Scemblix 20 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Scemblix® 20 mg film-coated tablets

Scemblix® 40 mg film-coated tablets

asciminib

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet contains information on how to report side effects.

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Scemblix is and what it is used for

What Scemblix is

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

What Scemblix is used for

Scemblix is a cancer medicine used to treat adults with a type of blood cancer (leukaemia) called Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic phase (Ph+ CML-CP).

How Scemblix works

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

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

2. What you need to know before taking Scemblix

Do not take Scemblix

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

Warnings and precautions

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

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

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

• you experience weakness, bleeding or spontaneous bruising, and frequent infections with signs such as fever, chills, sore throat or mouth ulcers. These may be signs of decreased bone marrow activity, resulting in myelosuppression (a reduction in the number of white blood cells, red blood cells and platelets).
• blood tests show that you have elevated levels of enzymes called lipase and amylase (signs of pancreatic damage, also known as pancreatic toxicity).
• you have a heart condition or a heart rhythm disorder, such as irregular heartbeat or abnormal electrical activity of the heart called QT interval prolongation, which is seen on an electrocardiogram (ECG).
• blood tests show that you have low levels of potassium or magnesium (hypokalemia or hypomagnesemia).
• you are being treated with medicines that may have an undesirable 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 review your condition to ensure the treatment is having the desired effect. You will undergo periodic tests during treatment, including blood tests. These tests monitor:

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

Children and adolescents

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

Other medicines and Scemblix

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

• medicines normally used to treat seizures (fits), such as carbamazepine, phenobarbital or phenytoin
• painkillers 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 undesirable effect on the heart's electrical activity (torsades de pointes), such as bepridil, chloroquine, clarithromycin, halofantrine, haloperidol, methadone, moxifloxacin or pimozide
• medicines used to reduce the blood's ability to clot, such as warfarin or dabigatran
• medicines used to treat severe intestinal inflammation or painful rheumatic 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 conditions, such as digoxin
• St. John’s wort (also known as Hypericum perforatum), a herbal remedy used for depression

If you are already taking Scemblix, you must inform your doctor about any new medicine prescribed to you.

If you are unsure whether your medicine is one of those listed above, ask your doctor or pharmacist.

Scemblix with food and drink

Do not take this medicine with food. You must 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Scemblix may harm your baby. If you are a woman of childbearing age, your doctor will explain the potential risks of taking it during pregnancy and breastfeeding.

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

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

Contraception advice for women

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

Breastfeeding

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

Driving and using machines

The influence of this medicine on the ability to drive and use machines is none or negligible. However, if after taking this medicine you experience adverse effects (such as dizziness or visual disturbances) that could affect your ability to drive or operate tools or machinery safely, you should avoid these activities until the effects have subsided.

Scemblix contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Scemblix

Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much Scemblix to take

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

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

The recommended total daily dose of Scemblix is 80 mg. You may take the daily dose in the following ways:

• Once daily: take 2 tablets at approximately the same time each day, OR
• Twice daily: take 1 tablet and, approximately 12 hours later, take the second tablet.

When to take Scemblix

Take Scemblix:

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

Taking this medicine at the same time each day 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 correct dosing.

How long to take Scemblix

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

If you have any questions about how long you should take this medicine, speak with your doctor or pharmacist.

If you take more Scemblix than you should

If you have taken more tablets than you should, or if someone has accidentally taken this medicine, inform your doctor or go immediately to the hospital. Show the package to the doctor. You may require medical attention.

If you forget to take Scemblix

If you take Scemblix once daily:

If less than 12 hours remain until your next dose, skip the missed dose and take the next dose at the usual time.

If more than 12 hours remain until your next dose, take the missed dose and then continue with your regular schedule.

If you take Scemblix twice daily:

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

If more than 6 hours remain 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 has instructed you to do so.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Some adverse effects may be serious

If you experience any serious adverse effect, stop taking this medicine and contact your doctor immediately.

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

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

Uncommon (may affect up to 1 in 100 patients)

• fever above 38°C associated with low white blood cell levels (febrile neutropenia)
• low levels of all types of blood cells (pancytopenia)
• irregular heartbeat, changes in the heart's electrical activity (QT interval prolongation)

Other adverse effects

Other adverse effects are listed below. If these adverse effects worsen, inform your doctor or pharmacist.

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

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

Common (may affect up to 1 in 10 patients)

• fever, cough, difficulty breathing, wheezing (signs of lower respiratory tract infection)
• influenza (flu)
• tiredness, weight gain, skin and hair changes (signs of reduced thyroid gland function, hypothyroidism)
• loss of appetite
• blurred vision
• dry eyes
• palpitations
• shortness of breath, difficulty breathing (signs of dyspnoea)
• chest pain, cough, hiccups, rapid breathing, fluid accumulation between the lungs and the chest cavity which, if severe, could leave you breathless (pleural effusion)
• chest pain (non-cardiac chest pain)
• severe upper abdominal pain (signs of inflamed pancreas, pancreatitis)
• itchy rash (urticaria)
• generalized swelling (oedema)
• fever (pyrexia)

Uncommon (may affect up to 1 in 100 patients)

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

Abnormalities in blood tests

During treatment, blood test results may be altered, providing your doctor with information about how your organs are functioning. For example:

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

• increased levels of fats/lipids (dyslipidaemia)
• increased levels of lipase and amylase enzymes (pancreatic function)
• increased levels of transaminase enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) (liver function)

Common (may affect up to 1 in 10 patients)

• increased levels of bilirubin (liver function)
• increased levels of creatine phosphokinase enzyme (muscle function)
• increased blood sugar levels (hyperglycaemia)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 the month indicated.

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Pack contents and other information

Composition of Scemblix

• The active substance 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 components 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), iron oxide red (E172).

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

See “Scemblix contains lactose and sodium” in section 2.

Nature and contents of the container

Scemblix 20 mg film-coated tablets (tablets): biconvex, round, pale yellow tablets with bevelled edges, approximately 6 mm in diameter, printed 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 bevelled edges, approximately 8 mm in diameter, printed with the company logo on one side and “40” on the other.

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

The following pack sizes are available:

Packs containing 20 or 60 film-coated tablets.

Scemblix 40 mg film-coated tablets are also available in a multi-pack containing 180 tablets (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
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

Novartis Pharmaceutical Manufacturing LLC
Verovškova Ulica 57
1000 Ljubljana
Slovenia

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this package leaflet:

Other sources of information

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

ANNEX IV

CONCLUSIONS ON THE APPLICATION FOR MARKETING PROTECTION AND DATA EXCLUSIVITY FOR ONE YEAR SUBMITTED BY THE EUROPEAN MEDICINES AGENCY

Conclusions submitted by the European Medicines Agency on:

• marketing protection for one year

The CHMP has reviewed the data submitted by the marketing authorisation holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication provides a significant clinical benefit compared to existing treatments, as further explained in the European Public Assessment Report.