Product Information for the Patient

Scemblix 20 mg Film-Coated Tablets

Scemblix 40 mg Film-Coated Tablets

asciminib

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

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

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

What is Scemblix

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

What is Scemblix used for

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

How does Scemblix work

With CML Ph+, the body produces many abnormal white blood cells. Scemblix blocks the action of a protein (BCR::ABL1) that produces these abnormal white blood cells, thus 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.

Do not take Scemblix

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

Warnings and precautions

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

• if you have or have had any time pain in the stomach that may be due to problems with your 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 if you have any signs of infection.

Inform your doctor or pharmacist if during treatment with Scemblix:

• you experience weakness, bleeding, or spontaneous bruising and frequent infections with symptoms 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 heart electrical activity called QT interval prolongation that 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 medications that may have an undesirable effect on heart function (torsades de pointes) (see “Other medications and Scemblix”).
• you experience headaches, 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 check that the treatment is having the desired effect. You will have periodic tests during treatment, including blood tests. These tests control:

• the number of cells in your blood (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 medication to children or adolescents under 18 years old.

Other medications and Scemblix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. In particular, inform your doctor or pharmacist if you are using:

• medications that are normally used to treat seizures (attacks), such as carbamazepine, phenobarbital, or phenytoin.
• medications for pain and/or sedatives that are used before or after medical or surgical procedures, such as alfentanil or fentanyl.
• medications used to treat migraines or dementia, such as dihydroergotamine or ergotamine.
• medications that may have an undesirable effect on heart electrical activity (torsades de pointes), such as bepridil, chloroquine, clarithromycin, halofantrine, haloperidol, methadone, moxifloxacin, or pimozide.
• medications used to reduce blood clotting, such as warfarin or dabigatran.
• medications used to treat severe intestinal inflammation or severe joint inflammation or rheumatoid arthritis, such as sulfasalazine or colchicine.
• medications used to treat cancer, severe joint inflammation, or psoriasis, such as methotrexate.
• medications used to reduce cholesterol levels in the blood, such as pravastatin, atorvastatin, pitavastatin, rosuvastatin, and simvastatin.
• medications used to treat high blood pressure and other heart conditions, such as digoxin.
• St. John's Wort (also known as Hypericum perforatum), a medicinal plant used to treat depression.

If you are already taking Scemblix, inform your doctor of any new medication that is prescribed to you.

If you are unsure whether your medication is one of the medications mentioned above, ask your doctor or pharmacist.

Scemblix with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

Scemblix may be bad for your baby. If you are a woman of childbearing age, 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 do 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 can become pregnant, you must use an effective contraceptive method to avoid becoming pregnant during treatment with Scemblix and at least 3 days after stopping it. Ask your doctor about the most effective contraceptive methods.

Breastfeeding

We do not know if Scemblix passes into breast milk. Therefore, you should stop breastfeeding while taking it and at least 3 days after stopping it.

Driving and using machines

The influence of this medication on your ability to drive and use machines is negligible or insignificant. If after taking this medication you experience adverse effects (such as dizziness or visual disturbances) that may affect your ability to drive or use tools or machines safely, you should avoid these activities until the effect has disappeared.

Scemblix contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated 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 per 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 temporarily or permanently stop treatment.

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 medication 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 the tablets, or crush or chew them to ensure the correct dosage.

How long to take Scemblix

Continue taking this medication for the time your doctor tells you. 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 medication, 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 has taken it accidentally, inform your doctor, or go to the doctor immediately. Show them the packaging. You may need medical attention.

If you forget to take Scemblix

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

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

If you interrupt Scemblix treatment

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious

If you experience a serious side effect, stop taking the medicine and inform your doctor immediately.

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

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

Common(may affect 1 in 10 patients)

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

Uncommon(may affect up to 1 in 100 patients)

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

Other side effects

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

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

• upper respiratory tract infections (infections of the throat and nose)
• fatigue, paleness, weakness (signs of low red blood cell count, anemia)
• headache, dizziness, chest pain, shortness of breath (signs of high blood pressure, hypertension)
• headache
• dizziness
• shortness of breath, difficulty breathing (signs of dyspnea)
• cough
• vomiting
• diarrhea
• nausea
• abdominal pain (abdominal cramps)
• skin rash
• itching (pruritus)
• muscle pain, bone pain, joint pain (musculoskeletal pain)
• joint pain (arthralgia)
• fatigue (fatigue)
• generalized swelling (edema)
• fever (pyrexia)

Common(may affect up to 1 in 10 patients)

• fever, cough, shortness of breath, wheezing (signs of lower respiratory tract infection)
• influenza
• loss of appetite
• blurred vision
• dry eyes
• palpitations
• chest pain, cough, hiccups, rapid breathing, accumulation of fluid between the lungs and the chest cavity, which, if severe, may cause shortness of breath (pleural effusion)
• chest pain (non-cardiac chest pain)
• severe pain in the mouth of the stomach (sign of pancreatitis)
• skin rash with itching (urticaria)

Uncommon(may affect up to 1 in 100 patients)

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

Abnormal blood test results

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

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

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

Common(may affect up to 1 in 10 patients)

• elevated levels of bilirubin (liver function)
• elevated levels of creatine phosphokinase enzyme (muscle function)
• elevated levels of sugar

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after EXP. The expiration date is the last day of the month indicated.

Do not store above 25 °C.

Store in the original packaging to protect it from moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Scemblix Composition

• The active ingredient is asciminib.

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

Each film-coated tablet of 40 mg 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), hydroxypropyl cellulose (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.

Appearance of the product and contents of the pack

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

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

Scemblix is presented in a blister pack containing 10 film-coated tablets.

It is available in the following pack sizes:

Packs 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 some pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Farmacéutica, S.A.

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 more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

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