Trabectedin is available as a lyophilized powder in single-use vials containing 1 mg of the drug.3177 Each vial also contains potassium dihydrogen phosphate 27.2 mg, sucrose 400 mg, and phosphoric acid and potassium hydroxide to adjust the pH.3177 Each vial should be reconstituted with 20 mL of sterile water for injection to yield a solution containing trabectedin 0.05 mg/mL.3177 Vials should be shaken until the powder has completely dissolved.3177 The reconstituted solution should be visually inspected for particulate matter and discoloration prior to dilution; if particulate matter is present or discoloration occurs, the solution should not be used.3177 The appropriate dose of the reconstituted solution should be withdrawn from the vial immediately after reconstitution and diluted in 500 mL of sodium chloride 0.9% or dextrose 5%.3177
pH
The reconstituted solution of trabectedin has a pH from 3.6 to 4.2.3177
Trade Name(s)
Yondelis
Trabectedin is administered as an intravenous infusion over 24 hours through a central venous line following dilution of the reconstituted solution in 500 mL of sodium chloride 0.9% or dextrose 5%.3177 Trabectedin should be administered using an infusion set with a 0.2-µm polyethersulfone inline filter.3177
As with other toxic drugs, applicable special handling and disposal procedures for trabectedin should be followed.3177
Extravasation of trabectedin resulting in tissue necrosis and requiring debridement may occur; trabectedin should be administered through a central venous line.3177
Trabectedin is a white to off-white powder or cake that forms a clear, colorless to pale brownish-yellow solution when reconstituted with sterile water for injection.3177 Intact vials should be stored under refrigeration at 2 to 8°C.3177
The reconstituted solution should be diluted immediately following reconstitution.3177 Both the reconstituted solution and the drug diluted for infusion were found to be physically compatible and chemically stable for up to 30 hours when stored at room temperature in ambient light or under refrigeration.3178 The total time from reconstitution and dilution through completion of administration should not exceed 30 hours; any unused portion of the reconstituted solution or the drug diluted for infusion should be discarded after that time.3177
Sorption
Trabectedin diluted for infusion is noted to be compatible with Type I colorless glass vials; polyvinylchloride (PVC) and polyethylene bags and tubing; polyethylene and polypropylene mixture bags; polyethersulfone inline filters; titanium, platinum, or plastic ports; silicone and polyurethane catheters; and pumps having contact surfaces made of PVC, polyethylene, or a combination of polyethylene and polypropylene.3177
Filtration
The diluted solution for infusion should be administered through an infusion set with a 0.2-µm polyethersulfone inline filter.3177
For a list of references cited in the text of this monograph, search the monograph titled References.