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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

TASIGNA Co-Pay Assistance

Monthly co-pay assistance with the Universal Co-Pay Card.*

Patients may be eligible for immediate co-pay savings on their next prescription.

  • Commercially insured patients may pay no more than $10 per month
  • Annual maximum of $15,000 paid by Novartis per calendar year

To find out if you are eligible, and to obtain your co-pay card, please call 1-877-577-7756 or visit www.copay.novartisoncology.com.

* Limitations apply. See program terms and conditions on the back. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice.

See if you're eligible
TASIGNA® (nilotinib) co-pay card

Universal Co-Pay Card Program Terms & Conditions

Terms and Conditions: Valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program. Offer not valid for cash-paying patients, where product is not covered by patient’s commercial insurance, or where plan reimburses you for entire cost of your prescription drug. Offer is not valid where prohibited by law. Valid only in the United States and Puerto Rico. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. This card is the property of Novartis Pharmaceuticals Corporation and must be returned upon request. Novartis reserves the right to rescind, revoke, or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt, of program rewards, if necessary, to any commercial insurer.

 

Patient Instructions: To find out if you are eligible, and to obtain your copay card, please call 1-877-577-7756 or visit www.copay.novartisoncology.com. Then, present your co-pay card and your insurance card along with a valid prescription at any participating pharmacy or through mail order. Patients with commercial insurance are responsible for up to $10 for a 30-day supply and Novartis pays up to $15,000 per calendar year. If patient reaches the maximum annual cap per calendar year of $15,000, patient will be responsible for the difference. Patient questions should be directed to: 1-877-577-7756.

3 Months FREE Trial Voucher

3 Months FREE, Right From the Start.

Patients who are new to TASIGNA® (nilotinib) can receive a free 3 month trial of TASIGNA capsules, limitations apply.

Click here to Print your 3 month FREE card
TASIGNA® (nilotinib) co-pay card

3 Months FREE Trial Voucher Terms & Conditions

No purchase required. This free trial is not health insurance. Void where prohibited by law. Product dispensed pursuant to terms and conditions of the voucher. Claim shall not be submitted to any public or private third-party payer of any federal or state healthcare program for reimbursement. Valid only in the US and Puerto Rico. Offer not valid if reproduced or submitted to any other payer. Prescriber ID# required on prescription. It is illegal for any person to sell, purchase or trade, or offer to sell, purchase or trade, or to counterfeit this voucher. Pharmacist Instructions: This voucher must accompany a valid prescription. No substitutions permitted. Please dispense at no cost to the patient. For reimbursement, please submit to Preferred Network. Do not submit to any other payer, public or private. The information printed above should be used when submitting for reimbursement. For questions, please call the Help Desk at 1-800-433-4893. This voucher is the property of Novartis and PSKW and must be returned upon request. Both parties reserve the right to rescind, revoke, or amend this program without notice.

Patient Assistance Now Oncology (PANO)


Novartis Oncology is committed to helping patients who are living with cancer receive the medicines they need. Patient Assistance Now Oncology (PANO) offers tools and support designed specifically to help make that process easier. Here are some ways we can help:

  • Offer support with insurance verification to help patients understand their financial responsibilities
  • Assist with understanding insurance plan changes when patients’ coverage changes
  • Help patients find pharmacies covered by their plans to receive medication based on their plans’ guidelines
  • Provide Medicare education
  • Provide information about other financial assistance

 

Call 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making access to therapy as simple and convenient as possible; or visit: www.OncologyAccessNow.com/patient

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.