Find Out About Another Ph+CML treatment


FIND OUT about another Ph+ CML treatment option that is available for patients in the Chronic Phase who are no longer responding or are intolerant to Gleevec ®

Goals: Reaching Treatment Milestones



Goals of treatment with GLEEVEC®:
Eliminate cells that contain the Ph+ chromosome (the underlying cause of Ph+ CML) or reduce their number as much as possible Return blood cells and bone marrow cells to their normal numbers and functions

To see whether or not you are responding to treatment, your doctor will do several tests at different times. In Ph+ CML, there are 3 levels of response to treatment: hematologic, cytogenetic, and molecular. Different tests are used to see if you've reached each of these levels. As your treatment continues, you will come to know these tests. Get as informed as you can. Be sure to talk to your health care team about anything you do not understand.

Tests What they measure
Hematologic Total number of white blood cells in your body
Cytogenetic Number of cells in your blood or bone marrow that have the Ph chromosome.
Molecular Identifies the presence of any remaining Ph+ cells by detecting very small amounts of Bcr-Abl protein in your blood and bone marrow

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, it 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.

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

Patients may respond to GLEEVEC® differently. They may get different results or take longer to get the same results. That's one of the reasons it's so important to stay with GLEEVEC® and give it time to work. Even if you have very good results with GLEEVEC®—and many patients do—it's important to keep taking it. A good result doesn't mean you are cured. It doesn't mean the Ph+ cells are gone. You still need to take your GLEEVEC® as directed. Read tips to help you stay on track with your treatment.

 

Please see the Important Safety Information and full Prescribing Information.
 
 
 
 
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.