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Monitoring Treatment

TASIGNA

Important Safety Information, including Boxed WARNING:

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

TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT 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 QT prolongation.

Your doctor should check your heart with a test called an electrocardiogram (ECG):

    • Before starting TASIGNA
    • days after starting TASIGNA
    • With any dose changes
    • Regularly during TASIGNA treatment
  • 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 chance 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 chance 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

Low blood counts

Low blood counts are common with TASIGNA. Your doctor will check your blood counts every 2 weeks for 2 months then monthly thereafter. Symptoms of low blood counts include:

  • Unexplained bleeding or bruising
  • Blood in urine or stool
  • Unexplained weakness

Liver damage

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 doctor may do blood tests to check you for TLS.

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

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 what is going on around you and becoming unconscious

Fluid Retention

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

Decreased blood flow to the leg, heart, or brain

People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the leg, 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

Bleeding

Call your doctor right away if you develop signs and symptoms of bleeding

Common side effects

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

  • Low blood count
  • Nausea
  • Rash
  • Headache
  • Tiredness
  • Itching
  • Vomiting
  • Diarrhea
  • Cough
  • Constipation
  • Muscle and joint pain
  • Runny or stuffy nose, sneezing, sore throat
  • Fever
  • Night sweats

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist.

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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

  • Take TASIGNA exactly as your doctor tells you to take it. Do not change your dose or stop taking TASIGNA unless your doctor tells you
  • TASIGNA is a long-term treatment
  • 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

If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take TASIGNA. If you take:

  • A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take TASIGNA, or about 2 hours after you take TASIGNA
  • An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take TASIGNA

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

Approved Use:

TASIGNA is a prescription medicine used to treat adults who have:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular)
  • Ph+ CML in chronic phase and accelerated phase who are no longer benefiting from, or did not tolerate, other treatment including GLEEVEC® (imatinibmesylate). The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic)
Important Safety Information, including Boxed WARNING:

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

TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, w

... See More
Approved Uses:

TASIGNA is a prescription medicine used to treat adults who have:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment
... See More

Periodic Ph+ CML testing is an important part of treatment

Your doctor may recommend Ph+ CML testing every 3 months to help manage your disease, see if you’re reaching your treatment milestones, and decide if changes to your therapy are needed.

 

Hematologic Tests

Cytogenetic Tests

Molecular Tests

This is a simple blood test that counts the number of white blood cells, red blood cells, and platelets in your blood.

 

If your blood cell counts have returned to within the normal range, you have achieved what is called a complete hematologic response (CHR).

In cytogenetic testing, laboratory technicians look at samples of your bone marrow or blood under a microscope and count the number of cells that contain the Ph (Philadelphia) chromosome.

 

If no cells with the Ph chromosome are found, it is called a complete cytogenetic response (CCyR).

A PCR (polymerase chain reaction) test requires a sample of blood or bone marrow. It is the most sensitive kind of test available for monitoring response to Ph+ CML treatment. A PCR test can find 1 leukemic cell in at least 100,000 normal cells. If the lab results are standardized to the international scale (IS), you may sometimes see this test referred to as IS-PCR.


A major molecular response (MMR) means that the amount of BCR-ABL1 found in the bone marrow sample or blood sample is low. PCR testing can determine if you’ve achieved an MMR.

The goal of your treatment is to lower the number of leukemia cells in your body at specific time points.

Your treatment milestones

Throughout your treatment, the amount of leukemic cells in your body may drop by levels of 10. This is called a log reduction. Periodic testing will let you and your doctor know whether you are reaching these milestones in the recommended timeframe.

 

When a patient does not respond to treatment with GLEEVEC® (imatinib mesylate), or loses their response over time, the patient may be experiencing drug resistance.

For example, some Ph+ CML patients who take GLEEVEC® (imatinib mesylate) to treat their Ph+ CML experience drug resistance. Over time, the BCR-ABL1 protein, the signal that tells your body to produce too many white blood (leukemic) cells, can change or mutate. When this happens, GLEEVEC can stop working to block the creation of leukemic cells.

 

Periodic testing will determine if you are reaching your treatment goals. If you stop responding to treatment, you may be resistant to GLEEVEC.

TASIGNA may be appropriate for patients resistant to GLEEVEC

If it’s confirmed that you’re resistant to GLEEVEC, your doctor may recommend switching therapy. Your doctor will determine if TASIGNA is right for you.

