• THREE PATIENTS
    TAKING TASIGNA SHARE
    THEIR JOURNEY WITH YOU

    Hear the stories of patients taking TASIGNA® (nilotinib)

    Hear the stories of patients taking TASIGNA® (nilotinib)

    The Ph+ CML Story Series features real Ph+ CML patients taking TASIGNA. The patients were compensated by Novartis for participating in this program.

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  • TASIGNA Dual Offer Card TASIGNA Dual Offer Card

    2 WAYS FOR ELIGIBLE
    PATIENTS TO SAVE

    All patients new to TASIGNA® (nilotinib) may receive a free 3 month trial and all eligible commercially insured patients may pay no more than $10 per month.

    Limitations Apply. See Terms & Conditions.

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  • Ph+ CML

    DO YOU WANT TO BETTER UNDERSTAND Ph+ CML?

    Learn more about Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). View illustrations showing what causes Ph+ CML, gain information about the condition, and get tips on talking to your doctor.

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  • myTasigna

    myTasigna

    EDUCATION AND SUPPORT THROUGHOUT YOUR TREATMENT JOURNEY

    Get ongoing information and tools to help you better manage your condition.

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ABOUT TASIGNA

ABOUT TASIGNA

TASIGNA® (nilotinib) 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)
Tasigna capsules 200mg Tasigna capsules 200mg

TASIGNA is also available as 150mg capsules

TASIGNA is an effective treatment for Ph+ CML patients

TASIGNA is an effective treatment for newly diagnosed adult patients with Ph+ CML in chronic phase.

TASIGNA is an effective treatment option for adult patients with Ph+ CML in chronic or accelerated phase who are either resistant or intolerant to previous treatments that included GLEEVEC.

Virginia, TASIGNA Patient Virginia, TASIGNA Patient

Virginia, TASIGNA Patient

WATCH HER STORY

Virginia is a real patient taking TASIGNA for Ph+ CML and was compensated by Novartis for her participation in the Ph+ CML Story Series.

HOW TASIGNA WORKS

HOW TASIGNA WORKS

Ph+ CML happens when BCR-ABL produces BCR-ABL

1. Ph+ CML happens when an abnormal gene called BCR-ABL produces an abnormal protein, also called BCR-ABL.

BCR-ABL protein sends a signal

2. The BCR-ABL protein sends a signal that creates leukemic cells in the blood and bone marrow.

Tasigna binds BCR-ABL reducing the leukemic cell production

3. During in vitro studies, meaning studies that were conducted in test tubes, TASIGNA was shown to bind to and stablize the inactive formation of the ABL protien. This blocked the signal that leads to the production of leukemic cells.

Tasigna blocks BCR-ABL signal, reducing leukemic cell, allowing healthy blood cells to grow

4. Blocking the signal may reduce the amount of leukemic cells and allow healthy blood cells to grow.

Make sure you take TASIGNA® (nilotinib) exactly as prescribed by your physician.

How is TASIGNA different from GLEEVEC?

TASIGNA was intentionally designed in a laboratory environment to bind to the BCR-ABL gene better than GLEEVEC® (imatinib mesylate).

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® (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)
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Robert, TASIGNA Patient Robert, TASIGNA Patient

Robert, TASIGNA Patient

WATCH HIS STORY

Robert is a real patient taking TASIGNA for Ph+ CML and was compensated by Novartis for his participation in the Ph+ CML Story Series.

HOW EFFECTIVE IS TASIGNA?

HOW EFFECTIVE IS TASIGNA?

In a clinical trial that compared TASIGNA to GLEEVEC® (imatinib mesylate) in newly diagnosed Ph+ CML Patients, TASIGNA was shown to be more effective based on several different criteria:

  • Tasigna vs Gleevec clinical trial blast crisis results

    MAJOR MOLECULAR RESPONSE (MMR) 2

    Twice as many patients who took TASIGNA achieved a major molecular response (MMR) one year into the clinical trial as patients who took GLEEVEC.

