Leuzek

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Leuzek, 400 mg, hard capsules

Imatinib

Before taking the medicine, carefully read the contents of this leaflet, as it contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Leuzek is and what it is used for

Leuzek is available in the form of hard gelatin capsules containing the active substance imatinib. The medicine works by inhibiting the growth of abnormal cells in the diseases listed below, including some types of cancer.

Leuzek is used in adults, children, and adolescents to treat the following diseases:

• Chronic myeloid leukemia (CML - English Chronic Myeloid Leukaemia) in blast crisis. Leukemia is a cancer of white blood cells. The task of white blood cells is to support the body in fighting infections. Chronic myeloid leukemia is one of the forms of leukemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably. Blast crisis is the most advanced stage of this disease.
• Acute lymphoblastic leukemia with Philadelphia chromosome (English Ph-positive ALL). Leukemia is a cancer originating from white blood cells. Usually, white blood cells help the body fight infections. Acute lymphoblastic leukemia is a type of leukemia in which certain abnormal white blood cells (called lymphoblasts) begin to multiply uncontrollably. Leuzek inhibits the growth of these cells.

Leuzek is also used in children and adolescents to treat:

• Newly diagnosed CML, in whom bone marrow transplantation is not considered in first-line treatment;
• CML in the chronic phase after failure of interferon alpha treatment, or in the accelerated phase. The accelerated phase is a transitional phase between the chronic phase and blast crisis. This phase is considered the first sign of resistance to treatment.

Leuzek is also indicated for the treatment of adult patients with:

• Myelodysplastic/myeloproliferative syndromes (MDS/MPD - English myelodysplastic/myeloproliferate). These are blood diseases in which some white blood cells begin to multiply uncontrollably. Leuzek inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES - English Hypereosinophilic Syndrome) and (or) chronic eosinophilic leukemia (CEL - English Chronic Eosinophilic Leukemia). These are blood diseases in which some blood cells (called eosinophils) begin to multiply uncontrollably. Leuzek inhibits the growth of these cells in certain subtypes of these diseases.
• Dermatofibrosarcoma protuberans (DFSP - English dermatofibrosarcoma protuberans). DFSP is a skin and subcutaneous tissue cancer in which some cells begin to multiply uncontrollably. Leuzek inhibits the growth of these cells.

In the rest of the leaflet, abbreviated names of these diseases are used.

In case of questions about the action of Leuzek or the reasons for prescribing this medicine, the doctor should be consulted.

2. Important information before taking Leuzek

Leuzek may only be prescribed by a doctor with experience in using medicines for the treatment of blood cancers.

The doctor's instructions should be followed strictly, even if they differ from the general information contained in this leaflet.

When not to take Leuzek:

If this information applies to the patient, they should tell their doctor before taking the medicine

Leuzek.

If the patient thinks they may be allergic, but is not sure, they should consult their doctor for advice.

Warnings and precautions

Before starting to take Leuzek, the patient should discuss the following with their doctor:

If any of the above points apply to the patient, they should inform their doctor before taking Leuzek.

During treatment with Leuzek, the patient may become more sensitive to the sun. It is essential to cover exposed skin areas and use sunscreens with a high sun protection factor (SPF). These precautions should also be taken by children.

During treatment with Leuzek, the patient should immediately inform their doctorif they experience rapid weight gain. Leuzek may cause fluid retention in the body (severe fluid retention).

During treatment with Leuzek, the doctor will regularly examine the patient to check if the treatment with Leuzek is effective. Additionally, blood tests and body weight measurements will be performed during treatment with this medicine.

Children and adolescents

Leuzek is also used to treat children and adolescents with CML. There is limited data on the treatment of children with CML under 2 years of age. Experience with the use of Leuzek in children with Ph-positive ALL is limited, and experience with the use of Leuzek in children with MDS/MPD, DFSP, and HES/CEL is very limited.

In some children and adolescents taking Leuzek, growth may be slower than normal. The doctor will monitor growth during regular visits.

Leuzek and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that are available without a prescription (e.g., paracetamol) and herbal medicines (e.g., St. John's Wort). Some medicines may affect the action of Leuzek if taken at the same time. They may increase or decrease the effect of Leuzek, which can lead to increased side effects or make Leuzek less effective. Similarly, Leuzek may affect some other medicines.