 

Demonstrated response for patients changing to TASIGNA

In a clinical trial of patients who had taken GLEEVEC® (imatinib mesylate) before changing to TASIGNA, TASIGNA was shown to be effective:

Major Cytogenetic Response (MCyR)
51% of Ph+ CML patients in chronic phase achieved major cytogenetic response (MCyR). This means 0%-35% of the cells in the bone marrow test positive for the Philadelphia chromosome.

Major Cytogenetic Response (MCyR)


Hematologic response (HR)

Almost 40% of patients in accelerated phase achieved hematologic response (HR).

 Hematologic response (HR)


Time to Achieve Treatment Milestones

In patients in chronic phase taking TASIGNA, the median time to MCyR was 2.8 months (range 1-28 months), and in patients in accelerated phase taking TASIGNA, the median time to hematologic response was 1 month (range 1-14 months).

 Time to Achieve Treatment Milestones

What does drug intolerance mean?

In rare cases, certain side effects may make it difficult for patients to stay on their Ph+ CML medication. Patients who can no longer stay on treatment because of side effects are said to have drug intolerance.

 

  • Some side effects can go away with time, can be managed with help from your doctor, or can be tolerated
  • Some side effects may be damaging to your health or may be so bothersome they keep you from taking your treatment as prescribed
  • It’s very important that you talk to your doctor or nurse about any side effects you may be experiencing while taking TASIGNA or another Ph+ CML treatment.
    Do not change your dose of TASIGNA or stop taking it without talking to your doctor first.

How is TASIGNA different from GLEEVEC?

TASIGNA was intentionally designed in a laboratory environment to bind to the BCR-ABL1 protein better than GLEEVEC. The connection between TASIGNA in vitro data and its effectiveness has not been established.

 

After 5 years in a clinical trial, 99% of patients taking TASIGNA and 95% of patients treated with GLEEVEC did not progress to accelerated phase or blast crisis phase.*

Twice as many newly diagnosed patients who took TASIGNA achieved a major molecular response (MMR) at one year (44%) as patients who took GLEEVEC (22%).

TASIGNA may work for some patients who are no longer benefiting from other Ph+ CML therapies, including GLEEVEC.

 

*Based on estimated time to progression to AP or BC for patients on core treatment during the pivotal trial.

 

TASIGNA is a prescription medicine used to treat adults who have:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular)

  • Ph+ CML in chronic phase and accelerated phase who are no longer benefitting from, or did not tolerate, other treatment including GLEEVEC. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic)

IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) Capsules

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

TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT 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 QT prolongation.

  •  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
  • 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 chance 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 chance 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® (nilotinib) Indications (Approved Uses)

TASIGNA is a prescription medicine used to treat adults who have:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular)
  • Ph+ CML in chronic phase and accelerated phase who are no longer benefiting from, or did not tolerate, other treatment including GLEEVEC® (imatinib mesylate). The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic)

ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) Capsules

Before taking TASIGNA, tell your doctor about all of your medical conditions, including if you:

  • Have a heart disorder or are taking medication for the heart
  • Have had a stroke or other problems due to decreased blood flow to the brain
  • Have problems with decreased blood flow to your legs
  • Have an irregular heartbeat
  • Have QT prolongation or a family history of it
  • Have liver problems
  • Have had a pancreas disorder known as pancreatitis
  • Know that you suffer from low blood levels of electrolytes, such as potassium or magnesium
  • Have had a surgical procedure involving the removal of the entire stomach (total gastrectomy)
  • Are lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA
  • Have bleeding problems
  • Are pregnant or plan to become pregnant. TASIGNA may harm your unborn baby. Women should not become pregnant while taking TASIGNA. Talk to your health care provider right away if you are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed? It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breastfeed. You should not do both

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

TASIGNA may cause serious side effects, including:

  • 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
  • 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
  • Decreased blood flow to the leg, heart, or brain: People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the leg, 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
  • 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

  • Bleeding: Call your doctor right away if you develop signs and symptoms of bleeding
  • 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

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

  • Low blood count
  • Nausea
  • Rash
  • Headache
  • Tiredness
  • Itching
  • Vomiting
  • Diarrhea
  • Cough
  • Constipation
  • Muscle and joint pain
  • Runny or stuffy nose, sneezing, sore throat
  • Fever
  • Night sweats

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist.

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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

  • Take TASIGNA exactly as your doctor tells you to take it. Do not change your dose or stop taking TASIGNA unless your doctor tells you
  • TASIGNA is a long-term treatment
  • 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

If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take TASIGNA. If you take:

  • A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take TASIGNA, or about 2 hours after you take TASIGNA
  • An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take TASIGNA

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