Nilotinib STADA
Nilotinib Stada is a medicine that treats a type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), which makes your body produce too many abnormal white blood cells.
Form
kapseli, kova
Strength
150 mg
Active Ingredient
Nilotinib hydrochloride dihydrate
Manufacturer
STADA Arzneimittel AG
How to Use
Dosage
For newly diagnosed adults, the recommended dose is 600 mg per day, taken as two 150 mg capsules twice daily. For adults who no longer benefit from previous treatments, the recommended dose is 800 mg per day, taken as two 200 mg capsules twice daily. For children, the total daily dose should not be more than 800 mg.
Method
Swallow the capsules whole with water. Do not eat anything when you take your capsules. Do not open the capsules. If you or your child cannot swallow a capsule whole, other nilotinib medicines should be used instead of Nilotinib Stada.
Important
The maximum daily dose for adults is 800 mg. For children and adolescents, the total daily dose should not be more than 800 mg.
Possible Side Effects
COMMON
- •Diarrhea
- •Headache
- •Lack of energy
- •Muscle pain
- •Itching, rash
- •Nausea
- •Constipation
- •Vomiting
- •Hair loss
- •Pain in limbs, bone pain, and back pain when stopping Nilotinib Stada treatment
- •Slow growth in children and adolescents
- •Upper respiratory infection, including sore throat and runny or blocked nose, sneezing
- •Low levels of blood cells (red blood cells or platelets) or hemoglobin
- •High lipase levels in blood (related to pancreas function)
- •High bilirubin levels in blood (related to liver function)
- •High ALAT levels (liver enzyme)
- •Pneumonia
- •Abdominal pain, stomach discomfort after eating, gas, swollen or bloated abdomen
- •Bone pain, muscle cramps
- •Pain (such as neck pain)
- •Dry skin, acne, reduced skin sensitivity
- •Weight loss or gain
- •Insomnia, depression, anxiety
- •Night sweats, heavy sweating
- •General feeling of discomfort
- •Nosebleed
- •Signs of gout: painful and swollen joints
- •Difficulty getting or maintaining an erection
- •Flu-like symptoms
- •Sore throat
- •Bronchitis
- •Ear pain, tinnitus (ringing or humming in the ears without an external sound source)
- •Hemorrhoids
- •Heavy menstrual periods
- •Itchy hair follicles
- •Oral or vaginal yeast infection
- •Signs of conjunctivitis: watery eyes with itching, redness, and swelling
- •Eye irritation and redness
- •Signs of hypertension: high blood pressure, headache, dizziness
- •Flushing
- •Signs of peripheral artery disease: discomfort or pain in leg muscles; weakness or cramps due to reduced blood flow; leg or arm ulcers that heal slowly or not at all; noticeable color changes (bluish or pale) or temperature changes (coolness) in the leg, arm, toes or fingers
- •Shortness of breath
- •Mouth sores and gum inflammation (stomatitis)
- •High amylase levels in blood (pancreatic function)
- •High creatinine levels in blood (kidney function)
- •High alkaline phosphatase or creatine kinase levels
- •High ASAT levels (liver enzyme)
- •High gamma-glutamyl transferase levels (liver enzyme)
- •Leukopenia or neutropenia: low white blood cell count
- •Increased platelet or white blood cell count
- •Low magnesium, potassium, sodium, calcium, or phosphate levels in blood
- •High potassium, calcium, or phosphate levels in blood
- •High fat levels in blood (including cholesterol)
- •High uric acid levels in blood
RARE
- •Allergy (hypersensitivity to Nilotinib Stada)
- •Dry mouth
- •Breast pain
- •Pain or discomfort in the side
- •Increased appetite
- •Male breast enlargement
- •Herpes virus infection
- •Muscle and joint stiffness, swollen joints
- •Feeling of body temperature changes (including feeling hot, chills)
- •Taste disturbance
- •Frequent urination
- •Gastric mucosal inflammation: abdominal pain, nausea, vomiting, diarrhea, swollen abdomen
- •Memory loss
- •Skin cysts, thinning or thickening of the skin, thickening of the outermost skin layer, skin discoloration
- •Psoriasis: thickened, red/silver skin patches
- •Increased light sensitivity of the skin
- •Hearing difficulties
- •Arthritis
- •Urinary incontinence
- •Intestinal inflammation (enterocolitis)
- •Anal abscess
- •Swelling of the nipples
- •Restless legs syndrome
- •Sepsis: fever, chest pain, increased heart rate, shortness of breath or rapid breathing
- •Skin infection (subcutaneous abscess)
- •Skin wart
- •Increase in certain types of white blood cells (eosinophils)
- •Lymphopenia: low white blood cell count
- •High parathyroid hormone levels in blood
- •High lactate dehydrogenase levels (an enzyme)
- •Low blood sugar: nausea, sweating, weakness, dizziness, tremors, headache
- •Dehydration
- •Abnormal fat levels in blood
- •Involuntary tremor
- •Difficulty concentrating
- •Unpleasant and abnormal sensations on touch (dysesthesia)
- •Fatigue
- •Numbness or tingling in fingers and toes (peripheral neuropathy)
- •Paralysis of any facial muscle
- •Conjunctival bleeding (reddish spot in the white of the eye due to damaged blood vessels)
- •Bleeding in the eye
- •Eye irritation
- •Heart attack (myocardial infarction): sudden and crushing chest pain, fatigue, irregular heartbeats
- •Heart murmurs: fatigue, chest discomfort, dizziness, chest pain, palpitations
- •Fungal infection of the feet
