Who should take TASIGNA 150-mg and 200-mg capsules?
TASIGNA is a prescription medicine used to treat a type of leukemia called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults who:

• Are newly diagnosed
• Are no longer benefiting from previous other treatments, including treatment with imatinib (GLEEVEC^®)
• Have taken other treatments, including imatinib (GLEEVEC^®), and cannot tolerate them

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

Click here for important GLEEVEC^® [imatinib mesylate] safety information and full Prescribing Information.
The effectiveness of TASIGNA is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

How does TASIGNA work?
TASIGNA is thought to work similarly to GLEEVEC. GLEEVEC may bind to the Bcr-Abl protein, which may block the signal that causes your body to produce too many damaged white blood cells. However, over time, the Bcr-Abl protein can change or mutate. This can lead to GLEEVEC resistance, meaning that GLEEVEC no longer stops the signal that leads to the overproduction of damaged white blood cells. TASIGNA is thought to bind to some mutations of the Bcr-Abl protein that cause GLEEVEC resistance.

Who should NOT take TASIGNA?

• TASIGNA is not recommended during pregnancy. Tell your doctor if you are pregnant or planning to become pregnant. TASIGNA may harm your unborn baby.
• Women of child-bearing potential 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.
• Women should not breast-feed while taking TASIGNA. 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.
• TASIGNA contains lactose (milk sugar). If you know that you have intolerance to lactose, or if you should avoid products
  containing lactose due to another condition, tell your doctor before taking this medicine
• Before taking TASIGNA, tell your doctor if you: have a heart disorder, are taking medication for the heart; irregular heartbeat; QT prolongation or a family history of it; know that you suffer from low blood levels of electrolytes, such as potassium or magnesium; have a liver disorder; or have pancreatitis or other disorder of the pancreas; or if you are lactose intolerant

Call your doctor right away if you faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation.

Can I take TASIGNA with food?
Avoid food for at least 2 hours before taking TASIGNA and at least 1 hour after.

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.

Are there any foods or beverages I should avoid during TASIGNA therapy?
Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Talk to your doctor about other foods you should avoid when taking TASIGNA. Food and grapefruit products increase blood levels of TASIGNA in your body. Avoid taking other medicines, vitamins, or herbal supplements with TASIGNA that can also cause QT prolongation.

Can I take other medicines with 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.

How should I take TASIGNA?
Always take TASIGNA exactly as your doctor has instructed. You should check with your doctor or pharmacist if you have any questions.

Do NOT take TASIGNA with food. No food should be consumed for at least 2 hours before the dose is taken and no food should be consumed for at least one hour after the dose is taken.

Swallow the capsules whole with water. Do not open the capsules. TASIGNA should be taken twice a day, with each dose taken approximately 12 hours apart. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Talk to your doctor about other foods you should avoid when taking TASIGNA. Food and grapefruit products increase blood levels of TASIGNA in your body. Avoid taking other medicines, vitamins, or herbal supplements with TASIGNA that can also cause QT prolongation.

What are the possible side effects of TASIGNA?

Like all medicines, TASIGNA can cause side effects. In some cases, the side effects can be serious or even life threatening. Your doctor will monitor you on a periodic basis for signs or symptoms of serious side effects. Call your doctor right away if you faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation.

Call your doctor immediately if you experience any of these symptoms.

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

How will I know if TASIGNA is working?
Only your doctor can tell whether TASIGNA is working. You will have periodic tests including blood tests during treatment. These will monitor the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see how TASIGNA is working. Your doctor may recommend other types of tests, including bone marrow tests, to see how you are responding to treatment or to monitor for TASIGNA-related side effects. Please click here for a list of tests your physician may perform.

How long will I need to take 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. If you have any further questions on the use of this product, ask your doctor or pharmacist.

What should I do if I take more TASIGNA than I should?
If you take too much TASIGNA, call your doctor or poison control center right away.

What should I do if I forget to take TASIGNA?
If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a missed dose.

How should I store TASIGNA?
Keep TASIGNA and all medicines out of the reach of children. Store TASIGNA at room temperature: 59° to 86°F (15° to 30°C). Do not use TASIGNA after the expiration date, which is stated on the carton after EXP. The expiration date refers to the last day of that month.

What does TASIGNA look like?
TASIGNA comes in red (150 mg) and pale yellow (200 mg) capsules containing nilotinib. TASIGNA comes in special packages that will help you remember to take 2 capsules of TASIGNA twice a day.