YONDELIS- trabectedin injection, powder, lyophilized, for solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Trabectedin (UNII: ID0YZQ2TCP) (Trabectedin - UNII:ID0YZQ2TCP)

MAH:

Janssen Products, LP

INN:

Trabectedin

composition:

Trabectedin 0.05 mg in 1 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

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

authorization_status:

New Drug Application

SPC

YONDELIS- TRABECTEDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
JANSSEN PRODUCTS, LP
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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