Nilotinib Zentiva
Nilotinib Zentiva is a medicine used to treat a type of blood cancer called chronic myeloid leukemia (CML), where the body produces too many abnormal white blood cells.
Form
kapseli, kova
Strength
200 mg
Active Ingredient
Nilotinib
Manufacturer
Zentiva k.s.
How to Use
Dosage
For newly diagnosed CML, the recommended dose is 600 mg per day (two 150 mg capsules twice daily). If previous treatment is no longer effective, the recommended dose is 800 mg per day (two 200 mg capsules twice daily).
Method
Swallow the capsules whole with water. Do not eat any food for 2 hours before or 1 hour after taking the medicine. Do not open the capsules.
Important
The maximum daily dose for children and adolescents is 800 mg. For adults, the dose is 600 mg or 800 mg depending on the condition.
Possible Side Effects
COMMON
- •Diarrhea
- •Headache
- •Lack of energy (fatigue)
- •Muscle pain
- •Itching and rash
- •Nausea
- •Constipation
- •Vomiting
- •Hair loss
- •Pain in arms, legs, bones, or back when treatment is stopped
- •Slower growth in children and adolescents
- •Upper respiratory infection (e.g., sore throat, runny/stuffy nose, sneezing)
- •Low levels of red blood cells, platelets, or hemoglobin
- •High lipase levels in blood (pancreas function)
- •High bilirubin levels in blood (liver function)
- •High ALAT levels in blood (liver enzyme)
RARE
- •Pneumonia
- •Abdominal pain, discomfort after eating, gas, swollen or bloated stomach
- •Bone pain, muscle cramps
- •Pain (including neck pain)
- •Dry skin, acne, reduced skin sensation
- •Weight loss or gain
- •Insomnia, depression, anxiety
- •Night sweats, heavy sweating
- •General feeling of being unwell
- •Nosebleeds
- •Signs of gout (joint pain and swelling)
- •Difficulty getting or keeping an erection
- •Flu-like symptoms
- •Sore throat
- •Bronchitis
- •Ear pain, ringing or buzzing in the ears (tinnitus)
- •Hemorrhoids
- •Heavy menstrual bleeding
- •Itchy hair follicles
- •Oral or vaginal yeast infection
- •Conjunctivitis (watery, itchy, red, swollen eyes)
- •Eye irritation and redness
- •High blood pressure (headache, dizziness)
- •Redness
- •Peripheral artery disease (leg pain, weakness, cramps, slow-healing sores, skin color or temperature changes in limbs)
- •Shortness of breath
- •Mouth sores and gum inflammation
- •High amylase levels in blood (pancreas function)
- •High creatinine levels in blood (kidney function)
- •High alkaline phosphatase or creatine kinase levels in blood
- •High ASAT levels in blood (liver enzyme)
- •High gamma-glutamyl transferase levels in blood (liver enzyme)
- •Low white blood cell count (leukopenia or neutropenia)
- •Increased platelet or white blood cell count
- •Low levels of magnesium, potassium, sodium, calcium, or phosphorus in blood
- •High levels of potassium, calcium, or phosphorus in blood
- •High fat levels in blood (e.g., cholesterol)
- •High uric acid levels in blood
- •Allergy (hypersensitivity to Nilotinib Zentiva)
- •Dry mouth
- •Breast pain
- •Pain or discomfort in the side of the body
- •Increased appetite
- •Enlarged breasts in men (gynecomastia)
- •Herpes virus infection
- •Muscle and joint stiffness, swollen joints
- •Feeling changes in body temperature (hot flashes, chills)
- •Taste changes
- •Frequent urination
- •Stomach lining inflammation (abdominal pain, nausea, vomiting, diarrhea, bloating)
- •Memory loss
- •Skin cysts, thinning/thickening/discoloration of skin
- •Psoriasis (thickened, red/silver skin patches)
- •Increased skin sensitivity to light (photosensitivity)
- •Hearing problems
- •Joint inflammation
- •Urinary incontinence
- •Bowel inflammation (enterocolitis)
- •Anal abscess
- •Swollen nipples
- •Restless legs syndrome
- •Sepsis (blood poisoning)
- •Skin infection (e.g., boils)
- •Warts
- •Increased eosinophils (a type of white blood cell)
- •Lymphopenia (low white blood cell count)
- •High parathyroid hormone levels
- •High lactate dehydrogenase levels (an enzyme)
- •Low blood sugar (nausea, sweating, weakness, dizziness, tremors, headache)
- •Dehydration
- •Abnormal blood fat levels
- •Involuntary tremors
- •Difficulty concentrating
- •Abnormal sensations to touch (dysesthesia)
- •Fatigue
- •Numbness or tingling in fingers and toes (peripheral neuropathy)
- •Facial muscle paralysis
