What information does the detailed instructions for Trabectedin include?

1. Common names: Trabectedin, YONDELIS, trabectedin (transliteration)

2. Indications:

Trabectedin is indicated for patients with unresectable or metastatic liposarcoma or leiomyosarcoma (soft tissue sarcoma) who have been treated with anthracycline-containing drugs. Such patients often face the dilemma of limited treatment options. Trabectedin provides them with new hope through its unique mechanism of action. Liposarcoma and leiomyosarcoma are rare but aggressive tumor types that often do not respond well to standard chemotherapy, so the introduction of trabectedin gives clinicians additional treatment tools.

3. Usage and dosage:

1. Recommended dosage: The dosage of trabectedin is 1.5 mg/m2, which should be infused intravenously for 24 hours through a central venous catheter every 21 days (3 weeks) until the disease worsens or unacceptable toxicity occurs.

(1) Liver function impairment: For patients with moderate liver function impairment (bilirubin level greater than 1.5 times to 3 times the upper limit of normal, AST, ALT <8 times the upper limit of normal), the recommended dose is 0.9 mg/m2. Do not use trabectedin in patients with severe hepatic impairment (bilirubin levels more than 3 times the upper limit of normal, and any AST and ALT).

2. Preoperative medication: Inject 20 mg of dexamethasone intravenously 30 minutes before each dose of trabectedin.

4. Adverse reactions:

In clinical studies of trabectedin, the most common adverse reactions include nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea and headache; the most common laboratory abnormalities are increased AST or ALT, increased alkaline phosphatase, hypoalbuminemia, increased creatinine, increased creatine phosphokinase, anemia, neutropenia and thrombocytopenia.

5. Supply and storage:

Trabectedin is supplied in single-dose glass vials, each containing1 mg of trabectedin. In order to ensure the effectiveness of the drug, trabectedin needs to be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) to avoid environmental factors such as high temperature and humidity that may affect the quality of the drug.

6. Taboo:

Trabectedin is contraindicated in patients with a known severe allergic reaction, including anaphylaxis, to trabectedin.

7. Mechanism of action:

The mechanism of action of trabectedin is relatively complex. As an alkylating drug, it can bind toguanine residues in the minor groove of DNA to form a stable adduct. This process causes the DNA's helical structure to bend, interfering with the DNA's normal function. The formation of adducts triggers a series of biochemical events that affect the activity of DNA-binding proteins, including some key transcription factors and DNA repair pathways. This interference ultimately leads to cell cycle disruption, which in turn triggers cell death. The uniqueness of this mechanism allows trabectedin to show good results in treating tumors, especially in patients who are insensitive to other treatment options.

In conclusion, trabectedin provides a new treatment option for patients with unresectable or metastatic liposarcoma and leiomyosarcoma. Through reasonable usage and dosage, effective management of adverse reactions and compliance with contraindications, the treatment effect can be maximized and the patient's quality of life can be improved.

Reference materials:https://www.drugs.com/monograph/trabectedin.html