Scemblix

Patient Information Leaflet

Scemblix 20 mg film-coated tablets, 40 mg film-coated tablets

asciminib
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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
protein kinase inhibitors.

What Scemblix is used for
Scemblix is an anticancer 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 a large number of abnormal white blood cells. Scemblix blocks
the action of a protein (BCR::ABL1) produced by these abnormal white blood cells, thereby stopping their
division and growth.

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

2. What you should 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 taking Scemblix if any of the following apply to you:

• if you have or have ever had severe upper abdominal pain that may be due to problems with your pancreas (inflamed pancreas, pancreatitis).
• if you have ever had or may currently have hepatitis B infection. This is because Scemblix can cause reactivation of hepatitis B. Your doctor will closely monitor you for signs of this infection before starting treatment.

Tell your doctor or pharmacist immediately if, during treatment with Scemblix,
you experience any of the following conditions:

• if you develop weakness, spontaneous bleeding or bruising, and frequent infections with symptoms 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).
• if blood tests show that you have elevated levels of enzymes called lipase and amylase (signs of pancreatic damage, also known as pancreatic toxicity).
• if you have a heart condition or a heart rhythm disorder, such as an irregular heartbeat or abnormal electrical activity of the heart called QT interval prolongation, which can be seen on an electrocardiogram (ECG).
• if blood tests show that you have low levels of potassium or magnesium (hypokalaemia or hypomagnesaemia).
• if you are being treated with medicines that may have an undesirable effect on heart function (torsades de pointes) (see "Other medicines and Scemblix").
• if you develop headache, dizziness, chest pain or shortness of breath (possible signs of high blood pressure, also known as hypertension).

Monitoring during treatment with Scemblix
Your doctor will regularly check your condition to ensure the treatment is having the desired effect. During treatment, you will have regular tests, including blood tests. These tests will 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).
• 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 take any other medicines. In particular, inform your doctor or pharmacist if you are using:

• medicines usually used to treat seizures (fits), such as carbamazepine, phenobarbital or phenytoin.
• medicines used to treat pain and/or as sedatives before or during medical or surgical procedures, such as alfentanil or fentanyl.
• medicines used to treat migraine 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 clotting ability, such as warfarin or dabigatran.
• medicines used to treat severe intestinal inflammation or severe painful 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 reduce cholesterol levels in the blood.
• 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 medicine used to treat depression.

If you are already taking Scemblix, you must inform your doctor if you are prescribed any new medicine.
Ask your doctor or pharmacist if you are unsure whether your medicine is one of those listed above.
Scemblix with food and drink
Do not take this medicine with food. Take it at least 2 hours after and 1 hour before any meal. For further information, see "When to take Scemblix" in section 3.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Scemblix may harm the unborn child. If you are a woman of childbearing potential, your doctor will discuss with you the potential risks of taking this medicine during pregnancy or breastfeeding.
If you become pregnant or think you may be pregnant after starting treatment with Scemblix, inform your doctor immediately.
Contraceptive advice for women
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with Scemblix and for at least 3 days after stopping the medicine to avoid pregnancy. Ask your doctor about effective contraceptive methods.
Breastfeeding
It is not known whether Scemblix passes into breast milk. Therefore, you must stop breastfeeding during treatment with this medicine and for at least 3 days after stopping it.
Driving and using machines
This medicine does not affect or has negligible effect on the ability to drive vehicles and use machines. However, if after taking this medicine you experience side effects (such as dizziness or visual disturbances) that could potentially affect your ability to drive or safely operate tools or machinery, you should refrain from these activities until the effect has resolved.
Scemblix contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Scemblix

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How much Scemblix to take
Your doctor will tell you exactly how many tablets you need to take each day and how to take them.
Depending on your response to treatment and any possible side effects, your doctor may ask you to
switch to a lower dose or to temporarily or permanently stop treatment.
The recommended total daily dose of Scemblix is 80 mg. You may take the daily dose:

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

When to take Scemblix
Take Scemblix:

