What Yondelis contains:
- The active substance is trabectedin. Yondelis 0.25 mg: Each vial contains 0.25 mg of trabectedin. Yondelis 1 mg: Each vial contains 1 mg of trabectedin.
- The other ingredients are sucrose, potassium dihydrogen phosphate, phosphoric acid (for pH-adjustment) and potassium hydroxide (for pH-adjustment).
What Yondelis looks like and contents of the pack
Yondelis is a powder for concentrate for solution for infusion. The powder has a white to off-white colour and comes in a glass vial.
Each carton contains 1 vial of either 0.25 mg or 1 mg of trabectedin.
Marketing Authorisation Holder and Manufacturer:
Pharma Mar, S.A.
Avda. de los Reyes 1
Polígono Industrial La Mina
28770 Colmenar Viejo (Madrid)
Tel: +34 91 846 60 00
Fax: +34 91 846 60 01
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last approved in
This medicinal product has been authorised under ?Exceptional Circumstances?. This means that due to the rarity of soft tissue sarcoma, it has not been possible to obtain complete information on Yondelis in this indication.
The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
The following information is intended for medical or healthcare professionals only:
Instructions for use ? preparation, handling and disposal
Appropriate procedures for proper handling and disposal of cytotoxic medicines must be followed. Any unused medicine or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.
You should have received training on the correct techniques to reconstitute and dilute Yondelis or its combination with PLD and you should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution. Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water. You should not work with this medicine if you are pregnant.
Preparation for intravenous infusion:
Yondelis must be reconstituted and further diluted prior to infusion (see also section 3). Appropriate aseptic techniques must be used.
Yondelis must not be administered as a mixture with other medicines in the same infusion apart from the diluent. 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.
When Yondelis is 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 may cause precipitation of PLD. (See also PLD Summary Products Characteristics for specific handling instructions).
Instructions for reconstitution:
Yondelis 0.25 mg: Inject 5 ml of sterile water for injections into the vial.
Yondelis 1 mg: Inject 20 ml of sterile water for injections into the vial.
A syringe is used to inject the correct amount of sterile water for injections into the vial. Shake the vial 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:
Dilute the reconstituted solution with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion. Calculate the required volume as follows:
Volume ml BSA m2 x individual dose mgm2 0.05 mgml
BSA = Body Surface Area
Withdraw the appropriate amount of reconstituted solution from the vial. If administration is to be made via a central venous line, add the reconstituted solution 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, add the reconstituted solution 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).
Inspect the parenteral solution visually for particles prior to administration. Once the infusion is prepared, it should be administered immediately.
In-use stability of the solutions:
Reconstituted solution: After reconstitution, chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
From a microbiological point of view, the reconstituted solution should be diluted and used immediately. If not diluted and used immediately, in-use storage times and conditions prior to use of the reconstituted solution are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Diluted solution: After dilution, chemical and physical stability has been demonstrated for 30 hours up to 25ºC.