Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
IMATINIB MESYLATE (UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI)
Aurobindo Pharma Limited
ORAL
PRESCRIPTION DRUG
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
Each film-coated tablet contains 100 mg or 400 mg of imatinib free base. Imatinib Mesylate Tablets, 100 mg are very dark yellow to brownish orange film-coated tablets, round, biconvex with bevelled edges, debossed with '100' on one side, and score on the other side. Bottles of 90 NDC 59651-240-90 Imatinib Mesylate Tablets, 400 mg are very dark yellow to brownish orange film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with '400' on one side and score on the other side. Bottles of 30 NDC 59651-241-30 Cartons of 30 (3 x 10) Unit-dose Tablets NDC 59651-241-03 Storage and Handling Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container, USP. 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.
Abbreviated New Drug Application
IMATINIB MESYLATE - IMATINIB MESYLATE TABLET, FILM COATED AUROBINDO PHARMA LIMITED ---------- 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 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 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 Kit (CD117) po Přečtěte si celý dokument