Nilotinib Capsules 150mg

Description

TASIGNA (nilotinib 150mg,200mg) capsules is a prescription medicine used to treat: Adults with newly diagnosed Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phaseAdults with Ph+ CML in chronic phase IMPORTANT SAFETY INFORMATION ABOUT TASIGNA (nilotinib) CapsulesQTc Prolongation and Sudden Death: TASIGNA can cause QTc prolongation, a possibly life-threatening heart problem. QTc 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 QTc prolongation.Your doctor should check your heart with a test called an electrocardiogram (ECG)Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your bloodTASIGNA can interact with many medicines and supplements. This may increase your chances 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 soFood and grapefruit products increase the amount of TASIGNA in your body. This may increase your chances for serious and life-threatening side effects. Take TASIGNA on an empty stomachAvoid 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 takenAvoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNATASIGNA can cause serious side effects that can even lead to death. During treatment with TASIGNA your doctor will do tests to check for side effects. These tests will check your heart, blood cells (white blood cells, red blood cells, and platelets), electrolytes (potassium, magnesium), cholesterol, blood sugar, and pancreas and liver function. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects. You should follow your doctor’s instructions. Serious side effects include:Low Blood Counts: Low blood counts are common with TASIGNA but can also be severe. Your doctor will check your blood counts regularly during treatment with TASIGNA. Call your doctor right away if you have symptoms of low blood counts including:Fever, chills, or other signs of infectionUnexplained bleeding or bruisingShortness of breathUnexplained weaknessDecreased 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, heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms:Chest pain or discomfortNumbness or weaknessProblems walking or speakingLeg pain or your leg feels coldChange in the skin color of your legPancreas Inflammation (Pancreatitis): Call your doctor if you have symptoms including sudden stomach area pain with nausea and vomitingLiver 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 doctor, or get medical help right away if you develop any symptoms of liver problems including stomach area (abdominal) pain, yellow skin/eyes, and dark-colored urineTumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. Your doctor may do blood tests to check you for TLS. TLS can cause you to have kidney failure (with the need for dialysis treatment) and/or an abnormal heartbeatBleeding Problems: Serious bleeding problems and death have happened during treatment with TASIGNA. Call your doctor right away if you develop signs and symptoms of bleeding such as uncontrolled bleeding, changes in eyesight, unconsciousness, sudden headache, or sudden confusion about your surroundings