Trabectedin (Yondelis) is an alkylating agent. First approved in the United States in 2015, it is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have previously received anthracycline-containing treatment regimens.

How to Use Trabectedin (Yondelis)

Standard Administration Regimen

Recommended Dose: The standard dose of trabectedin is 1.5 mg/m² body surface area, administered as a 24-hour continuous intravenous infusion via a central venous catheter, once every 3 weeks.

Pre-Administration Preparation: 30 minutes before each infusion, 20 mg of dexamethasone must be administered intravenously as premedication.

Infusion Requirements: An infusion set with a 0.2-micron polyethersulfone (PES) in-line filter must be used to reduce the risk of exposure to exogenous pathogens that may be introduced during solution preparation.

Drug Preparation Specifications

Using aseptic technique, inject 20 mL of sterile water for injection into each vial of the drug, and shake until completely dissolved.

The reconstituted solution should be clear, colorless to pale tan, with a concentration of 0.05 mg/mL.

Immediately withdraw the calculated volume of trabectedin and further dilute it in 500 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection.

Mixing with other drugs is prohibited, and the reconstituted solution must be used within 30 hours.

Dosage Adjustment of Trabectedin (Yondelis)

Standard Dosage Adjustment Regimen

First Dose Reduction: From 1.5 mg/m² to 1.2 mg/m².

Second Dose Reduction: From 1.2 mg/m² to 1.0 mg/m².

Once the dose is reduced, it should not be increased in subsequent treatment cycles.

Dosage Adjustment for Hematologic Toxicity

Platelets < 100,000/mcL or neutrophils < 1,500/mcL: Delay administration for up to 3 weeks.

Platelets < 25,000/mcL or neutrophils < 1,000/mcL accompanied by fever/infection: Reduce the dose by one level.

Indications for Permanent Discontinuation

Persistent adverse reactions resulting in administration delay exceeding 3 weeks.

Further dose reduction is still required after the dose has been reduced to 1.0 mg/m² in patients with normal liver function or to 0.3 mg/m² in patients with moderate liver impairment.

Severe hepatic dysfunction, capillary leak syndrome, or rhabdomyolysis.

Grade 3 or 4 cardiac adverse events or left ventricular ejection fraction (LVEF) below the lower limit of normal.

Medication for Special Populations with Trabectedin (Yondelis)

Patients with Hepatic Impairment

Moderate Hepatic Impairment (bilirubin level > 1.5–3 times the upper limit of normal, AST/ALT < 8 times the upper limit of normal): The recommended dose is 0.9 mg/m², administered as a 24-hour intravenous infusion once every 3 weeks.

Severe Hepatic Impairment (bilirubin level > 3 times the upper limit of normal, any AST/ALT): Use is prohibited.

Patients with Renal Impairment

Mild (creatinine clearance 60–89 mL/min) or moderate (creatinine clearance 30–59 mL/min) renal impairment: No dosage adjustment is required.

Severe renal impairment or end-stage renal disease: Pharmacokinetic data are lacking.