The patient should tell their doctor if they are taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
• Leuzek should not be taken during pregnancy unless absolutely necessary, as it may harm the baby. The doctor will inform the patient about the potential risks associated with taking Leuzek during pregnancy.
• Women who may become pregnant should use effective contraception during treatment with Leuzek and for 15 days after the end of treatment.
• Leuzek should not be taken during breastfeeding and for 15 days after the end of treatment, as it may harm the baby.
• Patient concerned about their fertility during treatment with Leuzek should consult their doctor.

Driving and using machines

The patient may experience dizziness or drowsiness or have blurred vision while taking this medicine. In such cases, they should avoid driving and operating machines until they feel better.

Leuzek contains a dye called orange yellow (E110)

The dye contained in this medicine may cause allergic reactions.

3. How to take Leuzek

The doctor has prescribed Leuzek because of the patient's serious condition. Leuzek may help improve this condition.

This medicine should always be taken according to the doctor's or pharmacist's instructions. The medicine should be taken for as long as the doctor recommends.

Leuzek should be taken until the doctor decides to stop the treatment. If the patient cannot take the medicine according to the doctor's instructions or thinks they no longer need to take the medicine, they should contact their doctor immediately.

Recommended dose

Adult use

The doctor will determine exactly how many Leuzek capsules to take.

• In the case of CML in blast crisis:The initial dose is usually 600 mg:
• 600 mg taken as one 400 mg capsule plus 2 100 mg capsules oncea day.

In the case of CML in blast crisis, the doctor may prescribe a higher or lower dose depending on the patient's response to treatment. If the daily dose is 800 mg (2 capsules), the patient should take 1 capsule in the morning and 1 capsule in the evening.

• In the case of Ph-positive ALL:The initial dose is 600 mg, taken as one 400 mg capsule plus 2 100 mg capsules oncea day.
• In the case of MDS/MPD:The initial dose is 400 mg, taken as one capsule oncea day.
• In the case of HES/CEL:The initial dose is 100 mg, taken as one 100 mg capsule oncea day. The doctor may decide to increase the dose to 400 mg, taken as one 400 mg capsule oncea day, depending on the patient's response to treatment.
• In the case of DFSP:The daily dose is 800 mg (2 capsules), taken as one capsule in the morning and one capsule in the evening.

Use in children and adolescents

The doctor will determine how many Leuzek capsules to give to the child. The amount of Leuzek depends on the child's condition, body weight, and growth. The total daily dose for children and adolescents should not exceed 800 mg in the treatment of CML and 600 mg in the treatment of Ph-positive ALL. The dose can be taken once a day or divided into two doses (half in the morning and half in the evening).

When and how to take Leuzek

• Leuzek should be taken with food, which will help protect the patient from stomach problems while taking Leuzek.
• The capsules should be swallowed whole, with a large glass of water.Do not open, crush, or chew the capsules unless the patient has swallowing problems (e.g., in children).
• If the patient cannot swallow the capsules, the contents of the capsule can be dissolved in approximately 50 ml (for a 400 mg capsule) or 200 ml (for a 400 mg capsule) of non-carbonated water

or apple juice (mix with a spoon until the capsule contents are completely dissolved, then drink the entire contents of the glass immediately).

• Women who are pregnant or may become pregnant and who open the capsules should handle the contents carefully: avoid skin and eye contact and do not inhale the powder. Hands should be washed immediately after opening the capsules.

How long to take Leuzek

Leuzek should be taken every day, for as long as the doctor recommends.

Taking a higher dose of Leuzek than recommended

In case of accidental ingestion of too many capsules, the doctor should be informed immediately. The patient may need medical attention. The medicine packaging should be taken along.

Missing a dose of Leuzek

• In case of a missed dose, it should be taken as soon as possible, unless it is almost time for the next dose. In this case, the missed dose should be skipped.
• The usual dosing schedule should be continued.
• A double dose should not be taken to make up for a missed dose.

In case of any further doubts about taking this medicine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicines, Leuzek can cause side effects, although not everybody gets them. They are usually mild to moderate.

Some side effects may be serious. The doctor should be informed immediately if the patient experiences any of the following symptoms:

Very common(more than 1 in 10 patients) or common(less than 1 in 10 patients) side effects:

• Rapid weight gain. Leuzek may cause fluid retention in the body (severe fluid retention).
• Signs of infection, such as fever, chills, sore throat, and mouth ulcers. Leuzek may decrease the number of white blood cells in the blood, making the patient more prone to infections.
• Unexpected bleeding or bruising (even without injury).

