IMATINIB MESYLATE tablet, coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Bryant Ranch Prepack

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 PDGFR (platelet-derived growth factor receptor) 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-PDGFR€α fusion kinase (mutational analysis or FISH demonstration of CHIC

Přehled produktů:

Each film-coated tablet contains 400 mg of imatinib free base. 400 mg Tablets Film-coated capsule shaped brown tablets. One side debossed with "0599" and bisected on the other side. Bottles of 30 tablets NDC 63629-2068-1 Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

IMATINIB MESYLATE- IMATINIB MESYLATE TABLET, COATED
BRYANT RANCH PREPACK
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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
RECENT MAJOR CHANGES
Indications and Usage (1.5, 1.6)
08/2020
Dosage and Administration (2.6, 2.7)
08/2020
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 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€α 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 (1.7)
Adult patients with unresectable, recurrent and/or metastatic
dermatofibrosarcoma protuberans
(DFSP) (1.8)
DOSAGE AND ADMINISTRATION
Adults with Ph+ CML CP (2.2):
400 mg/day
Adults with Ph+ CML AP or BC (2.2):
600 mg/day
Pediatrics with P