- •Heart failure: shortness of breath, difficulty breathing when lying down, swollen feet or legs
- •Pain behind the breastbone (pericarditis)
- •Hypertensive crisis: severe headache, dizziness, nausea
- •Intermittent claudication (leg pain and weakness due to walking)
- •Limb artery narrowing: possibly high blood pressure, painful cramps in one or both hips, thighs or calves after physical activity (e.g., walking or climbing stairs), numbness or weakness in the legs
- •Bruising (without injury)
- •Arteriosclerosis (fat accumulation in arteries)
- •Low blood pressure (hypotension): dizziness, lightheadedness or fainting
- •Pulmonary edema: shortness of breath
- •Pleural effusion: fluid accumulation between the tissue layers lining the lungs and chest cavity (if severe, can reduce the heart's pumping ability), chest pain, cough, hiccups, rapid breathing
- •Interstitial lung disease: cough, difficulty breathing, painful breathing
- •Pleurisy-related pain (pleural pain): chest pain
- •Pleurisy: cough, painful breathing
- •Hoarseness
- •Pulmonary hypertension: high blood pressure in the pulmonary arteries
- •Wheezing
- •Tooth sensitivity
- •Gingivitis: bleeding, tender or swollen gums
- •High urea levels in blood (kidney function)
- •Changes in blood protein levels (low globulin levels or presence of paraprotein)
- •High unconjugated bilirubin levels in blood
- •High troponin levels in blood
- •Redness and/or swelling, possibly peeling of palms and soles (hand-foot syndrome)
- •Oral warts
- •Feeling of hardness or stiffness in breasts
- •Thyroid inflammation (thyroiditis)
- •Mood changes or depression
- •Secondary hyperparathyroidism: bone and joint pain, abnormally frequent urination, abdominal pain, weakness, fatigue
- •Cerebral artery narrowing: complete or partial vision loss in both eyes, double vision, vertigo, numbness or tingling, impaired coordination, dizziness or confusion
- •Brain swelling (possibly headache and/or changes in mental state)
- •Optic neuritis: blurred vision or vision loss
- •Heart dysfunction (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
- •Low or high insulin levels
- •Low C-peptide levels (pancreatic function)
- •Sudden death
- •Heart dysfunction (left ventricular dysfunction): shortness of breath, exertional dyspnea, irregular heartbeats, chest discomfort, dizziness, pain, palpitations, abnormally frequent urination, swollen feet, ankles, and abdomen.
Important Warnings
- Do not take Nilotinib Stada if you are allergic to nilotinib or any other ingredient in the medicine.
- Tell your doctor if you have ever had heart or blood vessel problems, such as a heart attack, chest pain, stroke, or blood flow issues in your legs, or if you have risk factors like high blood pressure, diabetes, or high cholesterol.
- Inform your doctor if you have a heart condition, such as a long QT interval (an electrical problem with the heart).
- Let your doctor know if you are taking medicines that lower cholesterol (statins), affect heart function (antiarrhythmics), or affect your liver.
- Notify your doctor if you have low potassium or magnesium levels.
Show 13 more warnings
- Tell your doctor if you have liver or pancreas diseases.
- Inform your doctor if you bruise easily, feel tired, are short of breath, or have repeated infections.
- Tell your doctor if you have had your entire stomach removed (total gastrectomy).
- Inform your doctor if you have ever had or might have a hepatitis B infection, as Nilotinib Stada can reactivate it, which can be fatal.
- Contact your doctor right away if you faint (lose consciousness) or have an irregular heartbeat, as these can be signs of a serious heart condition.
- Immediately contact your doctor if you experience sudden heart palpitations, severe muscle weakness or paralysis symptoms, seizures, or sudden changes in your thinking or awareness, as these could be signs of tumor lysis syndrome.
- Tell your doctor right away if you have chest pain or discomfort, numbness or weakness, difficulty walking or speaking, pain, discoloration, or coldness in any limb, as these can be signs of heart and blood vessel problems.
- Inform your doctor if your feet or hands swell, you have general swelling, or you gain weight very quickly, as these could be signs of severe fluid buildup in your body.
- Do not take Nilotinib Stada with food, as eating can increase the absorption of the medicine and potentially raise its levels in your blood to harmful levels. Do not eat grapefruit or drink grapefruit juice, as this can also increase Nilotinib Stada levels in your blood to a harmful extent.
- Nilotinib Stada is not recommended during pregnancy unless absolutely necessary. Use effective contraception during treatment and for two weeks after stopping. Breastfeeding is not recommended during treatment or for two weeks after the last dose.
- If you experience side effects like dizziness or vision problems that affect your ability to drive or use machines safely, avoid these activities until the effects wear off.
- Nilotinib Stada contains lactose. If your doctor has told you that you have an intolerance to some sugars, discuss this with your doctor before taking this medicine.
- Nilotinib Stada 50 mg and 150 mg capsules contain less than 1 mmol (23 mg) of sodium per dose, so it is considered 'sodium-free'.