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Understanding TASIGNA Side Effects

TASIGNA

Common & Serious Side Effects of TASIGNA® (nilotinib)

TASIGNA 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

TASIGNA may cause serious side effects including

IMPORTANT SAFETY INFORMATION for TASIGNA® (nilotinib) Capsules

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

TASIGNA can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death.

Your health care provider should check the electrical activity of your heart with a test called an electrocardiogram (ECG):

  • before starting TASIGNA
  • 7 days after starting TASIGNA
  • with any dose changes
  • regularly during TASIGNA treatment

You may lower your chances for having QTc prolongation with TASIGNA if you:

  • 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. Food and grapefruit products increase the amount of TASIGNA in your body.
  • Avoid taking other medicines or supplements with TASIGNA that can also cause QTc prolongation.
  • TASIGNA can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.
  • Do not take any other medicine while taking TASIGNA unless your health care provider tells you it is okay to do so.
  • If you cannot swallow TASIGNA capsules whole, you may open the TASIGNA capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple). Swallow the mixture right away (within 15 minutes). For more information, see "How should I take TASIGNA?"

Call your health care provider right away if you feel lightheaded, faint, or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QTc prolongation.

 

Low blood cell counts. Low blood cell counts (red blood cells, white blood cells, and platelets) are common with TASIGNA, but can also be severe. Your health care provider will check your blood counts regularly during treatment with TASIGNA. Call your health care provider or get medical help right away if you develop any signs or symptoms of low blood counts including:

  • fever
  • chills or other signs of infection
  • unexplained bleeding or bruising
  • unexplained weakness
  • shortness of breath

Decreased blood flow to the legs, heart, or brain. People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the legs, the heart, or brain.
Get medical help right away if you suddenly develop any of the following symptoms:

  • chest pain or discomfort
  • numbness or weakness
  • problems walking or speaking
  • leg pain
  • your leg feels cold
  • change in the skin color of your leg

Pancreas inflammation (pancreatitis). Tell your health care provider right away if you develop any symptoms of pancreatitis including sudden stomach area pain with nausea and vomiting.

Liver problems. Symptoms include yellow skin and eyes.

Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:

  • kidney failure and the need for dialysis treatment
  • an abnormal heart beat

Your health care provider may do blood tests to check you for TLS.

Bleeding problems. Serious bleeding problems and death have happened during treatment with TASIGNA. Tell your health care provider right away if you develop any signs and symptoms of bleeding during treatment with TASIGNA.

Fluid retention. Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling.

Common side effects

The most common side effects of TASIGNA include:

  • nausea
  • rash
  • headache
  • tiredness
  • itching
  • vomiting
  • diarrhea
  • cough
  • constipation
  • muscle and joint pain
  • runny or stuffy nose, sneezing, sore throat
  • fever
  • night sweats

If you and your health care provider decide that you can stop taking TASIGNA and try treatment free remission (TFR), you may have more muscle and bone (musculoskeletal) symptoms than before you stopped treatment. Symptoms may include:

  • muscle pain
  • arm and leg pain
  • joint pain
  • bone pain
  • spine pain

These are not all of the possible side effects of TASIGNA.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

Please see the full Prescribing Information including Boxed WARNING, and the TASIGNA Medication Guide.