국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
Trabectedin (UNII: ID0YZQ2TCP) (Trabectedin - UNII:ID0YZQ2TCP)
Janssen Products, LP
Trabectedin
Trabectedin 0.05 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
YONDELIS® is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen [see Clinical Studies (14)] . YONDELIS is contraindicated in patients with known severe hypersensitivity, including anaphylaxis, to trabectedin. Risk Summary Based on its mechanism of action, trabectedin can cause fetal harm when administered during pregnancy [see Clinical Pharmacology (12.1)] . There are no available data with the use of YONDELIS during pregnancy. Animal reproductive and developmental studies at relevant doses have not been conducted with trabectedin; however, placental transfer of trabectedin was demonstrated in pregnant rats. Advise pregnant woman of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population are unknown; however, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recog
YONDELIS is supplied in a single-dose glass vial containing 1 mg trabectedin. Each carton contains one vial (NDC: 59676-610-01). Storage and Handling Store YONDELIS vials in a refrigerator at 2°C to 8°C (36°F to 46°F). YONDELIS is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
New Drug Application
YONDELIS- TRABECTEDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION JANSSEN PRODUCTS, LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE YONDELIS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YONDELIS. YONDELIS (TRABECTEDIN) FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2015 INDICATIONS AND USAGE YONDELIS is an alkylating drug indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen (1) DOSAGE AND ADMINISTRATION Administer at 1.5 mg/m body surface area as a 24-hour intravenous infusion, every 3 weeks through a central venous line (2.1, 2.5) Premedication: dexamethasone 20 mg intravenously, 30 min before each infusion (2.2) Hepatic Impairment: Administer at 0.9 mg/m body surface area as a 24-hour intravenous infusion, every 3 weeks through a central venous line in patients with moderate hepatic impairment (2.1) DOSAGE FORMS AND STRENGTHS For injection: 1 mg sterile lyophilized powder in a single-dose vial (3) CONTRAINDICATIONS Known hypersensitivity to trabectedin (4) WARNINGS AND PRECAUTIONS Neutropenic sepsis: Severe, and fatal, neutropenic sepsis may occur. Monitor neutrophil count during treatment. Withhold YONDELIS for neutrophil count < 1,500/mcL (2.3, 5.1) Rhabdomyolysis: Rhabdomyolysis may occur. Monitor creatine phosphokinase (CPK) levels prior to each administration. Withhold YONDELIS for CPK more than 2.5 times the upper limit of normal. (2.3, 5.2) Hepatotoxicity: Hepatotoxicity may occur. Monitor and delay and/or reduce dose if needed (5.3) Cardiomyopathy: Severe and fatal cardiomyopathy can occur. Patients with left ventricular ejection fraction (LVEF) < lower limit of normal, prior cumulative anthracycline dose of ≥300 mg/m , age ≥65 years, or a history of cardiovascular disease may be at increased risk of developing new or worsening cardiac dysfunction. Discontinue YONDELIS in patients who develop decreased 전체 문서 읽기