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Glossary

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

Accelerated phase

A phase of Ph+ CML progression, when the number of immature blood cells (blast cells) is increased.

 

BCR-ABL1

The BCR-ABL1 gene is formed when 2 specific chromosomes combine. The gene then creates the BCR-ABL1 protein—the underlying cause of Ph+ CML.

 

Blast cell

An immature blood cell.

 

Blast crisis

The final phase of Ph+ CML progression, which has the highest number of immature blood cells (blast cells) in the blood and bone marrow.

 

Bone marrow

The soft, spongy inner part of bones where blood cells are made.

 

Chromosome

Long strands that contain coded instructions in cells for making and controlling cells.

 

Chronic Myeloid Leukemia (CML)

A type of cancer that starts in the bone marrow, causing too many damaged white blood cells to form.

 

Chronic phase

The first phase of Ph+ CML progression when the number of white blood cells is higher than normal but may not cause symptoms.

 

Complete cytogenetic response

No Ph+ chromosomes are found in the bone marrow sample cytogenetic.

 

Complete hematologic response

When white blood cells, platelets, and red blood cell counts have returned to a normal range.

 

Cytogenetic testing

Tests done on bone marrow cells or white blood cells to see if they contain the Philadelphia chromosome.

 

Genetic material

The basic unit of heredity passed from parent to child. Genes are made of DNA and carry instructions for making proteins.

 

Hematologic testing

A simple blood test to measure levels of white blood cells, red blood cells, and platelets.

 

Intolerance

When a patient cannot continue taking a medication because of the side effects they are experiencing.

 

Leukemic cells

Diseased white blood cell that grows abnormally.

 

1-log reduction

The levels of leukemia cells are 10 times lower than the standardized baseline of newly diagnosed patients.

 

2-log reduction

The levels of leukemia cells are 100 times lower than the standardized baseline of newly diagnosed patients.

 

3-log reduction

The levels of leukemia cells are 1000 times lower than the standardized baseline of newly diagnosed patients.

 

Major molecular response (MMR)

When the amount of BCR-ABL1 found in the bone marrow sample or blood sample through an IS-PCR test is very low.

 

Milestones

An optimal response or improvement reached by a certain period of time after starting treatment.

 

Molecular testing

The use of PCR (polymerase chain reaction) to find the number of cells expressing BCR-ABL1 in either blood or bone marrow.

 

PCR (polymerase chain reaction) or IS-PCR

A very sensitive test that counts the number of cells containing the BCR-ABL1 gene (which is located on the Philadelphia chromosome). It can be done on either blood or bone marrow cells and can detect a single abnormal cell within a sample of 1 million cells. IS stands for International Scale. It is a standardized scale for measuring and reporting results of PCR testing.

 

Philadelphia chromosome (Ph)

An abnormal chromosome that is responsible for the constant production of abnormal white blood cells (myeloid cells) present in Ph+ CML. The Philadelphia chromosome indicates that CML is present in the body.

 

Platelet

A type of blood cell that helps blood to clot.

 

Protein

An essential component of all living cells that is made up of amino acids.

 

Red blood cell

Type of blood cell that carries oxygen to other cells in the body.

 

Resistance

When a medical condition does not respond to treatment, or stops responding to treatment.

 

White blood cells

A type of blood cell that fights infection.

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.