TASIGNA is a prescription medicine used to treat a type of leukemia called Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who:
If you are being treated with GLEEVEC (imatinib mesylate) tablets or TASIGNA (nilotinib) 150-mg or 200-mg capsules, you may now qualify to take part in a new support program from Novartis Oncology called My CML CircleTM.
FDA-approved for over 2 years and more than 1700 patients treated2
Do NOT take TASIGNA with food. See these and other important instruction for taking TASIGNA.
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:
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):
You may lower your chances for having QT prolongation with TASIGNA if you:
Taking TASIGNA:
Who should not take TASIGNA?
Do not take if you have:
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.
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:
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:
Common side effects
Most patients experience side effects at some time. Some common side effects you may experience include:
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.