GLEEVEC® Drug Prescription Important Safety Information
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Who Should Not Take GLEEVEC
SAFETY: Important product information IndicationClick here for Full Prescribing Information Important information GLEEVEC® is available only by prescription.
GLEEVEC® (imatinib mesylate) tablets are indicated for:
Newly diagnosed adult and pediatric 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/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements
Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown
Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown
Adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP)
Patients with Kit (CD117)–positive gastrointestinal stromal tumors (GIST) that are cancerous, cannot be surgically removed, and/or have spread to other parts of the body
Adult patients after surgery who have had their Kit (CD117)–positive GISTs completely removed. Approval is based on survival without a return of cancer (recurrence-free survival) with a median follow-up of 14 months. Clinical benefit has not been demonstrated by a long-term effect recurrence-free survival or survival
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 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 healthcare professional about these issues before taking GLEEVEC. Warnings and precautions
GLEEVEC is often associated with edema (swelling) and serious fluid retention. It is important that patients be weighed and monitored regularly for signs and symptoms of serious fluid retention, or unexpected weight gain. Patients experiencing unexpected rapid weight gain should speak to their doctor about appropriate supportive care treatment. Studies have shown that edema (swelling) tended to occur more often among patients who are 65 and older or those taking higher doses of GLEEVEC. If you experience severe fluid retention, your doctor may stop your treatment with GLEEVEC until the fluid retention has been managed
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. If the cytopenia is severe, your doctor may reduce your dose or temporarily stop your treatment with GLEEVEC
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. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of GLEEVEC. Your doctor will check your liver function before beginning treatment and continue to monitor liver function as needed. If you experience severe liver problems, your doctor may stop your treatment with GLEEVEC until the liver problem has been managed
Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with Ph+ CML and KIT+ GIST. GI tumor sites may be the cause of this bleeding
In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell), eg, HES, MDS/MPD, or ASM and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) have been associated with the initiation of GLEEVEC therapy. Speak to your doctor regarding appropriate supportive care or discontinuing GLEEVEC
Skin reactions, such as fluid-filled blisters, have been reported with the use of GLEEVEC
Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement during treatment with GLEEVEC. Your doctor should closely monitor your thyroid hormone 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. Be sure to inform your doctor if you are or think you may be pregnant. You should not breast-feed while taking GLEEVEC
GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported
Growth retardation has been reported in children taking GLEEVEC. The long-term effects of extended treatment with GLEEVEC on growth in children are unknown. Growth retardation may be monitored in children receiving treatment
Cases of tumor lysis syndrome (TLS), which refers to a metabolic and electrolyte disturbance caused by the breakdown of tumor cells, have been reported and can be life-threatening in some cases. The patients at risk of TLS are those that have a higher amount of tumor cells and whose tumors are fast-growing before beginning therapy. Your doctor should monitor you closely and take appropriate precautions
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
Increased pressure in the heart or brain; fatal in rare cases
Low levels of certain blood cells
Heart failure/cardiogenic shock
Liver problems
Hemorrhage (abnormal bleeding)
Skin blistering
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). If you are experiencing any of the above-mentioned side effects, please be sure to speak with your doctor immediately.
Common side effects of GLEEVEC Almost all 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 pain and bone painAbdominal painAnorexia (loss of appetite)VomitingDiarrheaDecreased hemoglobinHemorrhage (abnormal bleeding)NauseaFatigueRash
If you are experiencing any of the above-mentioned side effects, please be sure to speak with your doctor immediately.
The severity of some side effects may be reduced with the help of other medicines and advice from your doctor, while others may require stopping GLEEVEC therapy for a while or changing the dose. However, in some cases, GLEEVEC therapy may need to be discontinued. 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 the approval of GLEEVEC, the following adverse events have been reported in patients treated with GLEEVEC: compression of the heart due to increased fluid, swelling of the brain, 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. 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. 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; metoprolol; ketoconazole; 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. Tylenol (acetaminophen) is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals a division of McNeil PPC, Inc. Coumadin (warfarin sodium) is a registered trademark of Bristol-Myers Squibb Company. Dilantin (phenytoin) is a registered trademark of Parke-Davis, a division of Pfizer Inc.
Click here for Full Prescribing Information.
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