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TASIGNA is a prescription medicine used to treat adults who fall into one of two groups. The first is adults with 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) by 1 year.
The second group that TASIGNA is indicated for is adults with 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).
Ph+ CML happens when an abnormal gene called BCR-ABL produces an abnormal protein called BCR-ABL, leading to abnormalities in your body's process for making blood cells. The BCR-ABL protein acts like a switch that keeps your white-blood cell production in the "on" position. Your bone marrow keeps making damaged white blood cells that, over time, crowd out healthy red blood cells and platelets.
TASIGNA may bind to the BCR-ABL protein, which may block the signal that leads to the production of leukemic cells. Blocking the signal may lead to the death of leukemic cells.
Even if test results show that TASIGNA is working, you may still have levels of the BCR-ABL protein in your blood. If you stop taking TASIGNA or change your dose without speaking with your doctor, the abnormal protein could lead to the production of more leukemic cells. This is why it is so important you keep taking TASIGNA exactly as prescribed and not make any changes to your treatment without talking with your doctor.
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