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
- 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
Low blood counts
Low blood counts are common with TASIGNA. Your doctor will check your blood counts every 2 weeks for 2 months then monthly thereafter. Symptoms of low blood counts include:
- Unexplained bleeding or bruising
- Blood in urine or stool
- Unexplained weakness
Symptoms include yellow skin and eyes
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.
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
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 what is going on around you and becoming unconscious
Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling
Decreased blood flow to the leg, heart, or brain
People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the leg, 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
Call your doctor right away if you develop signs and symptoms of bleeding
Common side effects
Most patients experience side effects at some time. Some common side effects you may experience include:
- Low blood count
- Muscle and joint pain
- Runny or stuffy nose, sneezing, sore throat
- Night sweats
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
- Take TASIGNA exactly as your doctor tells you to take it. Do not change your dose or stop taking TASIGNA unless your doctor tells you
- TASIGNA is a long-term treatment
- Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it
If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take TASIGNA. If you take:
- A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take TASIGNA, or about 2 hours after you take TASIGNA
- An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take TASIGNA
Please see the full Prescribing Information including the Boxed WARNING, and the TASIGNA Medication Guide.
TASIGNA is a prescription medicine used to treat adults who have:
- 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)
- Ph+ CML in chronic phase and accelerated phase who are no longer benefiting from, or did not tolerate, other treatment including GLEEVEC® (imatinibmesylate). The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic)