Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
DECITABINE (UNII: 776B62CQ27) (DECITABINE - UNII:776B62CQ27)
BluePoint Laboratories
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 [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
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).
Abbreviated New Drug Application
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 Soma hati kamili