IMATINIB MESYLATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

IMATINIB MESYLATE

Composition:

IMATINIB 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. Adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown. Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridiz

Product summary:

Each film-coated tablet contains 100 mg or 400 mg of imatinib free base. Imatinib mesylate tablets are available as follows: Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children. Do not crush imatinib mesylate tablets. Avoid direct contact of crushed tablets with the skin or mucous membranes. If such contact occurs, wash thoroughly as outlined in the references. Avoid exposure to crushed tablets.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IMATINIB MESYLATE- IMATINIB MESYLATE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMATINIB MESYLATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IMATINIB MESYLATE
TABLETS.
IMATINIB MESYLATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Imatinib mesylate tablets are 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 platelet-
derived growth factor receptor (PDGFR) 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-PDGFRα fusion kinase (mutational analysis or
fluorescence in situ hybridization [FISH]
demonstration of CHIC2 allele deletion) and for patients with HES
and/or CEL who are FIP1L1-PDGFRα
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 K