DECITABINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

INN (International Name):

DECITABINE

Composition:

DECITABINE 50 mg in 10 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 [Click here to enter Use in Specific Populations] 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, administra

Product summary:

Decitabine for injection is a sterile, white to off white lyophilized powder/cake, supplied as 50 mg single-dose vial NDC 68001-347-28. Vial individually packaged in a shelf pack with NDC 68001-347-36. 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
BLUEPOINT LABORATORIES
----------
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
•
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)
•
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) (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions (> 50%) are neutropenia,
thrombocytopenia, anemia, and pyrexia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CIPLA LTD. AT 1
866-604-3268 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Starting Dose
2.2 Dose Modifications for Toxicity
Non-hematologic