Nilotinib STADA

Nilotinib Stada is a medicine containing nilotinib that is used to treat a specific type of blood cancer called chronic myeloid leukemia.

Form
kapseli, kova
Strength
200 mg
Active Ingredient
Nilotinib hydrochloride dihydrate
Manufacturer
STADA Arzneimittel AG

How to Use

Dosage

Your doctor will prescribe the correct dose for you, which is usually 600 mg or 800 mg per day, divided into two doses.

Method

Swallow the capsules whole with water. Do not eat anything when you take the capsules, and do not open them.

Important

Do not exceed a maximum daily dose of 800 mg.

Possible Side Effects

COMMON
  • Loose or watery stools.
  • Pain in your head.
  • Feeling very tired or lacking energy.
  • Aches or pain in your muscles.
  • Itchy skin or red, bumpy skin.
  • Feeling sick to your stomach.
  • Difficulty having bowel movements.
  • Throwing up.
  • Losing hair.
  • Pain in your arms, legs, bones, or back when you stop taking Nilotinib Stada.
  • Children and teenagers may grow more slowly.
  • Cold-like symptoms, like a sore throat, runny or blocked nose, and sneezing.
  • Lower than normal amounts of red blood cells, platelets, or hemoglobin in your blood.
  • High levels of a substance (lipase) in your blood, which can affect your pancreas.
  • High levels of a substance (bilirubin) in your blood, which can affect your liver.
  • High levels of a liver enzyme (ASAT) in your blood.
  • A lung infection.
  • Stomach pain, feeling uncomfortable after eating, gas, or a swollen belly.
  • Bone pain or muscle spasms.
  • Pain, like a stiff neck.
  • Dry skin, pimples, or less feeling in your skin.
  • Losing or gaining weight.
  • Trouble sleeping, feeling sad, or worried.
  • Sweating a lot, especially at night.
  • Feeling generally unwell.
  • Bleeding from your nose.
  • Joint pain and swelling, which can be signs of gout.
  • Trouble getting or keeping an erection.
  • Feeling like you have the flu.
  • Pain in your throat.
  • Inflammation in your airways.
  • Ear pain or ringing/buzzing sounds in your ears.
  • Swollen veins in your rectum.
  • Periods that are heavier than usual.
  • Itchy hair roots.
  • Yeast infection in your mouth or vagina.
  • Pink eye, with watery, itchy, red, and swollen eyes.
  • Irritated or red eyes.
  • High blood pressure, headaches, or dizziness.
  • Red skin.
  • Pain, discomfort, weakness, or cramps in your leg muscles when walking, slow-healing sores on legs or arms, or changes in skin color/temperature in your limbs.
  • Feeling out of breath.
  • Sores in your mouth and swollen gums.
  • High levels of a substance (amylase) in your blood, which can affect your pancreas.
  • High levels of a substance (creatinine) in your blood, which can affect your kidneys.
  • High levels of certain enzymes (alkaline phosphatase or creatine phosphokinase) in your blood.
  • High levels of a liver enzyme (gamma-glutamyl transferase) in your blood.
  • Low numbers of white blood cells in your blood.
  • More platelets or white blood cells than normal in your blood.
  • Low levels of minerals like magnesium, potassium, sodium, calcium, or phosphorus in your blood.
  • High levels of minerals like potassium, calcium, or phosphorus in your blood.
  • High levels of fats, including cholesterol, in your blood.
  • High levels of uric acid in your blood.
  • Sudden, crushing chest pain, feeling tired, or irregular heartbeats (signs of a heart attack).
  • Feeling tired, discomfort in your chest, dizziness, chest pain, or a fluttering heart (signs of a heart murmur).
  • A fungal infection on your feet.
  • Shortness of breath, trouble breathing when lying down, or swollen feet or legs (signs of heart failure).
  • Pain behind your breastbone.
  • Bad headaches, dizziness, or feeling sick to your stomach due to a sudden rise in blood pressure.
  • Leg pain and weakness when you walk.
  • High blood pressure, painful cramps in your hips, thighs, or calves after activity, or numb/weak legs (signs of blocked arteries in your limbs).
  • Bruises that appear without an injury.
  • Fats building up in your arteries.
  • Dizziness, lightheadedness, or fainting due to low blood pressure.
  • Shortness of breath (signs of fluid in your lungs).