      1. Data on file. Study no. CAMN107A2303. Novartis Pharmaceuticals Corp; 2014.
      2. TASIGNA [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2015.
  • Tasigna vs Gleevec clinical trial MMR results

    Based on Kaplan-Meier estimates of time to progression to AP or BC on core treatment (full analysis set) without clonal evolutions

    Tasigna vs Gleevec clinical trial MMR results

    FEWER PATIENTS PROGRESSED TO ACCELERATED OR BLAST CRISIS1

    In a clinical study, for 99% of newly diagnosed patients who took TASIGNA, their Ph+ CML did not progress to the accelerated or blast crisis phase after 5 years, compared to 95% of GLEEVEC patients.

    Based on Kaplan-Meier estimates of time to progression to AP or BC on core treatment (full analysis set) without clonal evolutions

      1. Data on file. Study no. CAMN107A2303. Novartis Pharmaceuticals Corp; 2014.
      2. TASIGNA [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2015.
  • Tasigna vs Gleevec estimated survival rate

    Median overall survival (OS) was not reached in either arm during the ENESTnd study

    Tasigna vs Gleevec estimated survival rate

    HIGHER ESTIMATED RATES OF SURVIVAL1, 2

    The estimated overall rates of survival 5 years after the start of the clinical trial were higher for patients on TASIGNA than GLEEVEC (93.7% vs 91.7%)

    Median overall survival (OS) was not reached in either arm during the ENESTnd study

      1. Data on file. Study no. CAMN107A2303. Novartis Pharmaceuticals Corp; 2014.
      2. TASIGNA [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2015.

You can read more about the studies mentioned above in the TASIGNA Prescribing Information. Please see the TASIGNA Prescribing Information.

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Russ, TASIGNA PatientRuss, TASIGNA Patient

Russ, TASIGNA Patient

WATCH HIS STORY

Russ is a real patient taking TASIGNA for Ph+ CML and was compensated by Novartis for his participation in the Ph+ CML Story Series.

HOW TO TAKE TASIGNA

HOW TO TAKE TASIGNA

TASIGNA comes in 150-mg or 200-mg capsules. Your doctor will prescribe the dosage that’s appropriate for you.

12 hours

Wait 12 hours between doses

When to take TASIGNA

The usual dose is to take 2 capsules in the morning and 2 capsules in the evening. Be sure to follow your doctor’s instructions

Take with Water Take with Water

Take with water

When to Fast When to Fast

Don’t eat two hours before and one hour after your dose

Avoid Grapefruit

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.

Other Medicines and Supplements

Avoid taking other medicines or other supplements with TASIGNA that can also cause QT prolongation. Talk to your doctor if you have questions.

Missed Doses

If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a missed dose.

If you are unable to swallow capsules, the contents of each capsule may be mixed in 1 teaspoon of applesauce or apple purée, and swallowed right away (within 15 minutes).

Unable to Swallow Capsules

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.

Questions?

Additional Instructions for Taking TASIGNA:

TASIGNA is intended to be a long-term treatment. Your doctor will periodically monitor your condition to check that the treatment is having the desired effect. If you have questions about how long to take TASIGNA, talk to your doctor. Do not stop taking TASIGNA or change the amount of TASIGNA that you take unless your doctor tells you to.

Virginia, TASIGNA Patient Virginia, TASIGNA Patient

Virginia, TASIGNA Patient

WATCH HER STORY

Virginia is a real patient taking TASIGNA for Ph+ CML and was compensated by Novartis for her participation in the Ph+ CML Story Series.

UNDERSTANDING SIDE EFFECTS

UNDERSTANDING
SIDE EFFECTS

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

Serious side effects:

TASIGNA may cause serious side effects including:

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

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 of 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
  • 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

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. Do not change your dose of TASIGNA or stop taking it without talking to your doctor first.
Robert, TASIGNA PatientRobert, TASIGNA Patient

Robert, TASIGNA Patient

WATCH HIS STORY

Robert is a real patient taking TASIGNA for Ph+ CML and was compensated by Novartis for his participation in the Ph+ CML Story Series.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) Capsules

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

TASIGNA® (nilotinib) Indications

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)

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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

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 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.