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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I taking Scemblix?
Scemblix contains the active ingredient asciminib. Scemblix is used to treat patients
18 years and over with Philadelphia chromosome-positive chronic myeloid leukaemia
(Ph+ CML) in chronic phase (CP) and patients with Ph+ CML in CP who have a certain
genetic difference (mutation) called T315I.
2. What should I know before I take Scemblix?
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 Scemblix and affect how it works.
4. How do I take Scemblix?
The usual total daily dose of Scemblix is 80 mg (2 tablets of Scemblix 40 mg, per
day). Do not take Scemblix with food.
5. What should I know while taking Scemblix?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Scemblix.
Have regular tests to monitor your condition
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Things you should not do
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Do not stop using this medicine suddenly.
Do not take Scemblix with food
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Scemblix
affects you.
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Drinking alcohol
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There are no known interactions between Scemblix and alcohol.
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Looking after your medicine
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Store below 25°C; protect from moisture
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6. Are there any side effects?
Common side effects include sudden bleeding or bruising; fever, sore throat, frequent
infections; nose and throat infections; tiredness, pale skin; headache, dizziness,
chest pain or difficulty breathing; cough; vomiting; diarrhoea; feeling sick; stomach
pain; rash; pain in muscles, bones or joints; joint pain; itching.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
asciminib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Scemblix. 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 Scemblix.
Where to find information in this leaflet:
1. Why am I taking Scemblix?
Scemblix contains the active ingredient asciminib. Scemblix treats a type of blood cancer (leukaemia) in which the body produces too
many abnormal white blood cells. Chronic phase (CP) is the first phase of this blood
cancer.
Scemblix is used to treat patients 18 years and over with Philadelphia chromosome-positive chronic myeloid
leukaemia (Ph+ CML) in CP who
- were previously treated with medicines of a similar type called tyrosine kinase
inhibitors.
- have a certain genetic difference (mutation) called T315I.
Scemblix blocks the action of a protein (BCR-ABL1) of the abnormal white blood cells
and stops them expanding and growing.
2. What should I know before take Scemblix?
Warnings
Do not take Scemblix if:
you are allergic to asciminib, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
have or have ever had severe upper stomach pain (inflamed pancreas, pancreatitis).
have or have ever had a hepatitis B infection. This is because during treatment with
Scemblix, hepatitis B may become active again. Patients will be carefully checked
by their doctor for signs of this infection before starting treatment.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss with you the potential risks of taking Scemblix during pregnancy
or breast-feeding.
It is not known if Scemblix passes into your breast-milk. Breast-feeding is not recommended
during treatment with Scemblix and for at least 3 days after the last dose.
Females of child-bearing potential
Scemblix can harm your unborn baby. If you are a woman of child-bearing age, your
doctor, pharmacist or healthcare provider will check if you are pregnant and perform
a pregnancy test if necessary before starting treatment with Scemblix.
If you may become pregnant, you should use an effective birth control during treatment
with Scemblix and for at least 3 days after the last dose. Ask your doctor about effective
birth control options.
Children and adolescents
Scemblix is not to be used in children or adolescents under 18 years of age. It is
not known whether Scemblix is safe and effective in children or 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 Scemblix and affect how it works:
Medicines used to treat bacterial infections such as clarithromycin, telithromycin
or troleandomycin.
Medicines used to treat fungal infections such as itraconazole, ketoconazole or voriconazole.
Medicines used to treat human immunodeficiency virus (HIV) such as ritonavir, indinavir,
nelfinavir or saquinavir.
An antibiotic used to treat infections caused by bacteria (rifampicin).
Medicines used to treat seizures such as carbamazepine, phenobarbital or phenytoin.
St. John’s wort (also known as Hypericum perforatum), a herbal medicine used to treat
depression and other conditions.
Food also interferes with Scemblix and affects how it works. Therefore do not take
Scemblix with food.
Scemblix may interfere with some medicines and affect how they work:
Medicines used to treat pain or used as sedatives before or during medical or surgical
procedures, such as alfentanil, fentanyl or midazolam.
Medicines used to treat migraine or dementia, such as dihydroergotamine or ergotamine.
Medicines used to reduce the blood’s ability to clot, such as warfarin.
Medicines used to treat severe inflammation of the bowel or severe rheumatic joint
inflammation, such as sulfasalazine.
Medicines used to treat cancer, severe rheumatic joint inflammation, or psoriasis,
such as methotrexate
Medicines used to reduce blood cholesterol levels, such as pravastatin, atorvastatin,
rosuvastatin and simvastatin
Caution should be used when taking Scemblix with medicines that may have an unwanted
effect on the electrical activities of the heart (torsades de pointes), such as bepridil,
chloroquine, clarithyromycin, halofantrine, haloperidol, methadone, moxifloxacin or
pimozide.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Scemblix.
