Product Description.:
NVR, S A
tablet , film-coated , gold , scored , round round
Dark yellow to brownish orangeBeveled edgeBiconvex
GLEEVEC? (imatinib mesylate) tablets are indicated for:
Newly diagnosed adult patients with Philadelphia chromosome?positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP)
Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in 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 dermatofibrosarcoma protuberans (DFSP) that cannot be surgically removed, keeps recurring, and/or has spread to other parts of the body 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 after surgery who have had their GISTs completely removed
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 b
