Nibix

Leaflet accompanying the packaging: patient information

Nibix, 400 mg, hard capsules

Imatinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your 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. Contents of the pack 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 (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. 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 arises from the 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 mentioned above will be used. If you have any questions about how Nibix works or why it has been prescribed for you, you should ask your doctor.

2. Important information before taking Nibix

Nibix is prescribed to patients only by doctors with experience in using medicines for the treatment of blood cancers or solid tumors. You must follow the doctor's instructions carefully, even if they differ from the general information contained in this leaflet.

When not to take Nibix

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

If this information applies to you, you should tell your doctor before taking the medicine

Nibix.

If you suspect an allergy but are not sure, you should consult your doctor.

Warnings and precautions

Before starting treatment with Nibix, you should discuss the following with your doctor:

• if you have or have ever had liver, kidney, or heart disease.
• if you are taking levothyroxine after thyroid removal.
• if you have or may have had hepatitis B virus infection; this is because Nibix may cause reactivation of hepatitis B virus infection, which can be life-threatening in some cases; patients will be closely monitored by their doctor for signs of this infection before starting treatment.
• if you experience bruising, bleeding, fever, fatigue, and disorientation while taking Nibix, you should contact your doctor. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA). If any of the above points apply to you, you should tell your doctor before taking Nibix.

While taking Nibix, you may become more sensitive to the sun. It is important to cover areas of skin exposed to the sun and use sunscreens with a high sun protection factor (SPF). These precautions should also be taken by children. You should tell your doctor immediately if you experience rapid weight gain during treatment with Nibix.Nibix may cause water retention in the body (severe fluid retention). Your doctor will regularly check your health to see if the treatment is working. Blood tests and weight measurements will be regularly performed while you are 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. Your doctor will check your growth during regular visits.

Nibix and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, 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 way Nibix works, or Nibix may affect the way other medicines work. They may increase or decrease the effect of Nibix, which may lead to increased side effects or make Nibix less effective. Similarly, Nibix may affect some other medicines. Tell your doctor if you are taking medicines to prevent blood clots.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
• Nibix is not recommended for women who are pregnant, unless clearly necessary, as it may harm the baby. Your doctor will discuss the possible risks and benefits of taking Nibix during pregnancy.
• Women who may become pregnant should use effective contraception during treatment with Nibix and for 15 days after stopping treatment.
• Do not breastfeed while taking Nibix and for 15 days after stopping treatment, as this may harm the baby.
• Patients concerned about their fertility while taking Nibix should consult their doctor.

Driving and using machines

While taking Nibix, you may experience dizziness or drowsiness or vision disturbances. In this case, do not drive or operate any tools or machines until you feel better.

Nibix contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, inform your doctor before taking Nibix.

3. How to take Nibix

Your doctor has prescribed Nibix for you because of your serious condition. Nibix may help improve your condition. However, you should always take Nibix as directed by your doctor or pharmacist. It is important to take the medicine for as long as your doctor or pharmacist tells you. If you are unsure, ask your doctor or pharmacist. Do not stop taking Nibix unless your doctor tells you to. If you cannot take the prescribed dose or think you do not need it, you should contact your doctor immediately.

What dose of Nibix to take

Adult patients

Your doctor will decide on the exact number of Nibix capsules you should take.

• In the case of CML treatment:Depending on your condition, the initial dose is usually 400 mg or 600 mg:
• 400 mgtaken as one capsule oncea day,
• 600 mgtaken as one 400 mg capsule plus 2 100 mg capsules oncea day.
• In the case of GIST treatment:The initial dose is 400 mg, taken oncea day.

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

• In the case of Ph-positive ALL treatment: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 treatment:The initial dose is 400 mg, taken as one capsule oncea day.
• In the case of HES/CEL treatment:The initial dose is 100 mg, taken as one 100 mg capsule oncea day. Your doctor may decide to increase the dose to 400 mg taken as one 400 mg capsule oncea day, depending on your response to treatment.
• In the case of DFSP treatment:The daily dose is 800 mg (2 capsules), taken as 1 capsule in the morning and 1 capsule in the evening.

