Trabectedin (Yondelis) is an alkylating antineoplastic agent indicated for the treatment of specific soft tissue sarcomas. It is used in patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have previously received anthracycline-containing chemotherapy regimens.

What are the Precautions for Using Trabectedin (Yondelis)?

Strict Adherence to Indications and Contraindications

Trabectedin is indicated only for patients with advanced soft tissue sarcomas of specific pathological types, namely unresectable or metastatic liposarcoma or leiomyosarcoma, who have previously received anthracycline-containing chemotherapy.

The drug is contraindicated in patients with known severe hypersensitivity reactions (including anaphylactic shock) to trabectedin or any excipients in the formulation.

Standardized Dosage and Administration Method

The recommended dose is 1.5 mg per square meter of body surface area, administered as a continuous intravenous infusion over 24 hours via a central venous catheter, repeated every 3 weeks.

Thirty minutes prior to administration, 20 mg of dexamethasone must be administered intravenously as premedication to reduce the risk of certain adverse reactions.

The drug must be administered through an infusion set equipped with an inline 0.2-micron polyethersulfone filter to minimize the risk of pathogenic contamination.

Co-infusion with other drugs is strictly prohibited.

Administration in Special Populations

Administration during pregnancy may cause fetal harm. Women of childbearing potential must use effective contraceptive measures during treatment and for at least 2 months after the last dose.

Male patients with female partners of childbearing potential should use effective contraceptive measures during treatment and for at least 5 months after the last dose.

Lactating women should discontinue breastfeeding during the course of treatment.

Caution is required when administering the drug to elderly patients and those with hepatic or renal impairment. No recommended dose has been established for patients with severe hepatic impairment.

Management of Drug Interactions

Trabectedin is primarily metabolized by the CYP3A enzyme system.

Concomitant use with potent CYP3A inhibitors (e.g., ketoconazole, clarithromycin, certain antiviral drugs) or inducers (e.g., rifampicin, St. John’s wort) should be avoided.

Consumption of grapefruit or grapefruit juice should also be avoided during treatment.

Medication Monitoring for Trabectedin (Yondelis)

Hematological Monitoring

Neutropenia and infection risk: Neutropenia is a common and potentially fatal adverse reaction.

The absolute neutrophil count (ANC) must be monitored before each dose. If the count is below 1,500/μL, administration should be withheld.

Permanent dose reduction is required for patients who develop febrile neutropenia or severe, persistent neutropenia.

Hepatic Function Monitoring

Hepatotoxicity is a key safety risk of trabectedin. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase levels must be measured before each dose.

Depending on the severity of transaminase and bilirubin elevation, interventions such as dose delay, dose reduction, or permanent treatment discontinuation should be implemented.

Creatine Phosphokinase Monitoring and Rhabdomyolysis

The drug may cause muscle injury and even rhabdomyolysis. Serum creatine phosphokinase (CPK) levels should be monitored before each dose.

If the CPK level exceeds 2.5 times the upper limit of normal, administration should be withheld.

Permanent treatment discontinuation is mandatory in cases of confirmed rhabdomyolysis.