Yondelis Caution For Usage

Special precautions for disposal and other handling: Preparation for intravenous infusion: Yondelis must be reconstituted and further diluted prior to intravenous infusion. Appropriate aseptic techniques must be used to prepare the infusion solution (see Instructions for reconstitution and Instructions for dilution as follows).
When used in combination with PLD, the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis. The use of any diluent other than 50 mg/ml (5%) glucose solution for infusion for this line flushing may cause precipitation of PLD (see also PLD Summary of Product Characteristics for specific handling instructions).
Instructions for reconstitution: Each vial containing 1 mg of trabectedin is reconstituted with 20 ml of water for injections. The solution obtained has a concentration of 0.05 mg/ml and is for single-use only.
A syringe is used to inject 20 ml of sterile water for injections into the vial. The vial must be shaken until complete dissolution. The reconstituted solution results in a clear, colourless or slightly yellowish solution, essentially free of visible particles.
This reconstituted solution contains 0.05 mg/ml of trabectedin. It requires further dilution and is for single-use only.
Instructions for dilution: The reconstituted solution should be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion. The required volume should be calculated as follows: See equation.

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If administration is to be made through a central venous line, the appropriate amount of reconstituted solution should be withdrawn from the vial and added to an infusion bag containing ≥50 ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion), the concentration of trabectedin in the infusion solution being ≤0.030 mg/ml.
If central venous access is not feasible and a peripheral venous line has to be used, the reconstituted solution should be added to an infusion bag containing ≥1,000 ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion).
Parenteral solutions should be inspected visually for particles prior to administration. Once the infusion is prepared, it should be administered immediately.
Instructions for handling and disposal: Yondelis is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised during handling. Procedures for proper handling and disposal of cytotoxic medicinal products must be followed. Personnel should be trained in the correct techniques to reconstitute and dilute the medicinal product and should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution. Pregnant staff must be excluded from working with this medicinal product.
Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water.
No incompatibilities have been observed between Yondelis and type I glass bottles, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs and titanium implantable vascular access systems.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Incompatibilities: Yondelis must not be mixed or diluted with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.