DECITABINE injection, powder, lyophilized, for solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

DECITABINE (UNII: 776B62CQ27) (DECITABINE - UNII:776B62CQ27)

可用日期:

Nivagen Pharmaceuticals, Inc.

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. None. Risk Summary Based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)] . Limited published data on decitabine for injection use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). In animal reproduction studies, administration of decitabin

產品總結:

Decitabine for injection is a sterile, white to almost white lyophilized powder for intravenous use supplied as:                   NDC 75834-190-01, 50 mg single-dose vial individually packaged in a carton. Store vials at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

产品特点

DECITABINE - DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
NIVAGEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DECITABINE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DECITABINE FOR
INJECTION.
DECITABINE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Decitabine for injection is a nucleoside metabolic inhibitor indicated
for treatment of adult patients with
myelodysplastic syndromes (MDS) including previously treated and
untreated, de novo and secondary
MDS of all French-American-British subtypes (refractory anemia,
refractory anemia with ringed
sideroblasts, refractory anemia with excess blasts, refractory anemia
with excess blasts in transformation,
and chronic myelomonocytic leukemia) and intermediate-1,
intermediate-2, and high-risk International
Prognostic Scoring System groups. (1)
DOSAGE AND ADMINISTRATION
Three Day Regimen: Administer decitabine for injection at a dose of 15
mg/m by continuous
intravenous infusion over 3 hours repeated every 8 hours for 3 days.
Repeat cycle every 6 weeks. (2.1)
Five Day Regimen: Administer decitabine for injection at a dose of 20
mg/m by continuous intravenous
infusion over 1 hour repeated daily for 5 days. Repeat cycle every 4
weeks. (2.1)
DOSAGE FORMS AND STRENGTHS
For Injection: 50 mg of decitabine as a lyophilized powder in a
single-dose vial for reconstitution. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Neutropenia and Thrombocytopenia: Perform complete blood counts and
platelet counts. (5.1)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of
reproductive potential of the potential
risk to a fetus and to use effective contraception (5.2, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (>50%) are neutropenia,
thrombocytopenia, anemia, and pyrexia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NIVAGEN
PHARMACEUTICALS, INC. AT 1-
877-977-0687 OR FDA AT 1-800-F