DECITABINE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NorthStar RxLLC

INN (International Name):

DECITABINE

Composition:

DECITABINE 50 mg in 20 mL

Administration route:

INTRAVENOUS

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)] . 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 decitabine to pregnant mice and rats durin

Product summary:

Decitabine for injection is a sterile, white to off white lyophilized powder/cake, supplied as 50 mg single-dose vial individually packaged in a carton. NDC 16714-749-01. Storage Store vials at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DECITABINE- DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
NORTHSTAR RXLLC
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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. (2.2)
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 NORTHSTAR RX LLC AT 1
800-206-7821 OR FDA AT 1-800-
FDA-1088 OR www.fda.gov/medwat