SCEMBLIX 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Scemblix®20mg film-coated tablets

Scemblix®40mg film-coated tablets

asciminib

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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.

Contents of the pack

1. What is Scemblix and what is it used for
2. What you need to know before you take Scemblix
3. How to take Scemblix
4. Possible side effects
5. Storage of Scemblix
6. Contents of the pack and other information

1. What is Scemblix and what is it used for

What is Scemblix

Scemblix contains the active substance asciminib, which belongs to a group of medicines called kinase inhibitors.

What Scemblix is used for

Scemblix is a medicine for cancer, used to treat adults with a type of blood cancer (leukaemia) called chronic myeloid leukaemia in the chronic phase with positive Philadelphia chromosome (CML-CP Ph+). It is given to patients who have already been treated with two or more medicines for this type of leukaemia called tyrosine kinase inhibitors.

How Scemblix works

In CML-CP Ph+, the body produces many abnormal white blood cells. Scemblix blocks the action of a protein (BCR::ABL1) produced by these abnormal white blood cells, stopping their uncontrolled division and growth.

If you have any questions about how this medicine works or why you have been prescribed it, ask your doctor or pharmacist.

2. What you need to know before you take Scemblix

Do not take Scemblix

• if you are allergic to asciminib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before starting Scemblix if any of the following apply to you:

• if you have or have had stomach pain that may be due to pancreas problems (inflamed pancreas, pancreatitis).
• if you have or may have had hepatitis B. This is because Scemblix may reactivate hepatitis B. Before starting treatment, your doctor will check if you have signs of infection.

Tell your doctor or pharmacist if, during treatment with Scemblix:

• you experience weakness, bleeding or bruising, and frequent infections with signs such as fever, chills, sore throat or mouth ulcers. These may be signs of reduced bone marrow activity, resulting in myelosuppression (a decrease in the number of white blood cells, red blood cells and platelets).
• blood tests show you have high levels of the enzymes lipase and amylase (signs of pancreas damage, also known as pancreatitis).
• you have a heart disorder or a heart rhythm disorder, such as an irregular heartbeat or abnormal heart electrical activity called QT interval prolongation seen on an electrocardiogram (ECG).
• blood tests show you have low levels of potassium or magnesium (hypokalaemia or hypomagnesaemia).
• you are being treated with medicines that may have an unwanted effect on heart function (Torsades de pointes) (see “Other medicines and Scemblix”).
• you experience headache, dizziness, chest pain or difficulty breathing (possible signs of high blood pressure, also known as hypertension).

Monitoring during your treatment with Scemblix

Your doctor will regularly check your condition to ensure the treatment is having the desired effect. You will have regular tests during treatment, including blood tests. These tests will check:

• the number of cells in your blood (white blood cells, red blood cells and platelets).
• the levels of pancreatic enzymes (amylase and lipase).
• the levels of electrolytes (potassium, magnesium).
• your heart rate and blood pressure.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Scemblix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are using:

• medicines normally used to treat seizures (fits), such as carbamazepine, phenobarbital or phenytoin.
• medicines for pain and/or sedatives used before or after medical or surgical procedures, such as alfentanil or fentanyl.
• medicines used to treat migraines or dementia, such as dihydroergotamine or ergotamine.
• medicines that may have an unwanted effect on heart function (Torsades de pointes), such as bepridil, chloroquine, clarithromycin, halofantrine, haloperidol, methadone, moxifloxacin or pimozide.
• medicines used to reduce blood clotting, such as warfarin or dabigatran.
• medicines used to treat severe intestinal inflammation or painful and rheumatic joint inflammation, such as sulfasalazine or colchicine.
• medicines used to treat cancer, severe rheumatic joint inflammation or psoriasis, such as methotrexate.
• rosuvastatin, a medicine used to lower blood cholesterol levels.
• medicines used to treat high blood pressure and other heart diseases, such as digoxin.
• St. John's Wort (also known as Hypericum perforatum), a herbal medicine used for depression.

If you are already taking Scemblix, tell your doctor about any new medicine that is prescribed for you.

If you are not sure if your medicine is one of the medicines mentioned above, ask your doctor or pharmacist.

Scemblix with food and drink

Do not take this medicine with food. You should take it at least 2 hours after and 1 hour before any food. For more information, see “When to take Scemblix” in section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Scemblix may harm your baby. If you are a woman who can become pregnant, your doctor will explain the possible risks of taking it during pregnancy and breastfeeding.

If you are a woman who can become pregnant, your doctor may perform a pregnancy test before starting treatment with Scemblix if necessary.

If you become pregnant or think you may be pregnant after starting treatment with Scemblix, tell your doctor immediately.

Contraceptive advice for women

If you are a woman who can become pregnant, you must use an effective contraceptive method to avoid becoming pregnant during treatment with Scemblix and for at least 3 days after stopping treatment. Ask your doctor about the most effective contraceptive methods.

Breastfeeding

It is not known if Scemblix passes into breast milk. Therefore, you must stop breastfeeding while taking Scemblix and for at least 3 days after stopping treatment.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. If, after taking this medicine, you experience side effects such as dizziness or visual disturbances that could affect your ability to drive or use tools or machines safely, you should not drive or use machines until the effect has stopped.

Scemblix contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Scemblix

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much Scemblix to take

Your doctor will tell you exactly how many tablets to take each day and how to take them.

The recommended dose is 1 Scemblix 40 mg tablet twice a day. Take 1 tablet, and the other approximately 12 hours later.

