Trabectedin is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen. It is available as injection and powder for injection for intravenous use. MedsAcross supplies Trabectedin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
YONDELIS ® is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen. YONDELIS is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen
Source: US FDA prescribing information
Trabectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.
Source: US FDA prescribing information
Administer at 1.5 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line. Premedication: dexamethasone 20 mg intravenously, 30 min before each infusion. Hepatic Impairment: Administer at 0.9 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line in patients with moderate hepatic impairment
Source: US FDA prescribing information
YONDELIS is contraindicated in patients with known severe hypersensitivity, including anaphylaxis, to trabectedin. Known hypersensitivity to trabectedin
Source: US FDA prescribing information
Neutropenic sepsis: Severe, and fatal, neutropenic sepsis may occur. Monitor neutrophil count during treatment. Withhold YONDELIS for neutrophil count < 1,500/mcL. Rhabdomyolysis: Rhabdomyolysis may occur. Monitor creatine phosphokinase (CPK) levels prior to each administration. Withhold YONDELIS for CPK more than 2.5 times the upper limit of normal. Hepatotoxicity: Hepatotoxicity may occur. Monitor and delay and/or reduce dose if needed. Cardiomyopathy: Severe and fatal cardiomyopathy can occur. Patients with left ventricular ejection fraction (LVEF) < lower limit of normal, prior cumulative anthracycline dose of ≥300 mg/m 2, age ≥65 years, or a history of cardiovascular disease may be at increased risk of developing new or worsening cardiac dysfunction. Discontinue YONDELIS in patients who develop decreased LVEF or cardiomyopathy.
Source: US FDA prescribing information
The following adverse reactions are discussed in more detail in other sections of the labeling: Anaphylaxis Neutropenic Sepsis Rhabdomyolysis Hepatotoxicity Cardiomyopathy Capillary Leak Syndrome Extravasation Resulting in Tissue Necrosis The most common (≥20%) adverse reactions are nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache. The most common (≥5%) grades 3–4 laboratory abnormalities are: neutropenia, increased ALT, thrombocytopenia, anemia, increased AST, and increased creatine phosphokinase.
Source: US FDA prescribing information
CYP3A inhibitors: Avoid concomitant strong CYP3A inhibitors. CYP3A inducers: Avoid concomitant strong CYP3A inducers Effect of Cytochrome CYP3A Inhibitors Coadministration of YONDELIS with ketoconazole, a strong CYP3A inhibitor, increased systemic exposure of trabectedin by 66%. Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. If a strong CYP3A inhibitor for short-term use (i.e., less than 14 days) must be used, administer the strong CYP3A inhibitor 1 week after the YONDELIS infusion, and discontinue it the day prior to the next YONDELIS infusion.
Source: US FDA prescribing information
Store YONDELIS vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Trabectedin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Evdi 1 mg/20 mL injectionIntravenous Cold chain | Apotex | US FDA | Available on request |
| Yondelis 0.05 mg/mL powder for injectionIntravenous Cold chain | Janssen Products | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Trabectedin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Trabectedin, including Evdi, Yondelis.
Yes. The US FDA first approved Trabectedin on 23 October 2015, according to Drugs@FDA.
Yes. Trabectedin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Trabectedin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Trabectedin is classified under ATC code L01CX01 (Trabectedin).
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