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GLEEVEC® INDICATION:
GLEEVEC® (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Follow up is limited to 5 years. GLEEVEC® is also indicated for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
TASIGNA® INDICATION:
TASIGNA® (nilotinib) 200-mg capsules is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of TASIGNA® is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
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GLEEVEC® Important Safety Information
SAFETY: Important Product Information Important Information GLEEVEC is available only by prescription. Indication GLEEVEC® (imatinib mesylate) tablets are indicated for:
Who should NOT take GLEEVEC
Be sure to talk to your doctor and/or nurse about these issues before taking GLEEVEC. Warnings and precautions
Important safety information The following serious side effects have been reported in patients taking GLEEVEC:
Your doctor will check you closely for any side effects to stop more serious complications from occurring. Patients with heart disease or risk factors for heart failure should also be monitored carefully. GLEEVEC is sometimes associated with stomach or intestinal irritation. GLEEVEC should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including deaths, of stomach or intestinal perforation. Common side effects of GLEEVEC A majority of patients treated with GLEEVEC experience side effects at some time. Most side effects are mild to moderate in severity. Some common side effects you may experience include:
Some mild-to-moderate side effects can be managed with the help of other medicines and advice from your doctor. However, in some cases, your dose of GLEEVEC may be stopped for awhile or may be changed. Take GLEEVEC exactly as prescribed. Do not change your dose or stop taking GLEEVEC unless you are told to do so by your doctor. If you miss a dose, take your dose as soon as possible, unless it is almost time for your next dose. In this case, your missed dose should not be taken. A double dose should not be taken to make up for any missed dose. You should take GLEEVEC with a meal and a large glass of water. Be sure to inform your doctor if you are or think you may be pregnant. You should not breast-feed while taking GLEEVEC. Do not take any other medications without talking to your doctor or pharmacist first, including over-the-counter medications such as Tylenol® (acetaminophen), herbal products (St. John's Wort/hypericum perforatum), Coumadin® (warfarin sodium), rifampin, erythromycin, and Dilantin® (phenytoin). Taking these with GLEEVEC may affect how they work, or affect how GLEEVEC works. You should also tell your doctor if you are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods that may affect how GLEEVEC works. Tell your doctor if you experience side effects during therapy with GLEEVEC, including fever, shortness of breath, blood in your stools, jaundice (yellowing of the skin and/or eyes), sudden weight gain, symptoms of heart failure, or if you have a history of heart disease or risk factors for heart disease. After GLEEVEC's approval, the following side effects have been reported in patients treated with GLEEVEC: compression of the heart due to increased fluid, swelling of the brain, GI perforation, and sudden lung failure. These events, including some fatalities, may or may not have been drug related. Please see complete Prescribing Information. Tylenol (acetaminophen) is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals a division of McNeil PPC, Inc.
TASIGNA® Important Safety Information
TASIGNA® (nilotinib) 200-mg capsules is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of TASIGNA® is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. 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 Your doctor should check your heart with a test called an "ECG":
You may lower your chances for having QT prolongation with TASIGNA® if you:
Food can affect the levels of TASIGNA® in your body, which can lead to serious side effects.Taking TASIGNA® on an empty stomach may lower your chances of having a possibly life-threatening heart problem called QT prolongation. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Take TASIGNA®:
TASIGNA® is a prescription medication. TASIGNA® comes in 200 mg capsules. Your doctor will prescribe 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.
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:
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, with symptoms that 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® can harm a fetus (unborn baby).
Tell your doctor if you are breast-feeding. Women should not breast-feed while taking TASIGNA®. 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 two weeks for the first two 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
What is the most important information I should know about Tasigna®?
TASIGNA® can cause a possible life-threatening heart problem called QT prolongation. QT prolongation causes an irregular heart beat, which may lead to sudden death. Your doctor should check your heart with a test called an "ECG":
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