4. How do I take Scemblix?
How much to take
Take Scemblix exactly as your doctor tells you
Do not change your dose or how frequently you take Scemblix or stop taking Scemblix
unless your doctor tells you to.
When to take Scemblix
If instructed to take daily dose once a day take dose at the same time each day.
If instructed to take dose twice a day, take each dose at the same times each day,
approximately 12 hours apart.
How to take Scemblix
Take Scemblix without food. You should avoid eating for at least 2 hours before and
1 hour after taking Scemblix.
Swallow tablets whole. Do not break, crush or chew Scemblix tablets.
If you forget to use Scemblix
Scemblix should be used regularly at approximately the same time each day.
If you take Scemblix once daily:
If you miss your dose at the usual time by more than 12 hours, skip the missed dose
and take the next one as usual.
If you take Scemblix twice daily:
If you miss your dose at the usual time by more than 6 hours, skip the missed dose
and take the next one as usual.
If you take too much Scemblix
If you think that you have taken too much Scemblix, 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 taking Scemblix?
Things you should do
Keep all doctor's appointments, as your doctor needs to regularly monitor your condition.
Call your doctor straight away if you:
experience rash, itching, hives, difficulty breathing, wheezing or coughing, light-headedness,
dizziness, skin reddening, face/throat swelling, blue discoloration of the lips, tongue
or skin (signs of allergic reaction).
Remind any doctor, dentist or pharmacist you visit that you are using Scemblix.
Things you should not do
Do not stop taking this medicine suddenly.
Monitoring during your treatment
You will have regular tests including blood tests during treatment. These tests will
monitor:
The amount of blood cells (white blood cells, red blood cells and platelets).
The levels of pancreas enzymes (amylase and lipase).
The levels of electrolytes (potassium, magnesium).
Your heart rate (this could include an electrocardiogram/ECG) and your blood pressure.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Scemblix
affects you.
If you experience dizziness or changes to your vision (such as blurred vision), you
should not take part in these activities.
Drinking alcohol
Tell your doctor if you drink alcohol.
There are no known interactions between Scemblix and alcohol.
Looking after your medicine
Store below 25°C
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 take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take 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
Serious side effects
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Serious side effects
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What to do
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Signs of an allergic reaction including trouble breathing or swallowing; swelling
of the face, lips or tongue; skin rash or flushing of your skin; feeling dizzy or
faint; fever; fast heartbeat
Fever, coughing, difficulty breathing, wheezing (signs of lower respiratory tract
infections)
Chest pain or difficulty breathing/shortness of breath, irregular heartbeat, swelling
in the ankles or feet, dizziness, weight gain, numbness or weakness on one side of
your body, decreased vision/loss of vision, trouble talking, pain in your arms, legs,
back, neck or jaw, headache, severe stomach area pain. This could be related to heart
problems.
Sudden bleeding or bruising, blood in your urine or stool, fever, or any signs of
infection. This could be related to low blood counts.
Fever, sore throat, frequent infections
Influenza
Fever above 38°C
Severe upper stomach pain
Sudden stomach-area pain or discomfort, nausea or vomiting. This could be related
to pancreas problems.
Symptoms of elevated blood pressure including confusion, headaches, dizziness, chest
pain or shortness of breath.
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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 Scemblix contains
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Active ingredient
(main ingredient)
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asciminib
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Other ingredients
(inactive ingredients)
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Lactose monohydrate, microcrystalline cellulose, hyprolose, croscarmellose sodium,
polyvinyl alcohol, titanium dioxide, magnesium stearate, purified talc, silicon dioxide,
iron oxide (20 mg: yellow and red; 40 mg: black and red), lecithin, xanthan gum
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Potential allergens
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Sugars as lactose and soybean products
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Do not take this medicine if you are allergic to any of these ingredients.
What Scemblix looks like
Scemblix is supplied as:
Scemblix 20 mg film coated tablets: The tablets are pale yellow, round, biconvex,
film-coated tablets with beveled edges, approximately 6.2 mm diameter, unscored, debossed
with “Novartis” logo on one side and “20” on the other side. in Scemblix 20 mg film
coated tablets in blister packs containing 20 or 60 tablets (Aust R 371019).
Scemblix 20 mg film coated tablets in bottles containing 20 or 60 tablets (AUST R
407914).*
Scemblix 40 mg film coated tablets: The tablets are violet white, round, biconvex,
film-coated tablets with beveled edges, approximately 8.2 mm diameter, unscored, debossed
with “Novartis” logo on one side and “40” on the other side. in Scemblix 40 mg film
coated tablets in blister packs containing blister packs containing 20 or 60 tablets
(Aust R 371018).
Scemblix 40 mg film coated tablets in bottles containing 20, 60 or 300 tablets (AUST
R 407913).*
*Not all products may be marketed
Who distributes Scemblix
Scemblix 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
This leaflet was prepared in September 2024.
(sce170924c based on PI sce170924i)