YONDELIS Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Yondelis 0.25 mg powder for concentrate for solution for infusion. Yondelis 1 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Yondelis 0.25 mg: Each vial of powder contains 0.25 mg of trabectedin. One ml of reconstituted solution contains 0.05 mg of trabectedin. Excipients with known effect: Each vial of powder contains 2 mg ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white powder.
Therapeutic indications
Yondelis is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are ...
Posology and method of administration
Yondelis must be administered under the supervision of a physician experienced in the use of chemotherapy. Its use should be confined to qualified oncologists or other health professionals specialised ...
Contraindications
Hypersensitivity to trabectedin or to any of the excipients listed in section 6.1. Concurrent serious or uncontrolled infection. Breast-feeding (see section 4.6). Combination with yellow fever vaccine ...
Special warnings and precautions for use
Hepatic impairment Patients must meet specific criteria on hepatic function parameters to start treatment with Yondelis. Since the systemic exposure to trabectedin is on average approximately doubled (see ...
Interaction with other medicinal products and other forms of interaction
Effects of other substances on trabectedin Interaction studies have only been performed in adults. Since trabectedin is metabolised mainly by CYP3A4, the concentrations of trabectedin in plasma are likely ...
Fertility, pregnancy and lactation
Pregnancy No sufficient clinical data on exposed pregnancies are available. However, based on its known mechanism of action, trabectedin may cause serious birth defects when administered during pregnancy. ...
Effects on ability to drive and use machines
No studies on the effects of the ability to drive and to use machines have been performed. However, fatigue and/or asthenia have been reported in patients receiving trabectedin. Patients who experience ...
Undesirable effects
Summary of the safety profile Most patients treated with Yondelis can be expected to have adverse reactions of any grade (91% in monotherapy and 99% in combination therapy) and less than one third serious ...
Overdose
There is limited data on the effects of trabectedin overdose. The major anticipated toxicities are gastrointestinal, bone marrow suppression and hepatic toxicity. There is no specific antidote for trabectedin ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agent ATC code: L01CX01 Mechanism of action Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove. This binding ...
Pharmacokinetic properties
Distribution Systemic exposure after intravenous administration as a constant rate infusion is dose proportional at doses up to and including 1.8 mg/m². Trabectedin pharmacokinetic profile is consistent ...
Preclinical safety data
Preclinical data indicate that trabectedin has limited effect on the cardiovascular, respiratory and central nervous system at exposures below the therapeutic clinical range, in terms of AUC. The effects ...
List of excipients
Sucrose Potassium dihydrogen phosphate Phosphoric acid (for pH-adjustment) Potassium hydroxide (for pH-adjustment)
Incompatibilities
Yondelis must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vials: 60 months. After reconstitution: Chemical and physical stability has been demonstrated for 30 hours up to 25°C. From a microbiological point of view, the reconstituted solution ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Nature and contents of container
Yondelis 0.25 mg: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 0.25 mg of trabectedin. Each carton contains one vial. Yondelis 1 mg: Type ...
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 ...
Marketing authorization holder
Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770, Colmenar Viejo (Madrid), Spain
Marketing authorization number(s)
Yondelis 0.25 mg: EU/1/07/417/001 Yondelis 1 mg: EU/1/07/417/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 September 2007 Date of latest renewal: 03 August 2012
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