Children and adolescents

Your doctor will decide on the number of Nibix capsules to give to your child. The dose of Nibix will depend on your child's condition, weight, and height. 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, with a large glass of water.Do not open or crush the capsules unless you have problems swallowing them (e.g., children).
• If you are unable to swallow the capsules, you can open them and mix the powder with a glass of still water or apple juice.
• Pregnant or breastfeeding women should be careful when opening the capsules. Avoid contact between the capsule contents and your eyes and avoid inhaling the contents. Wash your hands immediately after opening the capsule.

How long to take Nibix

You should take Nibix every day for as long as your doctor tells you.

Taking more Nibix than prescribed

If you have taken more capsules than prescribed, you should immediatelytell your doctor, as you may need medical attention. Take the packaging with you.

Missing a dose of Nibix

• If you forget to take a dose, you should take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Then continue with your usual dosing schedule.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about taking this medicine, ask your 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. You should tell your doctor immediately if you 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 chest pain (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, raised red or purple spots on the skin, itching, burning sensation, blistering 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 intestine 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).
• Pale skin, feeling of tiredness and shortness of breath, and dark urine (symptoms of anemia).
• Eye pain or vision problems, 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 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, pain, and 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, 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).

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 of hepatitis B virus infection (liver infection) in patients who have had the disease in the past.

If you experience any of the above side effects, you should tell your doctor immediately.

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, you should tell your 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, 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, you should tell your doctor.

Uncommon(may affect less than 1 in 100 people):

• Painful red lumps on the skin, skin pain, redness of the skin (inflammation of the fatty tissue under the skin).
• 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 with a pulsating sensation, usually on one side of the head, which may be accompanied by nausea, vomiting, and sensitivity to light or sound (symptoms of migraine).
• Flu-like symptoms (flu).
• Pain or burning sensation when urinating, elevated body temperature, pain in the groin or pelvic area, red or brown urine, or cloudy urine (symptoms of urinary tract infection).
• Joint pain or swelling (symptoms of joint pain).
• Feeling of sadness and loss of interest, preventing you from performing daily activities (symptoms of depression).
• Feeling of anxiety or apprehension with physical symptoms, such as rapid heartbeat, sweating, trembling, dry mouth (symptoms of anxiety).
• Drowsiness/excessive drowsiness.
• Trembling or muscle twitching.
• Memory disturbances.
• Irrepressible urge 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.
• Mouth ulcers.
• Difficulty swallowing.
• Increased sweating.
• Discoloration of the skin.
• Brittle nails.
• Red bumps or white pimples forming around hair roots, which may cause pain, itching, or burning sensation (symptoms of folliculitis).
• Skin rash with peeling skin (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull pain and (or) feeling of heaviness in the testicles or in the lower abdomen, pain when urinating, during sexual intercourse, or during ejaculation, blood in the urine (symptoms of testicular swelling).
• Difficulty achieving or maintaining an erection (erectile dysfunction).
• Heavy or irregular menstrual bleeding.
• Difficulty achieving or maintaining sexual arousal.
• Decreased libido.
• Breast tenderness.
• General feeling of being unwell.
• Viral infection, such as a cold.
• Back pain due to kidney problems.
• Increased frequency of urination.
• Increased appetite.
• 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, you should tell your doctor.

Rare(may affect less than 1 in 1,000 people):

• Confusion
• Seizure (seizures) and decreased consciousness (seizures).
• Discoloration of the 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 pain.
• Skin changes with pain and (or) blistering.
• Slowed growth in children and adolescents.

If any of the above side effects worsen, you should tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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, you can help provide more information on the safety of this 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 words "Expiry date (EXP):". The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Do not use the medicine if the packaging is damaged or shows signs of opening.

Medicines should not be disposed of via wastewater or household waste. Ask your 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 Nibix contains

• The active substance is imatinib (as mesilate). Each Nibix capsule contains 400 mg of imatinib (as mesilate).
• The 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 contents of the pack

Nibix, 400 mg, hard capsules are caramel-colored gelatin capsules, size "00". They are available in packs of 10, 30, 90, or 100 capsules. Not all pack sizes may be available in your 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 further information on this medicine, you 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 400 mg hard capsule
Date of last revision of the leaflet:07.2024