New Indication

About Ph+ CML

Overview of Ph+ CML

In people with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), the body produces too many white blood cells and these cells are often immature or damaged.
Learn more about Ph+ CML

What does intolerance mean?

In rare instances, some people taking treatment for Ph+ CML, such as GLEEVEC® (imatinib mesylate) tablets, have difficulty staying on treatment due to bothersome side effects.
Click here for important GLEEVEC safety information and full Prescribing Information.
Find out more about how intolerance is defined

What does resistance mean?

Researchers have a good understanding of why some people lose their response—sometimes even after years of successful treatment.
Learn more about GLEEVEC resistance

The National Comprehensive Cancer Network (NCCN) recommends your doctor consider another medicine if you don't respond to treatment

  • Failure to achieve a complete hematologic response (CHR) at 3 months
  • Failure to achieve a cytogenetic response (CyR) at 6 months
  • Failure to achieve a partial cytogenetic response (PCyR) at 12 monthsa
  • Failure to achieve a complete cytogenetic response (CCyR) at 18 monthsa
  • Had a hematologic relapse
  • Had a cytogenetic relapse
  • Had a major adverse reaction, or any adverse reaction that has persisted for at least 1 monthb
  • Have not received or been able to tolerate the minimum 400-mg/day dose of GLEEVEC

If you've experienced any of the above and have questions, print this page and, at your next doctor visit, show your doctor this page and ask whether switching to another medicine is an option for you.

  • a Major cytogenetic response (MCyR)=CCyR+PCyR.
  • b The NCCN guidelines do not offer specific direction on defining intolerance. This definition comes from Kantarjian HM et al. Blood. 2007;110(10):3540-3546.
A single open-label multicenter study was conducted to evaluate the efficacy and safety of TASIGNA® in patients with imatinib-resistant or -intolerant Ph+ CML with separate cohorts for chronic- and accelerated-phase disease. The definition of imatinib resistance included failure to achieve a CHR (by 3 months), CyR (by 6 months), or MCyR (by 12 months), or progression of disease after a previous cytogenetic or hematologic response. GLEEVEC intolerance was defined as discontinuation of treatment due to toxicity and lack of a MCyR at time of study entry.

Terms used to describe improvements

Hematologic response

  • Improvement in the number of healthy cells in the blood
  • In a CHR, white blood cell and platelet counts are within the normal range

Cytogenetic response

  • A reduction in the number of cells in the bone marrow that have the Ph chromosome
  • In a PCyR, abnormal cells are greatly reduced but not completely gone
  • In a CCyR, abnormal cells with the Ph chromosome are undetectable

Molecular response

  • The abnormal protein Bcr-Abl is greatly decreased (major molecular response) or undetectable (complete molecular response)

Treating Your Ph+ CML

Working with your healthcare team
and having extra support when you
need it can help.
See more about treating your Ph+ CML

Learn more

Overview of Ph+ CML

What Does Intolerance Mean?

What Does Resistance Mean?

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What is the most important information to know about prescription TASIGNA?
TASIGNA can cause a possible life-threatening heart problem called QT prolongation.

QT prolongation causes an irregular heartbeat, which may lead to sudden death.

Your doctor should check 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

TASIGNA® (nilotinib) Indications

TASIGNA is a prescription medicine used to treat adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The efficacy of TASIGNA is based on major molecular response and cytogenetic response rates. The study is on-going and more data will be needed to determine long-term outcomes.

TASIGNA is also used to treat chronic phase or accelerated phase Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who are no longer benefiting from previous other treatments, including imatinib (GLEEVEC), or have taken other treatments, including imatinib (GLEEVEC) but cannot tolerate them. The efficacy of TASIGNA is based on hematologic response and cytogenetic response rates.

IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib)

What is the most important information to know about prescription TASIGNA?

