Trabectedin (Yondelis) is an innovative alkylating agent. As an important anti-tumor treatment option, it plays a key role in the therapy of soft tissue sarcomas.
What Are the Indications for Trabectedin (Yondelis)?
Primary Therapeutic Indications
Trabectedin is approved for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have previously received an anthracycline-containing treatment regimen.
Characteristics of Applicable Populations
Disease status: Locally advanced or metastatic lesions.
Histological type: Liposarcoma (including dedifferentiated, myxoid round cell, or pleomorphic subtypes) or leiomyosarcoma.
Treatment history: Must have specific prior treatment experience.
Specifications and Properties of Trabectedin (Yondelis)
Basic Drug Characteristics
Dosage form: Injection.
Packaging form: Single-dose vial.
Specification and content: Each vial contains 1 mg of trabectedin.
Physical Properties
Appearance: White to off-white lyophilized powder/cake.
Reconstituted solution: Clear, colorless to pale tan.
Composition
Active ingredient: Trabectedin.
Excipients:
Potassium dihydrogen phosphate: 27.2 mg.
Sucrose: 400 mg.
Phosphoric acid and potassium hydroxide (used to adjust pH to 3.6–4.2).
Chemical Properties
Trabectedin is an alkylating agent, with the chemical name (1'R,6R,6aR,7R,13S,14S,16R)-5(acetyloxy)-3',4',6,6a,7,13,14,16-octahydro-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trimethylspiro[6,16-(epithiopropoxymethano)-7,13-imino-12H-1,3-dioxolo[7,8]isoquinolino[3,2-b][3]benzazocine-20,1'(2'H)-isoquinoline]-19-one.
Its molecular formula is C₃₉H₄₃N₃O₁₁S, with a molecular weight of 761.84 daltons.
Storage and Handling Methods of Trabectedin (Yondelis)
Storage Requirements
Must be stored in a refrigerated environment at 2°C to 8°C (36°F to 46°F).
Freezing is strictly prohibited.
Environmental Protection
Should be kept in the original carton to protect from light exposure.
Follow special handling and disposal procedures for hazardous drugs.
Reconstitution Steps
Using aseptic technique, inject 20 mL of sterile water for injection into the vial.
Shake the vial until completely dissolved.
The concentration of the reconstituted solution is 0.05 mg/mL.
Solution Inspection
The solution must be carefully inspected for particulates and discoloration before use.
The vial should be discarded if particulates or significant brown discoloration are observed.