• at least 2 hours after any food
• then wait at least 1 hour before eating again.
  Taking this medicine at the same time every 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 proper 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 that may last for months or years. Your doctor will regularly monitor your condition to check that the treatment is working as intended.
If you have any questions about how long to take this medicine, speak to your doctor or pharmacist.
If you take more Scemblix than you should
If you have taken more tablets than you were supposed to, or if someone else has accidentally taken your medicine, contact a doctor immediately for advice. Show the packaging. Medical treatment may be necessary.
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 one as scheduled.
If more than 12 hours remain until your next dose, take the missed dose and then take the next one as scheduled.
If you take Scemblix twice daily:
If less than 6 hours remain until your next dose, skip the missed dose and take the next one as scheduled.
If more than 6 hours remain until your next dose, take the missed dose and then take the next one as scheduled.
If you stop taking Scemblix
Do not stop treatment with this medicine unless your doctor tells you to.
If you have any doubts about how to use this medicine, consult 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 can be serious
If you experience any serious side effect, stop taking this medicine and contact 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 count, neutropenia)

Uncommon (may affect up to 1 in 100 people)

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

Other possible side effects
Other side effects include those listed below. If these side effects become severe, inform your doctor or pharmacist.

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

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

Common (may affect up to 1 in 10 people)

• fever, cough, difficulty breathing, wheezing (signs of lower respiratory tract infections)
• influenza
• fatigue, weight gain, changes in skin and hair (signs of underactive thyroid, hypothyroidism)
• loss of appetite
• blurred vision
• dry eyes
• palpitations
• chest pain, cough, hiccups, rapid breathing, fluid accumulation between the lungs and the chest cavity which, if severe, may cause breathlessness (pleural effusion)
• shortness of breath, laboured breathing (signs of dyspnoea)
• chest pain (non-cardiac chest pain)
• severe pain in the upper abdomen (sign of inflammation of the pancreas, pancreatitis)
• itchy rash (urticaria)
• generalised swelling (oedema)
• fever (pyrexia)

Uncommon (may affect up to 1 in 100 people)

• allergic reaction which may include rash, urticaria, difficulty breathing or low blood pressure (hypersensitivity)

Abnormal blood test results
During treatment, blood test results may be abnormal, which can provide your doctor with information about how your organs are functioning. For example:

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

• high levels of fats/lipids (dyslipidaemia)
• high levels of the enzymes lipase and amylase (pancreatic function)
• elevated 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 people)

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

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store 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 blister after EXP and on the carton after Exp. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice any damage to the packaging or signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Scemblix contains

• 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 excipients are: 20 mg and 40 mg film-coated tablets: lactose monohydrate, microcrystalline cellulose (E460i), hydroxypropylcellulose (E463), cross-linked sodium carboxymethylcellulose (E468), polyvinyl alcohol (E1203), titanium dioxide (E171), magnesium stearate, talc (E553b), anhydrous colloidal silica, lecithin (E322), xanthan gum (E415), iron oxide red (E172). Only for 20 mg film-coated tablets: iron oxide yellow (E172). Only for 40 mg film-coated tablets: iron oxide black (E172). See "Scemblix contains lactose and sodium" in section 2.

Description of the appearance of Scemblix and contents of the pack
Scemblix 20 mg film-coated tablets (tablets): pale yellow, round, biconvex tablets with bevelled edges, approximately 6 mm in diameter, imprinted with the company logo on one side and “20” on the other side.
Scemblix 40 mg film-coated tablets (tablets): white-violet, round, biconvex tablets with bevelled edges, approximately 8 mm in diameter, imprinted with the company logo on one side and “40” on the other side.
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 multiple packs containing 180 (3 packs of 60) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

ANNEX IV
CONCLUSIONS REGARDING THE REQUEST FOR ANNUAL EXTENSION OF
COMMERCIAL PROTECTION SUBMITTED BY THE EUROPEAN MEDICINES
AGENCY
Conclusions submitted by the European Medicines Agency on:

• one-year extension of commercial protection

In consideration of the provisions set out in Article 14(11) of Regulation 726/2004/EC, the Committee for Medicinal Products for Human Use (CHMP) has reviewed the data submitted by the marketing authorization holder and considers that the new therapeutic indication provides a significant clinical benefit compared to currently available therapy(ies), as further described in the European Public Assessment Report (EPAR).