Common and Serious Side Effects of TASIGNA

UNDERSTANDING SIDE EFFECTS AND TIPS TO HELP YOU.

TASIGNA® (nilotinib) capsules may cause side effects in some patients. Some of these side effects are serious and some are more common. 

  • Side effects may vary from patient to patient
  • Write down any side effects you are experiencing and share this information with your doctor
  • Work closely with your doctor to best manage side effects. You'll find a few tips that may help you manage side effects below

What is the most important information I should know about TASIGNA?

QTc Prolongation and Sudden Death: TASIGNA can cause QTc prolongation, a possibly life-threatening heart problem. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint, or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QTc prolongation.

 

  • Your doctor should check your heart with a test called an electrocardiogram (ECG)
  • Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your blood
  • TASIGNA can interact with many medicines and supplements. This may increase your chances for serious and life-threatening side effects. Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so
  • Food and grapefruit products increase the amount of TASIGNA in your body. This may increase your chances for serious and life-threatening side effects. Take TASIGNA on an empty stomach
    • Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken
    • Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA

TASIGNA can cause serious side effects that can even lead to death. During treatment with TASIGNA your doctor will do tests to check for side effects. These tests will check your heart, blood cells (white blood cells, red blood cells, and platelets), electrolytes (potassium, magnesium), cholesterol, blood sugar, and pancreas and liver function. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects. You should follow your doctor’s instructions.

TASIGNA may cause serious side effects, including:

  • Low blood cell counts
  • Decreased blood flow to the legs, heart, or brain
  • Pancreas inflammation (pancreatitis)
  • Liver problems
  • Tumor lysis syndrome
  • Bleeding problems
  • Fluid retention
  • Abnormal growth or development in children

 

Common Side Effects in Adults and Children Include:

  • Higher-than-normal level of bilirubin in the blood
  • Headache
  • Increased levels of liver enzymes in the blood
  • Rash
  • Fever
  • Nausea
  • Pain in hands or feet
  • Upper respiratory infections
  • Vomiting
  • Diarrhea
  • Runny or stuffy nose, sneezing, sore throat

Managing potential side effects

Side effects may vary among those taking TASIGNA. It’s important to speak with your doctor about any side effects you may experience.

 

Here are a few things to keep in mind:

  • Don’t keep side effects to yourself: Your doctor can only offer you tips to help you manage side effects if you make your doctor aware of them
  • Talk to your doctor before making any changes: You may read something online about managing side effects, or get a tip from someone else with your condition. Be sure to speak with your doctor before making any changes to your daily routine
  • Keep track of any side effects: You may find it helpful to write down any side effects you have. Be sure to note the date and time you experienced a side effect