Trabectedin (Yondelis) is a new type of alkylating agent drug. Approved for marketing in the United States in 2015, it is specifically indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have previously received anthracycline-containing treatment regimens.

Precautions for Using Trabectedin (Yondelis)

Contraindications

Patients with a known hypersensitivity reaction to trabectedin or any of its components.

Patients with severe hepatic impairment (bilirubin level exceeding 3 times the upper limit of normal, accompanied by any abnormalities in AST and ALT).

Patients with urinary retention.

Patients with gastric emptying disorders.

Patients with untreated angle-closure glaucoma.

Key Technical Requirements for Administration

Must be administered via a central venous catheter.

Administered as a 24-hour continuous intravenous infusion.

One treatment cycle is 3 weeks.

30 minutes before each administration, 20 mg of dexamethasone must be intravenously injected as premedication.

Strictly follow the dose escalation regimen; unauthorized dose adjustment is prohibited.

Management of Drug Interactions

Strong CYP3A Inhibitors: Ketoconazole can increase the systemic exposure of trabectedin by 66%, and concurrent use should be avoided.

Strong CYP3A Inducers: Rifampicin can reduce the exposure of trabectedin by 31%, and concurrent administration should be avoided.

Other Antimuscarinic Drugs: May exacerbate anticholinergic side effects.

Medication Monitoring for Trabectedin (Yondelis)

Monitoring of Basic Physiological Indicators

Complete blood count (with focus on neutrophils and platelets).

Comprehensive liver function tests (ALT, AST, total bilirubin, alkaline phosphatase).

Determination of creatine phosphokinase (CPK) levels.

Assessment of left ventricular ejection fraction (LVEF) via echocardiography or MUGA scan.

Monitoring of Hematologic Toxicity

The incidence of neutropenia is 43%, of which grade 3–4 accounts for 43%.

The incidence of febrile neutropenia is 5%.

The incidence of neutropenic sepsis is 2.6%.

The incidence of thrombocytopenia is 59%, of which grade 3–4 accounts for 21%.

Monitoring of Liver Function

The incidence of grade 3–4 elevation in liver function test results is 35%.

The incidence of drug-induced liver injury is 1.3%.

The incidence of ALT or AST elevation exceeding 8 times the upper limit of normal is 18%.

Monitoring of Muscular System

The incidence of creatine phosphokinase elevation is 32%.

The incidence of grade 3–4 CPK elevation is 6%.

The incidence of death due to rhabdomyolysis is 0.8%.