  • Fluid building up around your lungs, chest pain, cough, hiccups, or fast breathing (signs of fluid around your lungs).
  • Cough, trouble breathing, or pain when you breathe (signs of a lung disease).
  • Chest pain (signs of inflammation around your lungs).
  • Cough or pain when you breathe (signs of inflammation around your lungs).
  • A raspy voice.
  • High blood pressure in the arteries of your lungs.
  • A whistling sound when you breathe.
  • Sensitive teeth.
  • Bleeding, tender, or swollen gums.
  • High levels of a waste product (urea) in your blood, which can affect your kidneys.
  • Changes in the amount of protein in your blood.
  • High levels of bilirubin in your blood.
  • High levels of troponin in your blood.
RARE
  • An allergic reaction to Nilotinib Stada.
  • Feeling that your mouth is dry.
  • Pain in your breasts.
  • Pain or an uncomfortable feeling in your side.
  • Feeling hungrier than usual.
  • Swelling of the chest area in men.
  • Infection caused by the herpes virus.
  • Stiff muscles or joints, or swollen joints.
  • Feeling hot or cold flashes.
  • Changes in how things taste.
  • Needing to pee often.
  • Stomach pain, feeling sick, throwing up, diarrhea, or a swollen belly, which can be signs of inflammation in your stomach lining.
  • Trouble remembering things.
  • Lumps under the skin (cysts), thinner or thicker skin, or changes in skin color.
  • Thick, red, or silvery patches on your skin (psoriasis).
  • Skin becoming more sensitive to sunlight.
  • Trouble hearing.
  • Swollen and painful joints.
  • Leaking pee by accident.
  • Inflammation in your intestines.
  • A painful lump near your bottom.
  • Swollen nipples.
  • An strong urge to move your legs (or other body parts), often with uncomfortable feelings.
  • Fever, chest pain, fast heart rate, or trouble breathing, which can be signs of a severe infection.
  • A painful lump or infection under your skin.
  • A small, hard growth on your skin.
  • More of a certain type of white blood cell (eosinophils) in your blood.
  • High levels of a hormone (parathyroid hormone) that controls calcium and phosphorus in your blood.
  • High levels of an enzyme (lactate dehydrogenase) in your blood.
  • Feeling sick, sweating, weak, dizzy, shaky, or having a headache due to low blood sugar.
  • Not having enough water in your body.
  • Unusual levels of fats in your blood.
  • Shaking that you can't control.
  • Trouble focusing.
  • Strange or uncomfortable feelings when you touch things.
  • Feeling extremely tired.
  • Numbness or tingling in your fingers and toes.
  • Weakness or inability to move parts of your face.
  • A red spot on the white part of your eye from broken blood vessels.
  • Bleeding in your eye.
  • Redness and/or swelling of palms and soles, possibly with peeling (hand-foot syndrome).
  • Warts in the mouth.
  • Feeling of hardness or stiffness in the breasts.
  • Thyroid inflammation (thyroiditis).
  • Mood changes or depression.
  • Bone and joint pain, abnormally increased urination, abdominal pain, weakness, fatigue (signs of overactive parathyroid gland).
  • Complete or partial vision loss in both eyes, double vision, vertigo, numbness or tingling, impaired coordination, dizziness or confusion (signs of cerebral artery stenosis).
  • Brain swelling (possibly headache and/or changes in mental state).
  • Blurred vision or vision loss (signs of optic neuritis).
  • Fatigue, uncomfortable feeling in the chest, dizziness, pain, palpitations (signs of heart dysfunction with reduced ejection fraction).
  • Low or high insulin levels in blood (hormone regulating blood sugar).
  • Low C-peptide levels in blood (pancreatic function).
  • Sudden death.

Important Warnings

  • If you faint or your heart beats irregularly, tell your doctor immediately.
  • If you experience sudden heart palpitations, severe muscle weakness, paralysis, seizures, or changes in your thinking, tell your doctor immediately.
  • If you have chest pain, numbness, weakness, difficulty walking or speaking, pain or skin color changes in your limbs, tell your doctor immediately.
  • If your legs, hands, or body swell, or if you gain weight rapidly, tell your doctor.