Trabectedin (3 brand names, 3 dosage forms, 2 routes)
Available dosage forms: POWDER, SOLUTION, INJECTABLE.
Routes of administration: INTRAVENOUS, INJECTION.
Brand Names
- EVDI
- TRABECTEDIN
- YONDELIS
Indications and Usage
EVDI is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen [see Clinical Studies (14)].
Contraindications
EVDI is contraindicated in patients with known severe hypersensitivity, including anaphylaxis, to trabectedin.
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Anaphylaxis [see Contraindications (4)] Neutropenic Sepsis [see Warnings and Precautions (5.1)] Rhabdomyolysis [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Cardiomyopathy [see Warnings and Precautions (5.4)] Capillary Leak Syndrome [see Warnings and Precautions (5.5)] Extravasation Resulting in Tissue Necrosis [see Warnings and Precautions (5.6)]
Drug Interactions
Drug Interactions
Mechanism of Action
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.
Overdosage
There is no specific antidote for EVDI. Hemodialysis is not expected to enhance the elimination of EVDI because trabectedin is highly bound to plasma proteins (97%) and not significantly renally excreted.