- •Bleeding in the white of the eye
- •Eye bleeding
- •Heart attack (sudden chest pain, fatigue, irregular heartbeat)
- •Heart murmur (fatigue, chest discomfort, dizziness, palpitations)
- •Athlete's foot (fungal infection)
- •Heart failure (shortness of breath, difficulty breathing when lying down, swollen feet or legs)
- •Pain behind breastbone (pericarditis)
- •Hypertensive crisis (severe headache, dizziness, nausea)
- •Leg pain and weakness when walking (intermittent claudication)
- •Limb artery narrowing (high blood pressure, painful cramps in hips/thighs/calves after activity, numbness/weakness in legs)
- •Bruising (without injury)
- •Arteriosclerosis (fat buildup in arteries)
- •Low blood pressure (dizziness, lightheadedness, fainting)
- •Lung edema (shortness of breath)
- •Pleural effusion (fluid around lungs, chest pain, cough, hiccups, rapid breathing)
- •Interstitial lung disease (cough, breathing difficulty, painful breathing)
- •Pleurisy (chest pain)
- •Pleuritis (cough, painful breathing)
- •Hoarseness
- •Pulmonary hypertension (high blood pressure in lung arteries)
- •Wheezing
- •Sensitive teeth
- •Gingivitis (bleeding, sore, or swollen gums)
- •High urea levels in blood (kidney function)
- •Changes in blood protein levels (low globulins or paraprotein)
- •High unconjugated bilirubin levels in blood
- •High troponin levels in blood
- •Redness, swelling, and possibly peeling of palms and soles (hand-foot syndrome)
- •Warts in the mouth
- •Hardness or stiffness in breasts
- •Thyroid inflammation (thyroiditis)
- •Mood changes or depression
- •Overactive parathyroid gland (bone/joint pain, excessive urination, abdominal pain, weakness, fatigue)
- •Brain artery narrowing (partial/total vision loss in one/both eyes, double vision, vertigo, numbness/tingling, poor coordination, dizziness, confusion)
- •Brain swelling (headache and/or mental changes)
- •Optic nerve inflammation (blurred vision or vision loss)
- •Heart dysfunction (reduced ejection fraction) (fatigue, chest discomfort, dizziness, pain, palpitations)
- •Low or high insulin levels in blood (hormone regulating blood sugar)
- •Low C-peptide levels in blood (measure of pancreas function)
- •Sudden death
Important Warnings
- Do not take if you are allergic to nilotinib or any other ingredients in the medicine.
- Tell your doctor if you have had heart or blood vessel problems, like a heart attack or stroke.
- Inform your doctor about any heart conditions, especially if you have an abnormal electrical signal in your heart (long QT interval).
- Tell your doctor about all medicines you take, including those for cholesterol, heart rhythm, or liver problems, as they can interact with Nilotinib Zentiva.
- Let your doctor know if you have low potassium or magnesium levels.
Show 12 more warnings
- Inform your doctor if you have liver or pancreas problems.
- Tell your doctor if you bruise easily, feel very tired, get short of breath, or have repeated infections.
- Let your doctor know if you have had your entire stomach removed by surgery.
- Tell your doctor if you have ever had or might have Hepatitis B, as this medicine can reactivate it.
- Contact your doctor immediately if you faint or have an irregular heartbeat, as these can be signs of serious heart problems.
- Seek urgent medical help if you experience sudden heart palpitations, severe muscle weakness, paralysis, seizures, or sudden changes in your thinking or awareness, as these could be signs of tumor lysis syndrome.
- Report immediately to your doctor any chest pain or discomfort, numbness or weakness, difficulty walking or speaking, pain, discoloration or coldness in a limb, as these may indicate heart or blood vessel issues.
- Tell your doctor if your feet or hands swell, you have general swelling, or if you gain weight quickly, as this can be a sign of fluid buildup.
- Do not take Nilotinib Zentiva with food or grapefruit, as this can increase the medicine's effects and cause harm.
- This medicine is not recommended during pregnancy or breastfeeding. Use effective birth control if you can become pregnant.
- Avoid driving or operating machinery if you experience dizziness or vision problems.
- This medicine contains lactose. If you have an intolerance to some sugars, discuss with your doctor.