Nilotinib Zentiva

Nilotinib Zentiva is used to treat chronic myeloid leukemia (CML), a type of blood cancer where the body produces too many abnormal white blood cells.

Form
kapseli, kova
Strength
50 mg
Active Ingredient
Nilotinib
Manufacturer
Zentiva k.s.

How to Use

Dosage

For newly diagnosed CML, the usual dose is 600 mg per day (two 150 mg capsules twice a day). If previous treatments haven't worked, the usual dose is 800 mg per day (two 200 mg capsules twice a day).

Method

Swallow the capsules whole with water. Do not open the capsules. Take the capsules twice a day (about 12 hours apart), at least 2 hours after any food, and wait 1 hour before eating again. Do not eat grapefruit or drink grapefruit juice.

Important

The maximum daily dose is 800 mg. For children, the doctor will determine the dose based on weight and height, but the total daily dose should not exceed 800 mg.

Possible Side Effects

COMMON
  • Diarrhea, headache, fatigue.
  • Muscle and joint pain, rash, itching.
  • Nausea, vomiting, constipation, abdominal pain, gas.
  • Hair loss, weight changes.
  • Upper respiratory infections, sore throat, stuffy nose.
  • Anemia (low red blood cells), low platelet count.
  • Insomnia, depression, anxiety.
  • Severe sweating, night sweats.
  • High blood pressure, dizziness.
  • Mouth and gum inflammation, dry skin, acne.
  • Eye irritation, redness, watering.
  • Pain in limbs, bones, or back when stopping treatment.
  • Slow growth in children and adolescents.
RARE
  • Allergic reaction, breast pain, side pain.
  • Dry mouth, increased appetite.
  • Muscle and joint stiffness, joint swelling.
  • Changes in body temperature (hot flashes, chills), taste disorders.
  • Frequent urination, urinary incontinence, bowel inflammation.
  • Memory loss, skin cysts, thinning or thickening of skin, skin discoloration, increased sun sensitivity.
  • Hearing difficulties, tinnitus (ringing in ears).
  • Restless legs syndrome, redness, swelling, or peeling of palms and soles.
  • Blood poisoning (fever, fast heart rate, shortness of breath).
  • Low blood sugar (nausea, sweating, weakness, dizziness, tremors, headache).
  • Difficulty concentrating, numbness or tingling in fingers and toes.
  • Heart attack, heart failure (shortness of breath, swelling), irregular heartbeat.
  • Lung problems (pulmonary edema, fluid in lungs, cough, difficulty breathing).
  • Brain problems (swelling, partial vision loss, double vision, confusion).
  • Sudden death.

Important Warnings

  • Do not use if you are allergic to nilotinib or any other ingredients in this medicine.
  • Tell your doctor if you have ever had heart or circulation problems (like a heart attack, chest pain, stroke, or problems with blood flow to your legs) or risk factors (high blood pressure, diabetes, high cholesterol).
  • Tell your doctor if you have a heart rhythm disorder, such as a long QT interval.
  • Tell your doctor about all medicines you are taking, especially those that lower cholesterol (statins), affect your heart, or affect your liver.
  • Tell your doctor if you have low potassium or magnesium levels in your blood.
Show 12 more warnings
  • Tell your doctor if you have liver or pancreas problems.
  • Tell your doctor if you experience unusual bruising, tiredness, shortness of breath, or frequent infections.
  • Tell your doctor 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 a serious heart condition.
  • Contact your doctor immediately if you experience sudden heart palpitations, severe muscle weakness, paralysis symptoms, seizures, or sudden changes in your thinking.
  • Contact your doctor immediately if you experience chest pain, numbness, weakness, difficulty walking or speaking, or color changes in your limbs.
  • Contact your doctor immediately if your feet or hands swell, you have general swelling, or you gain weight quickly.
  • Not recommended for pregnant or breastfeeding women. Use effective contraception during treatment and for 2 weeks after.
  • Avoid driving or operating machinery if you experience dizziness or vision problems.
  • This medicine contains lactose. Talk to your doctor if you have a sugar intolerance.
  • Do not stop taking this medicine without first talking to your doctor.