Trabectedin (Yondelis) is an injectable alkylating agent indicated for the treatment of specific types of soft tissue sarcoma. First approved for marketing in the United States in 2015, this medication offers a new treatment option for patients with advanced sarcoma whose disease has progressed following prior chemotherapy with specific regimens.

What are the Indications for Trabectedin (Yondelis)?

Primary Indications

Trabectedin is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma.

The disease of these patients has progressed after prior chemotherapy containing anthracyclines.

Key Premises for Use

Before initiating trabectedin treatment, it must be confirmed that the patient meets the following criteria: First, a pathological diagnosis of liposarcoma (dedifferentiated, myxoid/round cell, or pleomorphic type) or leiomyosarcoma has been established.

Second, the patient’s prior treatment history must include an anthracycline-based chemotherapy regimen.

Dosage Form and Appearance of Trabectedin (Yondelis)

Dosage Form

Trabectedin is supplied as a sterile lyophilized powder for injection.

It is commercially available in single-dose glass vials, each containing 1 mg of trabectedin as the active ingredient.

Each vial also contains potassium dihydrogen phosphate, sucrose, phosphoric acid, and potassium hydroxide as excipients, which are used to maintain the stability of the medication and adjust the pH value of the reconstituted solution.

Physical Appearance

When stored, the contents in the vial appear as a white to off-white powder or cake.

Prior to use, it needs to be reconstituted with sterile water for injection.

After complete dissolution, the resulting solution should be a clear, colorless to light tan liquid, free of visible particles.

If the solution becomes turbid, precipitates, or shows abnormal discoloration, it indicates that the medication may have deteriorated and must not be used.

Storage Method of Trabectedin (Yondelis)

Storage Conditions

Unopened original vials of trabectedin must be stored under refrigerated conditions at 2°C to 8°C (36°F to 46°F) at all times.

This means the medication should be stored in a dedicated medical refrigerator, and should not be placed in areas with potential temperature fluctuations such as refrigerator door shelves.

The medication must not be frozen.

Handling after Reconstitution and Use

For clinical use, the medication must be handled by professional medical staff under sterile conditions.

After reconstituting the lyophilized powder with 20 mL of sterile water for injection, it should be further diluted in an infusion bag within the specified time.

The reconstituted solution must be used within 30 hours. Any remaining portion should be discarded in accordance with the medical institution’s procedures for handling cytotoxic waste.