Depending on how you respond to treatment and any possible side effects, your doctor may reduce your dose or interrupt treatment temporarily or permanently.

When to take Scemblix

Take Scemblix:

• at least 2 hours after any food
• then wait at least 1 hour before eating again

If you take this medicine at the same time every day, it will help you remember to take it.

How to take Scemblix

Swallow the tablets whole with a glass of water. Do not break, crush or chew the tablets to ensure the correct dose.

How long to take Scemblix

Continue taking this medicine for as long as your doctor tells you. This is a long-term treatment, possibly for several months or years. Your doctor will regularly check your condition to ensure the treatment is having the desired effect.

If you have any questions about how long to take this medicine, talk to your doctor or pharmacist.

If you take more Scemblix than you should

If you have taken more tablets than you should, or if someone else has taken your medicine by mistake, tell your doctor or go to your doctor immediately. Show them the pack. You may need medical attention.

If you forget to take Scemblix

If it is less than 6 hours until your next dose, skip the missed dose and take the next dose at the usual time.

If it is more than 6 hours until your next dose, take the missed dose and then take the next dose at the usual time.

If you stop taking Scemblix

Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious

If you experience any serious side effects, stop taking the medicine and tell your doctor immediately.

Very common(may affect more than 1 in 10 people)

• spontaneous bleeding or bruising (signs of low platelet levels, thrombocytopenia)
• fever, sore throat, frequent infections (signs of low white blood cell levels, neutropenia)

Common(may affect up to 1 in 10 people)

• irregular heartbeat, change in heart electrical activity (QT interval prolongation)

Uncommon(may affect up to 1 in 100 people)

• fever above 38°C associated with low white blood cell levels (febrile neutropenia)
• low levels of all types of blood cells (pancytopenia)

Other side effects

Other side effects are those listed below. If these side effects get worse, then tell your doctor or pharmacist.

Very common(may affect more than 1 in 10 people)

• throat and nose infections (upper respiratory tract infection)
• fatigue, tiredness, paleness (signs of low red blood cell levels, anaemia)
• headache, dizziness, chest pain, difficulty breathing (signs of high blood pressure, hypertension)
• headache
• dizziness
• shortness of breath, difficulty breathing (signs of dyspnoea)
• cough
• vomiting
• diarrhoea
• nausea
• abdominal pain (stomach)
• rash
• itching (pruritus)
• muscle pain, bone pain and joint pain (musculoskeletal pain)
• joint pain (arthralgia)
• fatigue (tiredness)
• general swelling (oedema)
• fever (pyrexia)

Common(may affect up to 1 in 10 people)

• fever, cough, difficulty breathing, wheezing (signs of lower respiratory tract infection)
• flu
• loss of appetite
• blurred vision
• dry eyes
• palpitations
• chest pain, cough, hiccups, rapid breathing, fluid accumulation between the lungs and the chest cavity that, if severe, could leave you breathless (pleural effusion)
• chest pain (non-cardiac chest pain)
• severe stomach pain (sign of pancreatitis)
• itchy rash (urticaria)

Uncommon(may affect up to 1 in 100 people)

• allergic reactions that may include skin rash, hives, difficulty breathing, or low blood pressure (hypersensitivity)

Abnormal blood test results

During treatment, your blood test results may be affected, giving your doctor information about the functioning of your organs. For example:

Very common(may affect more than 1 in 10 people)

• high levels of the enzymes lipase and amylase (pancreas function)
• high levels of the enzymes transaminases, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyltransferase (GGT) (liver function)
• high levels of fats/lipids

Common(may affect up to 1 in 10 people)

• high levels of the substance bilirubin (liver function)
• high levels of the enzyme creatine phosphokinase (muscle function)
• high levels of sugar

Reporting of side effects

If you experience 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.

5. Storage of Scemblix

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 carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Store in the original package to protect from moisture.

Do not use this medicine if you notice the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Scemblix Composition

• The active ingredient is asciminib.

Each 20 mg film-coated tablet contains asciminib hydrochloride, equivalent to 20 mg of asciminib.

Each 40 mg film-coated tablet contains asciminib hydrochloride, equivalent to 40 mg of asciminib.

• The other ingredients are:

20 mg and 40 mg film-coated tablets: lactose monohydrate, microcrystalline cellulose (E460i), hydroxypropylcellulose (E463), sodium croscarmellose (E468), polyvinyl alcohol (E1203), titanium dioxide (E171), magnesium stearate, talc (E553b), colloidal silicon dioxide, lecithin (E322), xanthan gum (E415), red iron oxide (E172).

Only 20 mg film-coated tablets: yellow iron oxide (E172). Only 40 mg film-coated tablets: black iron oxide (E172).

See "Scemblix contains lactose and sodium" in section 2.

Product Appearance and Package Contents

Scemblix 20 mg film-coated tablets (tablets): biconvex, round pale yellow tablets with beveled edges, approximately 6 mm in diameter, engraved with the company logo on one side and "20" on the other.

Scemblix 40 mg film-coated tablets (tablets): biconvex, round white-purple tablets with beveled edges, approximately 8 mm in diameter, engraved with the company logo on one side and "40" on the other.

Scemblix is available in blisters containing 10 film-coated tablets.

It is available in the following formats:

Packages containing 20 or 60 film-coated tablets.

Scemblix 40 mg film-coated tablets are also available in a multi-pack containing 180 (3 packs of 60) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus: 04/2025

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu