TRABECTEDIN

Other

Brand names: YONDELIS

Intravenous

Mechanism of Action

12.1 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.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS YONDELIS is contraindicated in patients with known severe hypersensitivity
• including anaphylaxis
• to trabectedin. Known hypersensitivity to trabectedin ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Neutropenic sepsis: Severe, and fatal, neutropenic sepsis may occur
2%) receiving dacarbazine; cardiomyopathy leading to death occurred in 1 patient (0
Patients with 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 cardiac dysfunction
5 Capillary Leak Syndrome Capillary leak syndrome (CLS) characterized by hypotension, edema, and hypoalbuminemia has been reported with YONDELIS, including serious CLS resulting in death

Known Side Effects

4 documented side effects by frequency

Nausea

1-10%

Vomiting

1-10%

Weakness

0.1-1%

Fever

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous