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Trabectedin is a new alkylating agent anti-tumor drug developed by Janssen, a subsidiary of Johnson & Johnson in the United States.
1. Common name : Trabectedin (Trabectedin)
2. Trade name : YONDELIS®
3. Dosage form : Lyophilized powder for injection Injection
4. Main ingredient :Each bottle contains 1 mg of trabectedin
Liposarcoma or leiomyosarcoma : For the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have previously received chemotherapy regimens containing anthracyclines.
1. Specifications of : 1mg/bottle (single-dose vial of lyophilized powder).
2. Characteristics of : White to off-white freeze-dried powder. After reconstitution, it becomes a colorless to light brown clear or slightly opalescent solution.
1. Recommended dose :1.5mg/m² body surface area, once every 3 weeks, 24-hour continuous intravenous infusion through central venous catheter.
2. Pretreatment : Inject 20 mg dexamethasone intravenously 30 minutes before each infusion.
3. Reconstitution method : Dissolve each bottle in 20mL of sterile water for injection, shake gently until completely dissolved, and then dilute in 500mL of 0.9% sodium chloride or 5% glucose injection.
4. Infusion requirements : Use a 0.2 micron polyethersulfone (PES) online filter and complete the infusion within 30 hours.
1. The first dose reduction of :1.2mg/m²; the second dose reduction of : 1.0mg/m².
2. Adjustment basis : Adjust according to the grade of adverse reactions such as neutropenia, hepatotoxicity, increased creatine kinase or left ventricular dysfunction.
1. Risk of infection : Screen for latent tuberculosis and monitor neutrophil count before treatment;
2. Hepatotoxicity : Test liver function, ALT/AST before each dose Pause when >2.5 times ULN;
3. Cardiac monitoring : Evaluate left ventricular function by echocardiography every 2-3 months during treatment;
4. Infusion safety : Administer only through central venous catheter to avoid extravasation leading to tissue necrosis.
1. Pregnant women : Disabled (may cause fetal damage);
2. Lactation : Discontinue during treatment and within 1 week after stopping the drug Anti-lactation;
3. Children : Safety has not been established;
4. Liver and kidney insufficiency : There is no recommended dose for patients with serum bilirubin > ULN or ALT/AST > 2.5 times ULN.
1. Common (≥20%) : Nausea (75%), fatigue (69%), vomiting (46%), constipation (37%) , decreased appetite (37%);
2. Severe reactions : Neutropenic sepsis (5%), rhabdomyolysis (0.8%), hepatotoxicity (35%), cardiomyopathy (6%).
It is contraindicated in those who are severely allergic to trabectedin or excipients.
1. Strong CYP3A inhibitor (such as ketoconazole): Avoid combined use, which increases trabectedin exposure by 66%;
2. Strong CYP3A inducer (such as rifampicin): Avoid combined use, which reduces trabectedin exposure by 31%.
Store unopened vials in a refrigerator at 2-8°C and away from light. After reconstitution, use within 1 hour at room temperature or within 4 hours of refrigeration.
Manufacturer :Janssen Products, LP (USA).
Note : If persistent infection, severe muscle pain or abnormal liver function occurs, seek medical attention immediately. Blood routine, liver function and cardiac function need to be monitored regularly during treatment.