HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Gleevecsafely and effectively. See full prescribing information for Gleevec.
GLEEVEC (imatinib mesylate) tablets for oral use
Initial U.S. Approval: 2001
RECENT MAJOR CHANGES
Indications and Usage Newly Diagnosed Ph+ CML (1.1)04/2011

Warnings and Precautions Growth retardation in children (5.12)04/2011

Warnings and Precautions Tumor Lysis Syndrome (5.13)04/2011
INDICATIONS AND USAGE
Gleevec is a kinase inhibitor indicated for the treatment of:

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (1.1).

Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy (1.2)

Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) (1.3)

Adult patients with myelodysplastic/ myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements (1.4)

Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown (1.5)

Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown (1.6)

Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) (1.7)

Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.8)

Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.Approval is based on recurrence-free survival with a median follow-up of 14 months. Clinical benefit has not been demonstrated by a long term effect on recurrence-free survival or survival. (1.9)

 
DOSAGE AND ADMINISTRATION
Adults with Ph+ CML CP (2.1):400 mg/day

Adults with Ph+ CML AP or BC (2.1):600 mg/day

Pediatrics with Ph+ CML CP (2.2):340 mg/m2/day

Adults with Ph+ ALL (2.3):600 mg/day

Adults with MDS/MPD (2.4):400 mg/day

Adults with ASM (2.5):100 mg/day or 400 mg/day

Adults with HES/CEL (2.6):100 mg/day or 400 mg/day

Adults with DFSP (2.7):800 mg/day

Adults with metastatic and/or unresectable GIST (2.8):400 mg/day

Adjuvant treatment of adults with GIST (2.8): 400 mg/day

Patients with mild to moderate hepatic impairment (2.9):400 mg/day

Patients with severe hepatic impairment (2.9):300 mg/day
All doses of Gleevec should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Gleevec can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400 mg tablet to reduce exposure to iron.

 
DOSAGE FORMS AND STRENGTHS
Tablets (scored): 100 mg and 400 mg (3)

 
CONTRAINDICATIONS
None (4)