Nibix

Leaflet accompanying the packaging: patient information

Nibix, 100 mg, hard capsules

Imatinib

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

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, please 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 Nibix and what is it used for
• 2. Important information before taking Nibix
• 3. How to take Nibix
• 4. Possible side effects
• 5. How to store Nibix
• 6. Package contents and other information

1. What is Nibix and what is it used for

Nibix is a medicine that contains the active substance imatinib. This medicine works by inhibiting the growth of abnormal cells in the course of the diseases listed below. These include certain types of cancer.

Nibix is indicated for the treatment of adult patients and children with:

• Chronic myeloid leukemia (CML)- English: Chronic Myeloid Leukaemia). Leukemia is a cancer that originates from white blood cells. Usually, white blood cells help the body fight infections. Chronic myeloid leukemia is a type of leukemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably.
• Acute lymphoblastic leukemia with Philadelphia chromosome (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. Nibix inhibits the growth of these cells.

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

• Myelodysplastic/myeloproliferative syndromes (MDS/MPD)- English: myelodysplastic/myeloproliferate). These are blood disorders in which certain white blood cells begin to multiply uncontrollably. Nibix 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 disorders in which certain blood cells (called eosinophils) begin to multiply uncontrollably. Nibix inhibits the growth of these cells in certain subtypes of these diseases.
• Gastrointestinal stromal tumors (GIST)- English: Gastrointestinal Stromal Tumours), GIST is a tumor of the stomach and intestines. It occurs as a result of uncontrolled growth of connective tissue cells of these organs.
• Dermatofibrosarcoma protuberans (DFSP)- English: dermatofibrosarcoma protuberans). DFSP is a skin and subcutaneous tissue tumor, in which certain cells begin to multiply uncontrollably. Nibix inhibits the growth of these cells.

In the rest of the leaflet, abbreviations of the disease names listed above will be used. If you have any questions about how Nibix works or its justification, you should consult a doctor.

2. Important information before taking Nibix

Nibix is prescribed to patients only by doctors with experience in using medicines used to treat blood cancers or solid tumors. You should strictly follow the doctor's recommendations, even if they differ from the general information contained in this leaflet.

When not to take Nibix

• 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

Nibix.

In case of suspected allergy, but uncertainty, the patient should consult a doctor.

Warnings and precautions

Before starting treatment with Nibix, the patient should discuss with their 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 or may have a hepatitis B virus infection; this is because Nibix may cause 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 the patient experiences bruising, bleeding, fever, fatigue, and disorientation while taking Nibix, 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 tell their doctor before taking Nibix. During treatment with Nibix, the patient may become more sensitive to the sun. It is essential to cover exposed skin areas and use high-protection sunscreens (SPF). These precautions should also be taken by children. The patient should immediately tell their doctor if they experience rapid weight gain during treatment with Nibix. Nibix may cause water retention in the body (severe fluid retention). During treatment with Nibix, the patient's health will be regularly evaluated by their doctor to determine if the treatment is effective. Blood tests and weight measurements will be regularly performed while taking this medicine.

Children and adolescents

Nibix is also used to treat children with CML. There is no experience with the use of Nibix in children with CML under 2 years of age. Experience with the use of Nibix in children with Ph-positive ALL is limited, and experience with the use of Nibix in children with MDS/MPD, DFSP, GIST, and HES/CEL is very limited. In some children and adolescents taking Nibix, growth may be slower than normal. The doctor will monitor growth during regular visits.

Nibix and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription (such as paracetamol) and herbal medicines (such as St. John's Wort). Some medicines may affect the action of Nibix if taken at the same time. They may enhance or weaken the action of Nibix, which can lead to increased side effects or make Nibix less effective. Similarly, Nibix 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.
• Nibix is not recommended for pregnant women unless it is absolutely necessary, as it may harm the baby. The doctor will discuss the possible risks that may occur during treatment with Nibix during pregnancy.
• Women who may become pregnant should use effective contraception during treatment with Nibix and for 15 days after the end of treatment.
• Women should not breastfeed during treatment with Nibix and for 15 days after the end of treatment, as it may harm the baby.
• Patients concerned about their fertility during treatment with Nibix should consult their doctor.

Driving and using machines

While taking Nibix, the patient may experience dizziness or drowsiness, or vision disturbances. In this case, they should not drive or operate any tools or machines until they feel better again. Nibix contains lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should inform their doctor before taking Nibix.

3. How to take Nibix

The doctor has prescribed Nibix because of the patient's serious condition. Nibix may help improve this condition. However, this medicine should always be taken according to the doctor's or pharmacist's recommendations. It is essential to take the medicine for as long as the doctor or pharmacist recommends. If the patient has any doubts, they should consult their doctor or pharmacist. The patient should not stop taking Nibix unless their doctor recommends it. If the patient cannot take the prescribed medicine or thinks they do not need it, they should contact their doctor immediately.

What dose of Nibix to take

Adult patients

The doctor will determine the exact number of Nibix capsules to take.

• In the case of CML treatment:The initial dose is usually 400 mg or 600 mg
• 400 mgtaken as 4 capsules oncea day,
• 600 mgtaken as 6 capsules oncea day.
• In the case of GIST treatment:The initial dose is 400 mg, taken as 4 capsules oncea day.

In the case of CML and GIST treatment, the doctor may prescribe a higher or lower dose depending on the response to treatment. If the daily dose is 800 mg (8 capsules), the patient should take 4 capsules 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.

Children and adolescents

The doctor will determine the number of Nibix capsules to give to the child. The dose of Nibix will depend on the child's condition, weight, and growth. The total daily dose in children should not exceed 800 mg in CML treatment and 600 mg in Ph-positive ALL treatment. The dose can be given once a day or divided into two doses (half the dose in the morning and half the dose in the evening).

When and how to take Nibix

• Nibix should be taken with foodto protect the stomach while taking Nibix.
• Capsules should be swallowed whole, washed down with a large glass of water.The capsules should not be opened or crushed unless the patient has difficulty swallowing them (e.g., children).
• If the patient is unable to swallow the capsules, they can be opened and the powder dissolved in a glass of non-carbonated water or apple juice.
• Pregnant women or those who may become pregnant 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 Nibix

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

Taking more Nibix than recommended

Patients who have accidentally taken too many capsules should immediately tell their doctor, as they may require medical attention. The patient should take the packaging of the medicine with them.

Missing a dose of Nibix

• If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose.
• Then, they should continue with their regular dosing schedule.
• The patient should not take a double dose to make up for the missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

Some side effects can be serious. The patient should immediately tell their doctor if they experience any of the following side effects:

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

• Rapid weight gain. Nibix may cause water retention in the body (severe fluid retention).
• Infection symptoms, such as fever, chills, sore throat, and mouth ulcers. Nibix may reduce the number of white blood cells in the blood, which can increase the risk of infection.
• Unexpected bleeding or bruising (even without injury).

Uncommon(may affect less than 1 in 100 people) or rare(may affect less than 1 in 1,000 people) :

• Chest pain, irregular heartbeat (symptoms of heart problems).
• Cough, difficulty breathing, or pain when breathing (symptoms of lung problems).
• Feeling of emptiness in the head, dizziness, or fainting (symptoms of low blood pressure).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (symptoms of liver problems).
• 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, bulging red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin problems).
• Severe abdominal pain, blood in vomit, stool, or urine, black stools (symptoms of stomach and intestine problems).
• 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, and dark urine (symptoms of red blood cell deficiency).
• Eye pain or vision disturbances, bleeding in the eyes.
• Bone or joint pain (symptoms of bone necrosis).
• Blisters on the skin or mucous membranes (symptoms of pemphigus).
• Numbness or feeling of cold in the 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 cramps with irregular heartbeat (symptoms of changes in potassium levels in the blood).
• Bruising.
• Abdominal pain with nausea.
• Muscle cramps with fever, reddish-brown urine, muscle pain, or weakness (symptoms of muscle problems).
• Pelvic pain, sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting due to low blood pressure (symptoms of ovarian or uterine problems).
• Nausea, shortness of breath, irregular heartbeat, clouding of 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).

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 feeling of thirst, etc. (symptoms of 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 immediately tell their doctor.

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

• Headache or fatigue.
• Nausea, vomiting, diarrhea, indigestion.
• Rash.
• Muscle cramps or joint pain, muscle pain, or bone pain during or after taking Nibix.
• Swelling, such as swelling of the ankles or around the eyes.
• Weight gain. If any of the above side effects worsen, the patient should tell their doctor.

