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Trabectedin

Yondelis · ATC code L01CX01

Also known as: Trabektedin · Brand names: Yondelis, Trabectedin Ever Pharma, Trabectedin Stada, Trabectedin Sun, Trabectedin Teva, Trabectedin Ratiopharm, Yolisar

Key facts
Active substance
Trabectedin
ATC code
L01CX01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Yondelis 0.25 mg powder for concentrate for solution for infusion. / Yondelis 1 mg powder for concentrate for solution for infusion.
Marketing authorisation holder
Pharma Mar S.A.
Information as of
2026-10-28

Key facts

Trabectedin is a cytotoxic anticancer medicine given by intravenous infusion. It is used in advanced soft tissue sarcoma and, with pegylated liposomal doxorubicin, in relapsed platinum-sensitive ovarian cancer.

What it is used for

  • Adults with advanced soft tissue sarcoma after failure of anthracyclines and ifosfamide, or unsuited to receive these; efficacy data are based mainly on liposarcoma and leiomyosarcoma (Yondelis).
  • With pegylated liposomal doxorubicin (PLD): relapsed platinum-sensitive ovarian cancer.

Dosing

  • Soft tissue sarcoma: 1.5 mg/m2 body surface area as an intravenous infusion over 24 hours, every three weeks.
  • Ovarian cancer: 1.1 mg/m2 as a 3-hour infusion every three weeks, immediately after PLD 30 mg/m2.
  • All patients receive a corticosteroid 30 minutes beforehand, e.g. 20 mg dexamethasone intravenously. Administration through a central venous line is strongly recommended.
  • Criteria include: neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ ULN, albumin ≥ 25 g/l, CPK ≤ 2.5 x ULN, creatinine clearance ≥ 30 ml/min (monotherapy) or ≥ 60 ml/min (combination).
  • Reduce the dose one level after severe toxicities; check blood counts and liver tests weekly in the first two cycles. See the full text for details.

Contraindications

  • Hypersensitivity to trabectedin or any of the excipients.
  • Concurrent serious or uncontrolled infection.
  • Breast-feeding.
  • Combination with yellow fever vaccine.

Important warnings

  • Hepatic impairment increases exposure; do not treat patients with elevated bilirubin.
  • Do not use with creatinine clearance < 30 ml/min (monotherapy) or < 60 ml/min (combination).
  • Grade 3 or 4 neutropenia and thrombocytopenia are very common; seek prompt medical attention for fever.
  • Rhabdomyolysis and severe CPK elevations; do not use with CPK > 2.5 x ULN.
  • Potentially severe injection site reactions with peripheral administration; monitor cardiac function.

Side effects

  • Adverse reactions of any grade in 91% (monotherapy) and 99.4% (combination).
  • Most common: neutropenia, nausea, vomiting, AST/ALT increase, anaemia, fatigue, thrombocytopenia, anorexia and diarrhoea.
  • Fatal adverse reactions in 1.9% and 0.6%, often from pancytopenia, febrile neutropenia with sepsis, hepatic, renal or multiorgan failure and rhabdomyolysis.

Interactions

  • Mainly metabolised by CYP3A4: potent inhibitors (e.g. ketoconazole) may raise levels and potent inducers (e.g. rifampicin) lower them. See the full text for more.

Pregnancy and breastfeeding

  • May cause serious birth defects; should not be used during pregnancy. For contraception see the full text.
  • Breast-feeding is contraindicated.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Trabectedin Ever PharmaEver Valinject Gmbh · 1 register entry
  • Trabectedin StadaStada Arzneimittel Gmbh · 1 register entry
  • Trabectedin SunSun Pharmaceutical Industries Europe B.V. · 2 register entries
  • Trabectedin TevaTeva B.V · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Trabectedin Ever PharmaEver Valinject Gmbh · 1 register entry
  • Trabectedin RatiopharmRatiopharm Gmbh · 1 register entry
  • Trabectedin StadaStadapharm Gmbh · 1 register entry
  • Trabectedin SunSun Pharmaceuticals Germany Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • YolisarVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • YondelisONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 26 more European countries
Belgium
Trabectedin Eg (Eurogenerics), Trabectedin Ever Pharma, Trabectedine Eg (Eurogenerics), Trabectedine Ever Pharma, Trabectedine Sun, Trabectedine Teva
Bulgaria
Трабектедин Ever Pharma
Croatia
Trabektedin Ever Pharma, Trabektedin Teva
Czechia
Trabectedin Ever Pharma
Denmark
Trabectedin Teva, Trabektedin
Estonia
Trabectedin Ever Pharma
Finland
Trabectedin
France
Trabectedin, Trabectedine Eg, Trabectedine Sun, Trabectedine Teva
Greece
Trabectedin Ever Pharma, Trabectedin Teva
Hungary
Trabectedin
Iceland
Trabectedin Accord, Yondelis
Ireland
Trabectedin Ever Pharma
Italy
Trabectedina Eg Spa, Trabectedina Ever Pharma, Trabectedina Sun, Trabectedina Teva
Latvia
Trabectedin Ever Pharma
Liechtenstein
Trabectedin Accord, Yondelis
Lithuania
Trabectedin Ever Pharma
Luxembourg
Trabectedin Eg (Eurogenerics) Nv, Trabectedine Teva
Netherlands
Trabectedine Ever Pharma, Trabectedine Teva
Norway
Trabectedin, Yondelis
Poland
Trabectedin Ever Pharma
Portugal
Trabectedina Ever Pharma, Trabectedina Teva
Romania
Trabectedin Ever Pharma, Trabectedin Teva, Trabectedină
Slovakia
Trabectedin Ever Pharma, Trabectedin Teva
Slovenia
Trabektedin Ever Pharma, Trabektedin Teva
Spain
Trabectedina
Sweden
Trabectedin Ever Pharma, Trabectedin Stada, Trabectedin Teva, Trabektedin Sun

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Yondelis – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/yondelis-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.