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Resources for Patients With KIT+ GISTMy GIST Circle: Patient Support and Copay
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American Cancer Society®
National Home Office 1599 Clifton Road NE Atlanta, GA 30329 Telephone: 1-800-ACS-2345 Website: http://www.cancer.org Cancer Care®
275 7th Avenue New York, NY 10001 Telephone: 1-800-813-HOPE Website: http://www.cancercare.org GIST Support International
12 Bomaca Drive Doylestown, PA 18901 Telephone: 215-340-9374 www.gistsupport.org GIST Cancer Research Fund
55 Sawmill Rd. New City, NY 10956 Telephone: 1-845-634-6060, 1-845-634-1174 www.gistinfo.org The Life Raft Group
40 Galesi Drive Wayne, NJ 07470 Telephone: 1-973-837-9092 Fax: 1-973-837-9095 Website: http://www.liferaftgroup.org The National Cancer Institute's Cancer Information Service
31 Center Drive, MSC 2580 Bethesda, MD 20892-2580 Telephone: 1-800-4-CANCER Those with TTY equipment may call 1-800-332-8615 Fax: 1-800-624-2511 Website: http://www.cancer.gov/cis http://cis.nci.nih.gov National Comprehensive Cancer Network® Patient Information and Referral Service
Telephone: 1-888-909-NCCN Fax: 1-215-728-3877 Website: http://www.nccn.org National Organization for Rare Disorders
P.O. Box 1968 Danbury, CT 06813-1968 Telephone: 1-800-999-6673 or 1-203-746-6518 Fax: 1-203-746-6481 Website: http://www.rarediseases.org Patient Advocate Foundation
700 Thimble Shoals Blvd., Suite 200 Newport News, VA 23606 Telephone: 1-800-532-5274 Fax: 1-757-873-8999 Website: http://www.patientadvocate.org People Living with Cancer
American Society of Clinical Oncology 1900 Duke Street, Suite 200 Alexandria, VA 22314 Telephone: 703-519-2927 or 888-651-3038 Fax: 703-299-1014 www.plwc.org Please see the Important Safety Information and full Prescribing Information. |
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SAFETY: Important Product Information
Important information GLEEVEC is available only by prescription.
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/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 unknown mutational status
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 cannot be surgically removed, and/or have spread to other parts of the body
Adult patients post-surgery who have had their GISTs completely removed
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). 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. Please see the full Prescribing Information. 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. |
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There are 2 options for the treatment of Ph+ chronic myeloid leukemia (CML). Click on GLEEVEC.com to continue to learn about GLEEVEC® or click the box below to learn more about a second-line option.
