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Frequently Asked Questions About TASIGNA
Talking points that may be helpful to you
Ph+ CML is a cancer of the blood and bone marrow.
There are 3 types of cells in the blood: white blood cells, red blood cells, and platelets. Leukemia [loo-key-mee-ah] is a disease that makes your white blood cells grow abnormally and out of control. As leukemia spreads, diseased cells outnumber and take over the healthy ones. This can make you feel very sick.
Over time, leukemia cells can spread to the rest of your blood and other organs. When this happens, other cells in your body may stop working the way they should.
A main goal of treating Ph+ CML is to reduce the number of leukemia cells in your body. Doctors use medicine to lower the amount of leukemia cells in your blood.
It’s important to take an active role in your care. You can do this by taking your medicine the way your doctor tells you to. You should also get regular tests to check how the medicine is working.
TASIGNA® (nilotinib) capsules is a prescription medicine used to treat:
- Adults with newly diagnosed Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
- Adults with Ph+ CML in chronic phase and accelerated phase who no longer benefit from, or did not tolerate, other treatment, including GLEEVEC®(imatinib)
- Children (ages 1 year and older) with newly diagnosed Ph+ CML in chronic phase
- Children (ages 1 year and older) with chronic phase Ph+ CML or accelerated phase Ph+ CML who:
- are no longer benefiting from treatment with a tyrosine kinase inhibitor medicine, or
- have taken another tyrosine kinase inhibitor medicine and cannot tolerate it
It is not known if TASIGNA is safe and effective in children younger than 1 year of age with newly diagnosed, resistant, or intolerant Ph+ CML in chronic phase.
The long-term effects of treating children with TASIGNA for a long period of time are not known.
TASIGNA® (nilotinib) capsules can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death.
Your healthcare provider should check the electrical activity of 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 QTc prolongation with TASIGNA if you:
- 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 during treatment with TASIGNA. Food and grapefruit products increase the amount of TASIGNA in your body.
- Avoid taking other medicines or supplements with TASIGNA that can also cause QTc prolongation.
- TASIGNA can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.
- Do not take any other medicine during treatment with TASIGNA unless your healthcare provider tells you it is okay to do so.
- If you cannot swallow TASIGNA capsules whole, you may open the TASIGNA capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple). Swallow the mixture right away (within 15 minutes).
Call your healthcare provider right away if you feel lightheaded, faint, or have an irregular heartbeat during treatment with TASIGNA. These can be symptoms of QTc prolongation.
TASIGNA® (nilotinib) capsules has 10 years of clinical trial data in adults newly diagnosed with Ph+ CML-CP. Learn more about clinical results
If your current medicine for Ph+ CML does not work for you, stops working for you, or you can no longer tolerate its side effects, your doctor may decide it’s time for you to switch to TASIGNA® (nilotinib) capsules. Learn more
Ph+ CML happens when an abnormal gene called BCR-ABL1 produces an abnormal protein called BCR-ABL. The BCR-ABL protein sends a signal that creates leukemic cells in the blood and bone marrow.
During in vitro studies, meaning studies that were conducted in test tubes, TASIGNA® (nilotinib) capsules was shown to bind to and stabilize the inactive formation of the BCR-ABL protein.
The connection between TASIGNA in vitro data and its effectiveness has not been established.
PCR testing is an accurate way for doctors to measure how much BCR-ABL1 is in your body. PCR blood testing can find very small amounts of BCR-ABL1 that other tests cannot find.
PCR is a simple blood test, rather than a bone marrow test. However, doctors still must do bone marrow testing to diagnose Ph+ CML.
TASIGNA® (nilotinib) capsules may cause side effects. 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 TASIGNA side effects:
What is the most important information I should know about TASIGNA?
TASIGNA can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death.
Your health care provider should check the electrical activity of your heart with a test called an electrocardiogram (ECG):
You may lower your chances for having QTc prolongation with TASIGNA if you:
Call your health care provider right away if you feel lightheaded, faint, or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QTc prolongation.
TASIGNA may cause serious side effects including:
- Low blood cell counts. Low blood cell counts (red blood cells, white blood cells, and platelets) are common with TASIGNA, but can also be severe. Your health care provider will check your blood counts regularly during treatment with TASIGNA. Call your health care provider or get medical help right away if you develop any signs or symptoms of low blood counts including:
- chills or other signs of infection
- unexplained bleeding or bruising
- unexplained weakness
- shortness of breath
- Decreased blood flow to the legs, heart, or brain. People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the legs, 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
- Pancreas inflammation (pancreatitis). Tell your health care provider right away if you develop any symptoms of pancreatitis including sudden stomach area pain with nausea and vomiting.
- Liver problems. TASIGNA can increase your risk of liver problems. People who have had liver problems in the past may be at risk for getting liver problems with TASIGNA. Call your health care provider or get medical help right away if you develop any symptoms of liver problems including:
- stomach area (abdominal) pain
- yellow skin and eyes
- dark-colored urine
- 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 heartbeat
- Bleeding problems. Serious bleeding problems and death have happened during treatment with TASIGNA. Tell your health care provider right away if you develop any signs and symptoms of bleeding during treatment with TASIGNA.
- Fluid retention. Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling.
- Abnormal growth or development in children. Effects on growth and development have happened in children with chronic phase Ph+ CML during treatment with TASIGNA. Some children and adolescents may have slower than normal growth during treatment with TASIGNA.
The most common side effects of TASIGNA include:
- muscle and joint pain
- runny or stuffy nose, sneezing, sore throat
- night sweats
Side effects in adults attempting treatment-free remission:
If you and your health care provider decide that you can stop taking TASIGNA and try treatment-free remission (TFR), you may have more muscle and bone (musculoskeletal) symptoms than before you stopped treatment. Symptoms may include:
- muscle pain
- arm and leg pain
- joint pain
- bone pain
- spine pain
Tell your health care provider if you or your child have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
After taking TASIGNA for at least 3 years, your doctor may determine if you meet certain criteria to be eligible to try stopping treatment with TASIGNA. Your doctor may refer to this as treatment-free remission (TFR). If your doctor determines you may attempt TFR, you can expect an increase in the frequency of monitoring. Learn more about TFR.