GLEEVEC imatinib mesylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IMATINIB MESYLATE (UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI)

Available from:

Avera McKennan Hospital

INN (International Name):

IMATINIB MESYLATE

Composition:

IMATINIB 100 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

GLEEVEC- IMATINIB MESYLATE TABLET
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLEEVEC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GLEEVEC.
GLEEVEC (IMATINIB MESYLATE) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions (5)??????????1/2015
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)
Pediatric patients with newly diagnosed Philadelphia chromosome
positive acute lymphoblastic leukemia (Ph+ ALL) in
combination with chemotherapy (1.4)
Adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated with PDGFR (platelet-derived
growth factor receptor) gene re-arrangements (1.5)
Adult patients with aggressive systemic mastocytosis (ASM) without the
D816V c-Kit mutation or with c-Kit mutational
status unknown (1.6)
Adult patients with hypereosinophilic syndrome (HES) and/or chronic
eosinophilic leukemia (CEL) who have the
FIP1L1-PDGFR?? fusion kinase (mutational analysis or FISH
demonstration of CHIC2 allele deletion) and for patients
with HES and/or CEL who are FIP1L1-PDGFR?? fusion kinase negative or
unknown (1.7)
Adult patients with unresectable, recurrent and/or metastatic
dermatofibrosarcoma protuberans (DFSP) (1.8)??
Patients with Kit (CD117) positive unresectable and/or metastatic
malignant gastrointestinal stromal tumors (GIST)
(1.9)
Adjuvant treatment of adult patients following resection of Kit
(CD117) positive GIST (1.10)
DOSAGE AND ADMINISTRATI