiredness. Inform your doctor immediately if you experience these symptoms.
an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
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 bottle label and carton after EXP. The expiry date refers to the last day of that month.
Store in the original container in order to protect from light.
The bottle contains one sealed plastic canister containing a molecular sieve desiccant. Keep the canister in the bottle. Do not swallow the desiccant canister.
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.
The active substance is ponatinib.
Each 15 mg film-coated tablet contains 15 mg ponatinib (as ponatinib hydrochloride). Each 30 mg film-coated tablet contains 30 mg ponatinib (as ponatinib hydrochloride). Each 45 mg film-coated tablet contains 45 mg ponatinib (as ponatinib hydrochloride).
The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 4000, polyvinyl
alcohol, titanium dioxide (E171). See section 2 “Iclusig contains lactose”.
Iclusig film-coated tablets are white, round and rounded on the upper and lower side.
Iclusig 15 mg film-coated tablets are approximately 6 mm in diameter with "A5" on one side. Iclusig 30 mg film-coated tablets are approximately 8 mm in diameter with "C7" on one side. Iclusig 45 mg film-coated tablets are approximately 9 mm in diameter with "AP4" on one side.
Iclusig is available in plastic bottles, each containing one canister of a molecular sieve desiccant. Bottles are packed within a cardboard box.
Bottles of Iclusig 15 mg contain either 30, 60 or 180 film-coated tablets. Bottles of Iclusig 30 mg contain 30 film-coated tablets.
Bottles of Iclusig 45 mg contain either 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.
Incyte Biosciences Distribution B.V. Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Haupt Pharma Amareg GmbH Donaustaufer Str. 378
93055 Regensburg Germany
Incyte Biosciences Distribution B.V. Paasheuvelweg 25
1105 BP Amsterdam Netherlands
Tjoapack Netherlands B.V. Nieuwe Donk 9
4879 AC Etten-Leur Netherlands
There are also links to other websites about rare diseases and treatments.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.