Treating Your Ph+ CML

Talking to Your Doctor

Next to taking your medication as prescribed, good communication with your healthcare provider may be the most important aspect of your treatment with TASIGNA® 150-mg or 200-mg capsules. The following tips can help your next appointment be productive and informative.

  • Bring questions. Before your appointment, take a moment to make a list of questions you would like to discuss with your physician. It's common to forget what you wanted to ask when you get into the exam room. Bringing a list can help you make sure you don't leave your physician's office with lingering concerns or questions
  • Take notes. Bring pen and paper into your appointment, so you can write down what your physician says. Not only can this help you remember important information, but writing things down can often spur additional questions that may help clarify your physician's instructions
  • Take someone with you. Sometimes it's easier to talk with your doctor when a spouse, friend, or partner is by your side. This person can also act as the note-taker
  • Ask questions. Don't hesitate to ask questions. Your healthcare team is there to help you and wants you to have a good understanding of your condition and treatment. If you feel your physician does not have time to answer questions, speak with the nurse. Nurses are a valuable resource and are there to help
  • Share information. Chances are you are working with several doctors and healthcare professionals for your treatment or other health conditions. Speak with the nurse at each healthcare provider's office to make sure that all your providers are sharing important information with each other. For example, make sure your primary doctor is getting test results from your specialist and vice versa
  • Know your test results. Be sure to discuss your test results with your physician and that you get a clear understanding of what they mean, so you are aware of how you are responding to your treatment
  • Remember your other health needs. Most of your energy right now may be going into treating your Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). But try not to neglect your other health needs. Be sure to have your blood pressure and cholesterol checked periodically and to stay up-to-date on other periodic health exams.

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Treating Your Ph+ CML

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What is the most important information to know about TASIGNA?
TASIGNA can cause a possible life-threatening heart problem called QT prolongation.

QT prolongation causes an irregular heartbeat, which may lead to sudden death.

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

TASIGNA Indications

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 with Ph+ CML in chronic phase (CP). The study is ongoing and further data will be required to determine long-term outcomes
  • Are in chronic phase (CP) or accelerated phase (AP) Ph+ CML and are resistant or intolerant to prior therapy that included imatinib

Important Safety Information

Important Information about TASIGNA® (nilotinib)

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

What is the most important information to know about TASIGNA?

TASIGNA can cause a possible life-threatening heart problem called QT prolongation.
QT prolongation causes an irregular heartbeat, which may lead to sudden death.

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

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

Taking TASIGNA:

  • Take TASIGNA at least 2 hours after eating any food
  • 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 the amount of TASIGNA in your body
  • Avoid taking other medicines or other supplements with TASIGNA that can also cause QT prolongation

Who should not take TASIGNA?
Do not take if you have:

  • Low levels of potassium or magnesium in your blood
  • Long QTc syndrome

TASIGNA is a prescription medication. TASIGNA comes in 150 mg and 200 mg capsules. Your doctor will prescribe 300 mg of TASIGNA to be taken twice a day for a total daily dose of 600 mg or 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. If you cannot swallow TASIGNA capsules whole, tell your doctor.

  • If you cannot swallow TASIGNA capsules whole:
    • Open the TASIGNA capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple).
      • Do not use more than 1 teaspoon of applesauce.
      • Only use applesauce. Do not sprinkle TASIGNA onto other foods.
    • Swallow the mixture right away (within 15 minutes).
  • 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 have liver problems
  • You know that you suffer from low blood levels of electrolytes, such as potassium, magnesium, or calcium
  • You have a pancreas disorder
  • You have had a surgical procedure involving the removal of the entire stomach (total gastrectomy)

Also tell your doctor if you are pregnant, breast-feeding, or lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA.

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, some symptoms of which include:

  • Feeling lightheaded, fainting, or having an irregular heartbeat
  • Unexplained bleeding or bruising
  • Blood in urine or stool
  • Unexplained weakness
  • Yellow skin and eyes
  • Shortness of breath
  • Sudden stomach area pain with nausea and vomiting
  • Sudden headache, changes in your eyesight, not being aware of what is going on around you, and becoming unconscious

Common side effects

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

  • Low blood count
  • Rash
  • Nausea
  • Fever
  • Stomach (abdominal) pain
  • Headache
  • Itching
  • Muscle and joint pain
  • Tiredness
  • Diarrhea
  • Constipation
  • Back pain
  • Muscle spasms
  • Weakness
  • Hair loss
  • Runny or stuffy nose, sneezing, sore throat
  • Cough

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 may harm your unborn baby. If you are able to become pregnant, you 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.

Tell your doctor if you are breast-feeding or plan to breast-feed. 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.

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 is 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 2 weeks for the first 2 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.