Trabectedin

What it is and how it works

Mechanism of Action Trabectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.

Mechanism class: Alkylating Activity

Indications

® is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen . YONDELIS is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen

Dosage and administration (summary)

Administer at 1.5 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line ( 2.1 , 2.6 ) Premedication: dexamethasone 20 mg intravenously, 30 min before each infusion Hepatic Impairment: Administer at 0.9 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line in patients with moderate hepatic impairment Recommended Dosage The recommended dose is 1.5 mg/m 2 administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks), until disease progression or unacceptable toxicity.

Contraindications

is contraindicated in patients with known severe hypersensitivity, including anaphylaxis, to trabectedin. Known hypersensitivity to trabectedin

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 ( 2.4 , 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. ( 2.4 , 5.2 ) Hepatotoxicity: Hepatotoxicity may occur. Monitor and delay and/or reduce dose if needed Cardiomyopathy: Severe and fatal cardiomyopathy can occur.

Pregnancy

Pregnancy Risk Summary Based on its mechanism of action, trabectedin can cause fetal harm when administered during pregnancy . 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.

Storage and supply

Storage and Handling Store YONDELIS vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F). YONDELIS is a hazardous drug. Follow applicable special handling and disposal procedures. 1

Source: Trabectedin (Yondelis) — US FDA prescribing information, 2026-01-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.