Indication
GLEEVEC® (imatinib mesylate) tablets are indicated for:
Newly diagnosed adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy Adult patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL) Adult patients with myelodysplastic/
Who should NOT take GLEEVEC
Women who are or could be pregnant. Fetal harm can occur when administered to pregnant women; therefore, women should not become pregnant, as well as be advised of the potential risk to the unborn child if GLEEVEC is used during pregnancy. Women who are breast-feeding should not take GLEEVEC because of the potential for serious adverse reactions in nursing infants. Sexually active females should use adequate birth control while taking GLEEVEC.
Be sure to talk to your doctor and/or nurse about these issues before taking GLEEVEC.
Warnings and precautions
Edema (swelling) and severe fluid retention have occurred. Your doctor will weigh you regularly and manage unexpected weight gain by drug interruption and diuretics. Cytopenias (reduction or lack of certain cell elements in blood circulation) such as anemia, have occurred. Your doctor will perform complete blood counts weekly for the first month, biweekly for the second month, and periodically thereafter. In most cases, your doctor will reduce or interrupt your GLEEVEC therapy; in rare cases, your doctor may discontinue treatment. Severe congestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors will be monitored and treated for the condition. Severe liver problems (hepatotoxicity) may occur. Your doctor will check your liver function before beginning treatment and continue to monitor liver function as needed. Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with newly diagnosed PH+ CML and KIT+ GIST. GI tumor sites may be the cause of this bleeding in KIT+ GIST. GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported. In patients with certain conditions associated with high eosinophil levels (eg, HES, MDS/MPD and ASM), beginning Gleevec has been associated with cardiogenic shock/ left ventricle dysfunction Skin reactions, such as fluid filled blisters, have been reported with the use of GLEEVEC. Clinical cases of hypothyroidism have been reported in patients taking levothyroxine replacement during treatment with GLEEVEC. Your doctor should closely monitor your TSH levels. Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use. GLEEVEC can cause fetal harm when administered to a pregnant woman. Women should be aware of the potential harm to the fetus.
Important safety information
The following serious side effects have been reported in patients taking GLEEVEC:
Severe fluid retention, which can cause swelling around the eyes or swelling of the lower legs, lungs, and heart; fatal in rare cases Low levels of certain blood cells Heart failure/cardiogenic shock Liver problems Skin blistering Hemorrhage (abnormal bleeding) Low levels of thyroid hormone
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 (a small hole or tear).
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 (a small hole or tear).
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:
Fluid retention Muscle cramps or painAbdominal painVomitingDiarrheaHemorrhage (abnormal bleeding)NauseaFatigueRash
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 which 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 adverse events have been reported in patients treated with GLEEVEC: compression of the heart due to increased fluid, GI perforation (holes in the stomach or intestine), and sudden lung failure. These events, including some fatalities, may or may not have been drug related.
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