Leuzek

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Leuzek, 100 mg, hard capsules

Imatinib

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

• -You should keep this leaflet, so you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Leuzek and what is it 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 is Leuzek and what is it 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 certain types of tumors. 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 blood cancer. The task of white blood cells is to help the body fight 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 that originates 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 certain 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 certain 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 tumor in which certain 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. If you have any questions about the action of Leuzek or the reasons for prescribing this medicine, you should consult a doctor.

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. You should strictly follow the doctor's recommendations, even if they differ from the general information contained in this leaflet.

When not to take Leuzek:

• if the patient is allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

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 a doctor for advice.

Warnings and precautions

Before starting to take Leuzek, you should discuss it with your doctor.

• if the patient has or has ever had liver, kidney, or heart disease.
• if the patient is taking levothyroxine after thyroid removal.
• if the patient has ever had or may currently have a hepatitis B virus infection; this is because Leuzek may cause the reactivation of hepatitis B virus infection, which can be fatal in some cases; patients will be closely monitored by their doctor for signs of this infection before starting treatment.
• if, while taking Leuzek, the patient experiences bruising, bleeding, fever, fatigue, and disorientation, they should contact their doctor. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA).

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 in 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, during the treatment with this medicine, blood tests and body weight measurements will be performed.

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 Ph-positive ALL in children is limited, and experience with the use of MDS/MPD, DFSP, and HES/CEL in children 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 enhance or weaken the action 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 a doctor before taking this medicine.
• Leuzek should not be used during pregnancy unless it is 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 used 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 a 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 an orange dye

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 recommendations. The medicine should be taken for as long as recommended by the doctor. In case of doubts, the patient should consult a doctor or pharmacist. Leuzek should be taken until the doctor decides to stop the treatment. If the patient cannot take the medicine according to the doctor's recommendations or thinks they no longer need to take the medicine, they should immediately contact their doctor.

Recommended dose

Adult use

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

• In the case of CML treatment in blast crisis:The initial dose is usually 600 mg:
• 600 mg taken as 6 capsules oncea day.

In the case of CML treatment 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 (8 capsules), 4 capsules should be taken in the morning and 4 capsules in the evening.

• In the case of Ph-positive ALL treatment:The initial dose is 600 mg, taken as 6 capsules oncea day.
• In the case of MDS/MPD treatment:The initial dose is 400 mg, taken as 4 capsules oncea day.
• In the case of HES/CEL treatment:The initial dose is 100 mg, taken as one capsule oncea day. The doctor may decide to increase the dose to 400 mg taken as 4 capsules oncea day, depending on the patient's response to treatment.
• In the case of DFSP treatment:The daily dose is 800 mg (8 capsules), taken as 4 capsules in the morning and 4 capsules 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 100 mg capsule) of non-carbonated water or apple juice (mix with a spoon until the contents of the capsule are completely dissolved, and then drink the entire contents of the glass).

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. Wash hands immediately after opening the capsules.

How long to take Leuzek

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

Taking more Leuzek than recommended

In case of accidental ingestion of too many capsules, the patient should immediatelyinform their doctor. The patient may need medical attention. They should take the packaging of the medicine with them.

Missing a dose of Leuzek

• In case of a missed dose, it should be taken as soon as possible, unless it is close to the time for the next dose. In this case, the missed dose should be skipped.
• Then, the patient should continue with their usual dosing schedule.
• The patient should not take a double dose to make up for the missed dose.

In case of any further doubts about taking this medicine, the patient should consult a doctor, pharmacist, or nurse.

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 patient should immediately inform their doctor if they experience 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).
• Infection symptoms, such as fever, severe 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 (symptoms of heart problems).
• Cough, difficulty breathing, or pain while breathing (symptoms of lung problems).
• Dizziness, dizziness, or fainting (symptoms of low blood pressure).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (symptoms 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, elevated red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin problems).
• Severe abdominal pain, presence of blood in vomit, stool, or urine, black stools (symptoms of stomach and intestine disorders).
• Significantly reduced urine output, feeling of thirst (symptoms of kidney problems).
• Nausea with diarrhea and vomiting, abdominal pain, or fever (symptoms of intestinal problems).
• Severe headache, weakness, or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (symptoms of nervous system problems such as bleeding or swelling in the skull/brain).
• Pallor, feeling of fatigue, and shortness of breath, as well as dark urine (symptoms of red blood cell deficiency).
• Eye pain or vision impairment, bleeding in the eye.
• Hip or walking difficulties.
• Numbness or feeling of cold in fingers and toes (symptoms of Raynaud's syndrome).
• Sudden swelling and redness of the skin (symptoms of skin infection called cellulitis).
• Hearing difficulties.
• Muscle weakness and muscle cramps with irregular heartbeat (symptoms of changes in the patient's blood potassium levels).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps accompanied by fever, reddish-brown urine, pain, or muscle weakness (symptoms of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting caused by low blood pressure (symptoms of problems in the ovaries or uterus).
• Nausea, shortness of breath, irregular heartbeat, clouded 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 nodules 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 (symptoms of allergic reaction related to treatment) with shortness of breath, chest pain/discomfort, significantly reduced urine output, and feeling of thirst, etc. (symptoms of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) 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 immediately tell their doctor.

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 treatment with Leuzek.
• Swelling, e.g., swelling of the ankles or around the eyes.
• Weight gain. If any of these symptoms occur severely, the patient should tell their doctor.

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

• Lack of appetite, weight loss, or taste disorders.
• Dizziness or weakness.
• Sleep disturbances (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 patient should tell their doctor.

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

• Redness and (or) swelling of the hands and soles of the feet, 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 patient should tell their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. 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 Tel.: +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 packaging that is damaged or shows signs of opening. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist 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 100 mg of imatinib in the form of imatinib mesylate.
• Other ingredients are: capsule shell: gelatin, titanium dioxide, ink with the composition: shellac, concentrated ammonia, propylene glycol, orange yellow.

What Leuzek looks like and what the pack contains

100 mg: hard gelatin capsules, white or almost white, with the imprint "100". Pack size: 60 or 120 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