Uncommon(less than 1 in 100 patients) or rare(less than 1 in 1000 patients) side effects:

• Chest pain, irregular heartbeat (signs of heart problems).
• Cough, difficulty breathing, or chest pain (signs of lung problems).
• Feeling of emptiness in the head, dizziness, or fainting (signs of low blood pressure).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (signs of liver disease).
• Rash, redness of the skin with blisters on the lips, around the eyes, on the skin, or in the mouth, peeling of the skin, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (signs of skin problems).
• Severe abdominal pain, blood in vomit, stool, or urine, black stools (signs of stomach and intestine problems).
• Significantly reduced urine output, feeling of thirst (signs of kidney problems).
• Nausea with diarrhea and vomiting, abdominal pain, or fever (signs of intestine problems).
• Severe headache, weakness, or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in the skull/brain).
• Pale skin, feeling of tiredness and shortness of breath, and dark urine (signs of red blood cell deficiency).
• Eye pain or vision problems, bleeding in the eye.
• Hip or walking difficulties.
• Numbness or feeling of cold in the fingers (signs of Raynaud's syndrome).
• Sudden swelling and redness of the skin (signs of skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and cramps with irregular heartbeat (signs of changes in the patient's blood potassium levels).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps with fever, reddish-brown urine, muscle pain, or weakness (signs of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting due to low blood pressure (signs of problems with the ovaries or uterus).
• Nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and (or) joint problems with abnormal laboratory test results (e.g., high potassium, uric acid, and calcium levels and low phosphorus levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).
• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the fatty tissue under the skin).

Frequency not known(cannot be estimated from the available data):

• Co-occurrence of widespread, severe rash, nausea, fever, high levels of certain white blood cells, or yellowing of the skin or eyes (jaundice) with shortness of breath, chest pain/discomfort, significantly reduced urine output, and thirst, etc. (signs of an allergic reaction related to treatment).
• Chronic kidney failure.
• Reactivation (recurrence) of hepatitis B virus infection (liver infection) in patients who have had this disease in the past.

If the patient experiences any of the above side effects, they should inform their doctor immediately.

Other side effects may include: Very common side effects (more than 1 in 10 patients) :

• Headache or fatigue.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps, muscle pain, or bone pain, during or after taking Leuzek.
• Swelling, e.g., swelling of the ankles or eyes.
• Weight gain. If any of these symptoms occur severely, the doctor should be informed.

Common side effects(less than 1 in 10 patients) :

• Lack of appetite, weight loss, or taste disorders.
• Dizziness or weakness.
• Sleep disorders (insomnia).
• Eye discharge with itching, redness, and swelling (conjunctivitis), increased tearing, or blurred vision.
• Nosebleeds.
• Abdominal pain or swelling, bloating with gas, heartburn, or constipation.
• Itching.
• Excessive hair loss or thinning.
• Numbness of hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flashes, chills, or night sweats. If any of these symptoms occur severely, the doctor should be informed.

Frequency not known(frequency cannot be estimated from the available data) :

• Redness and (or) swelling of the palms and soles, which may be accompanied by a feeling of tingling and burning pain.
• Skin changes with pain and (or) blistering.
• Slowed growth in children and adolescents.

If any of the above symptoms worsen, the doctor should be informed.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Poland

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Leuzek

The medicine should be stored out of sight and reach of children.

Store in a temperature below 30°C.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.

Do not use damaged or opened packaging.

Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Leuzek contains

• The active substance of Leuzek is imatinib. Each Leuzek capsule contains 400 mg of imatinib in the form of imatinib mesylate.
• Other ingredients are: capsule shell ingredients: gelatin, titanium dioxide, ink with the composition: shellac, concentrated ammonia, propylene glycol, orange yellow.

What Leuzek looks like and what the pack contains

400 mg: hard gelatin capsules, white or almost white, with the imprint "400".

Package size: 30 capsules.

Marketing authorization holder

Nobilus Ent Tomasz Koźluk

ul. Swarzewska 45

01-821 Warsaw

Poland

Manufacturer

NOBILUS ENT

ul. Swarzewska 45

01-821 Warsaw

Poland

Date of last revision of the leaflet