Common(may affect less than 1 in 10 people) :

• Lack of appetite, weight loss, or taste disturbances.
• Dizziness or weakness.
• Sleep disturbances (insomnia).
• Eye discharge with itching, redness, and swelling, excessive tearing, and blurred vision (conjunctivitis), nasal congestion.
• Nosebleeds.
• Abdominal pain or swelling, gas, bloating, 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 the above side effects worsen, the patient should tell their doctor.

Uncommon(may affect no more than 1 in 100 people):

• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the subcutaneous fat tissue).
• Cough, runny nose, or stuffy nose, feeling of pressure or pain when pressing on the area above the eyes or on both sides of the nose, nasal congestion, sneezing, sore throat, which may be accompanied by headache or not (symptoms of upper respiratory tract infection).
• Severe headache felt as a pulsating pain or a feeling of pulsation, usually on one side of the head, which is often accompanied by nausea, vomiting, and sensitivity to light or sounds (symptoms of migraine).
• Flu-like symptoms (flu).
• Pain or burning sensation when urinating, elevated body temperature, pain in the groin or pelvic area, reddish-brown urine, or cloudy urine (symptoms of urinary tract infection).
• Joint pain or swelling (joint pain).
• Feeling of sadness and loss of interest, preventing the patient from performing daily activities (symptoms of depression).
• Feeling of anxiety or apprehension with somatic symptoms, such as rapid heartbeat, sweating, trembling, dry mouth (symptoms of anxiety).
• Drowsiness/excessive drowsiness.
• Trembling or muscle twitching.
• Memory disturbances.
• Irrepressible need to move legs (restless legs syndrome).
• Hearing noises (e.g., ringing, buzzing) in the ears that do not come from outside (tinnitus).
• High blood pressure (hypertension).
• Belching.
• Stomatitis.
• Difficulty swallowing.
• Excessive sweating.
• Discoloration of the skin.
• Brittle nails.
• Red bumps or white pimples forming around hair roots, which can cause pain, itching, or burning sensation (symptoms of folliculitis).
• Skin rash with peeling (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Pelvic pain, sometimes with nausea and vomiting, with sudden vaginal bleeding, dizziness, or fainting due to low blood pressure (symptoms of ovarian or uterine problems).
• Impotence.
• Heavy or irregular menstrual bleeding.
• Difficulty achieving or maintaining sexual arousal.
• Decreased libido.
• Nipple pain.
• General malaise.
• Viral infection, such as a cold.
• Back pain in the lower back due to kidney problems.
• Increased frequency of urination.
• Increased appetite.
• Abdominal pain or burning sensation in the upper abdomen and (or) chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness, and bloating, black stools (symptoms of stomach ulcers).
• Stiffness of joints and muscles.
• Abnormal laboratory test results. If any of the above side effects worsen, the patient should tell their doctor.

Rare(may affect no more than 1 in 1,000 people):

• Confusion
• Seizure (seizures) and decreased consciousness (seizures).
• Discoloration of nails.

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

• Redness or swelling of the palms and soles, which may be accompanied by tingling and burning sensation.
• Skin changes with pain and (or) blistering.
• Slowed growth in children and adolescents. If any of the above side effects worsen, the patient should tell their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Nibix

• The medicine should be stored out of sight and reach of children
• Do not use this medicine after the expiry date stated on the carton and blister after the expression "Expiry date (EXP):". The expiry date refers to the last day of the month.
• Do not store above 30°C.
• Do not use the medicine from damaged or opened packages.

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. Package contents and other information

What Nibix contains

• The active substance is imatinib (in the form of mesylate). Each Nibix capsule contains 100 mg of imatinib (in the form of mesylate).
• Other ingredients are: crospovidone type A, lactose monohydrate, and magnesium stearate.
• The capsule contains gelatin, iron oxide yellow (E 172), titanium dioxide (E 171), and iron oxide red (E 172).

What Nibix looks like and what the package contains

Nibix, 100 mg, hard capsules are orange gelatin capsules, size "3". They are available in packages containing 30, 60, 100, 120, or 180 capsules. Not all pack sizes may be available in the country.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer/Importer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
UAB Norameda
Meistrų 8a, Vilnius LT-02189
Lithuania
Gedeon Richter Plc.
Gyömrői út 19-21., 1103, Budapest
Hungary
To obtain additional information on this medicine, the patient should contact the marketing authorization holder.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland
Nibix
Estonia Glipox
Hungary Nibix 100 mg hard capsule
Date of last revision of the leaflet:07.2024