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

Your doctor should check 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 QT prolongation with TASIGNA if you:

  • Take TASIGNA on an empty stomach
  • DO NOT TAKE TASIGNA WITH FOOD
    • Food can affect the levels of TASIGNA in your body, which can lead to serious side effects
    • Taking TASIGNA on an empty stomach may lower your chances of having a possibly life-threatening heart problem called QT prolongation
    • QT prolongation causes an irregular heartbeat, which may lead to sudden death

Who should not take TASIGNA?

Do not take if you have:

  • Low levels of potassium or magnesium in your blood
  • Long QTc syndrome

Taking TASIGNA:

  • TASIGNA should be taken exactly as instructed by your doctor. Do not change the dose or stop taking TASIGNA unless instructed to by your doctor.
  • Take TASIGNA at least 2 hours after eating any food
  • After taking TASIGNA, wait at least 1 hour before eating any food
  • 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 other supplements with TASIGNA that can also cause QT prolongation
    • Swallow TASIGNA capsules whole with water. If you cannot swallow TASIGNA capsules whole, tell your doctor
  • If you cannot swallow TASIGNA capsules whole:
    • Open the TASIGNA capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple)
      • Do not use more than 1 teaspoon of applesauce
      • Only use applesauce. Do not sprinkle TASIGNA onto other foods
    • Swallow the mixture right away (within 15 minutes)
  • Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract. It may affect the levels of TASIGNA in the blood
  • If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a missed dose

Before taking TASIGNA

Talk to your doctor or pharmacist about all other medication(s) you may be taking, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements, since they may affect how TASIGNA works and increase your chance of serious and life-threatening side effects.

Tell your doctor if:

  • You have a heart disorder or are taking medication for the heart
  • You have an irregular heartbeat
  • You have QT prolongation or a family history of it
  • You have liver problems
  • You know that you suffer from low blood levels of electrolytes, such as potassium, magnesium, or calcium
  • You have a pancreas disorder
  • You have had a surgical procedure involving the removal of the entire stomach (total gastrectomy)

Also tell your doctor if you are pregnant, breast-feeding, or lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA.

Serious side effects

TASIGNA may cause serious side effects including:

  • QT prolongation. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation, a possible life-threatening heart problem
  • Low blood counts. Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include:
    • Unexplained bleeding or bruising
    • Blood in urine or stool
    • Unexplained weakness
    • Shortness of breath
  • Liver damage. Symptoms include yellow skin and eyes
  • Pancreas inflammation (pancreatitis). Symptoms include sudden stomach area pain with nausea and vomiting
  • Bleeding in the brain. Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious
  • 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 doctor may do blood tests to check you for TLS

Call your doctor immediately if you experience any of these symptoms. Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it.

Common side effects

Most patients experience side effects at some time. Some common side effects you may experience include:

  • Low blood count
  • Rash
  • Nausea
  • Fever
  • Stomach (abdominal) pain
  • Headache
  • Itching
  • Muscle and joint pain
  • Tiredness
  • Diarrhea
  • Constipation
  • Back pain
  • Muscle spasms
  • Weakness
  • Hair loss
  • Runny or stuffy nose, sneezing, sore throat
  • Cough

Be sure to tell your doctor or pharmacist if you have any side effects during treatment with TASIGNA. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

It is not known if TASIGNA is safe or effective in children.

Tell your doctor if you are pregnant or planning to become pregnant. TASIGNA may harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment with TASIGNA. Talk to your doctor about the best birth control methods to prevent pregnancy while you are taking TASIGNA.

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breast-feed. You should not do both.

If you take too much TASIGNA, call your doctor or poison control center right away.

Your doctor will check your heart, do regular blood tests, and take bone marrow samples during treatment with TASIGNA. These are done to check for side effects with TASIGNA and to see how well TASIGNA is working for you. Your doctor should check your blood to monitor the amount of blood cells (white blood cells, red blood cells, and platelets) during treatment. These should be checked every 2 weeks for the first 2 months and then monthly thereafter, or as considered necessary by your doctor.

Please see the full prescribing information including the Boxed WARNING, and the TASIGNA Medication Guide.