Prescribing Information

Important Information about TASIGNA

TASIGNA (nilotinib) 200-mg capsules is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. 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.

You may lower your chances for having QT prolongation with TASIGNA if you:

• Take TASIGNA on an empty stomach.
  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.

Take TASIGNA:

• At least 2 hours after eating any food, and
• After taking TASIGNA, wait at least 1 hour before eating any food
• Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while 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

TASIGNA is a prescription medication.

TASIGNA comes in 200 mg capsules. Your doctor will prescribe 400 mg of TASIGNA to be taken twice a day for a total daily dose of 800 mg. Each dose should be taken approximately 12 hours apart.

Swallow TASIGNA capsules whole with water.

• Do not open TASIGNA capsules
• Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract. It may affect the levels of TASIGNA in the blood
• If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a missed dose

Before taking 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.

Tell your doctor if:

• You have a heart disorder or are taking medication for the heart
• You have an irregular heartbeat
• You have QT prolongation or a family history of it
• You know that you suffer from low blood levels of electrolytes, such as potassium or magnesium or you have a liver or pancreas disorder
• Also tell your doctor if you are pregnant, breast feeding, or 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.

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

Serious side effects

TASIGNA is sometimes associated with serious side effects, with symptoms that include:

• Irregularity in heartbeat or fainting
• Unexplained bleeding or bruising
• Blood in urine or stool
• Unexplained weakness
• Yellow skin and eyes
• Shortness of breath
• Swelling of hands, ankles, feet, or face
• Sudden stomach area pain with nausea and vomiting

Common side effects

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

• Low blood count
• Rash
• Nausea
• Headache
• Itching
• Tiredness
• Diarrhea
• Constipation

Be sure to tell your doctor or pharmacist if you have any side effects during treatment with TASIGNA.

Tell your doctor if you are pregnant or planning to become pregnant. TASIGNA can harm a fetus (unborn baby).

• Women who can get pregnant must use effective birth control during treatment with TASIGNA

Tell your doctor if you are breast-feeding.

Women should not breast-feed while taking TASIGNA.

If you take too much TASIGNA, call your doctor or poison control center right away.

Your doctor will check your heart, do regular blood tests and take bone marrow samples during treatment with TASIGNA. These are done to check for side effects with TASIGNA and to see how well TASIGNA may be working for you. Your doctor should check your blood to monitor the amount of blood cells (white blood cells, red blood cells, and platelets) during treatment. These should be checked every two weeks for the first two months and then monthly thereafter, or as considered necessary by your doctor.

Your doctor may have you stop TASIGNA for some time or reduce your dose if you have side effects with it. Please see accompanying patient information, including Boxed WARNING, and the TASIGNA Medication Guide you received with your prescription.