DECITABINE kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

DECITABINE

Composition:

DECITABINE 50 mg in 10 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). In animal reproduction studies, administration of decitabine to pregnan

Product summary:

DRUG PRODUCT White to off white lyophilized powder in 20 mL colorless tubular glass single-dose vial with grey bromo butyl rubber stopper and sealed with baby blue flip top aluminum seal. Each vial contains 50 mg decitabine. (NDC 47335-361-40) DILUENT Clear colorless solution filled in 10 mL colorless tubular glass vial with grey bromo butyl stopper sealed with transparent flip top aluminum seal. Each vial contains 68 mg monobasic potassium phosphate, 11.6 mg sodium hydroxide and 10 mL water for injection. (NDC 47335-362-40) The carton contains 1 vial of drug product, and 1 vial of sterile diluent. (NDC 47335-361-41) Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

DECITABINE- DECITABINE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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) (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 with the supplied diluent.
(3) (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) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC. AT 1-800-818-4555
OR FDA AT 1-8