Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
Decitabine (UNII: 776B62CQ27) (Decitabine - UNII:776B62CQ27)
Dr.Reddy's Laboratories Limited
Decitabine
Decitabine 50 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
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 decitabine
Decitabine for injection is a sterile, white to almost white lyophilized powder for intravenous use supplied as: NDC 55111-556-10, 50 mg single-dose vial individually packaged in a carton. Store vials at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].
Abbreviated New Drug Application
DECITABINE- DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION DR.REDDY'S LABORATORIES LIMITED ---------- 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, intermediate2, 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/mby 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) (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 DR. REDDY’S LABORATORIES INC., AT 1- 888-375-3784 OR F Прочитать полный документ