Kit+ Gastrointestinal Stromal Tumors

Reaching Treatment Milestones



Goals of treatment with GLEEVEC®:
Shrink existing tumors Slow down the spread of tumors Help stop tumors from recurring

To see whether or not you are responding to treatment, your doctor will do several tests at different times. These tests help to measure your body's response to GLEEVEC®.

As your treatment continues, you will come to know these tests. Your doctor will use these tests to check the size of your tumors and to see if your tumors are responding to treatment. The tests will probably be done every 3 to 6 months to keep track of your treatment results. Get as informed as you can. Be sure to talk to your health care team about anything you do not understand.

Test Purpose
1. Computed tomography (CT) scan This scan helps your doctor measure the size and number of your tumors. It may be done in combination with an intravenous (IV) dye and an oral liquid to help the doctor see your GI tract better.
2. Magnetic resonance imaging (MRI) scan An MRI uses radio waves and large magnets to create images of your body. MRIs are often used to see if tumors have come back or spread to other parts of your body.
3. Positron emission tomography (PET) scan A PET scan shows whether tumor cells are "alive" or "dead." You may be injected with a nonharmful dye to help living tumor cells show up clearly.
4. X-rays X-rays use small amounts of radiation to take pictures of parts of the body.

Regular checkups are important
While you are on GLEEVEC®,  your doctor will also do tests at your regular checkups to see how your treatment is affecting you. These tests are done to check whether you are having any of the side effects that can occur with GLEEVEC® and to see if your dose needs to be changed. Set aside some extra time at your next appointment to talk to your health care team about these tests and to ask any questions you may have.

These tests may include the following:
Test Purpose
Physical exam To check your overall health and see how you are dealing with any side effects you may be experiencing. Your doctor will weigh you regularly and watch for signs of fluid retention. Unexpected, rapid weight gain may be a sign of serious fluid retention
Kidney and liver function tests To see how your kidney and liver are working. In some cases your doctor might need to lower or stop your dose of GLEEVEC for a short time. In rare cases, your doctor may permanently discontinue treatment.
Blood monitoring To check your blood cell levels. If your blood cell levels drop below normal, this may cause complications. In particular, your red blood cell count will be carefully watched to make sure there are no signs of anemia (a low level of red blood cells). Anemia may be due either to GLEEVEC®  therapy or your condition.

The uncomfortable digestive tract symptoms of Kit+ GIST sometimes make it difficult for people with Kit+ GIST to get all of the nutrients they need. When you do not have enough nutrients like iron, folate, and vitamin B12, anemia can be a problem.

GLEEVEC®  can also cause a drop in the level of your white blood cells and platelets (cells that clot your blood) to below normal.

 

Most patients will experience side effects at some time. Your doctor will probably be able to help you address them without adjusting your dose. In some cases, your doctor might need to lower or stop your dose of GLEEVEC® for a short time. In rare cases, your doctor may permanently discontinue treatment.

 

Importance of Taking GLEEVEC® Properly
Each person's response to GLEEVEC may vary, so it's important for you to allow enough time for GLEEVEC to work. Remember to take GLEEVEC regularly and as directed by your doctor. Read tips to help you stay on track with your treatment.

If you are responding to GLEEVEC and stop taking GLEEVEC or take less than your doctor has prescribed, the signal may no longer be blocked. Then, the number of abnormal cells could start growing again.

Please see the Important Safety Information and full Prescribing Information.
 

Join the Kit+ GIST Patient Support
and Co-Pay
Assistance Program

 
 
 
RELATED LINKS Additional
Patient Resources About GLEEVEC®















































 
 
     

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.
 
 



Enroll Now