Marine-derived alkylating cytotoxic Pregnancy: No sufficient clinical data on exposed pregnancies are available; based on its known mechanism of action trabectedin may cause serious birth defects and should not be used during pregnancy. Women of childbearing potential must use highly effective contraception during treatment and for 8 months thereafter; men in fertile age must use highly effective contraception during treatment and for 5 months after. Breast-feeding is contraindicated during treatment and for 3 months thereafter. Advice on conservation of ova or sperm should be sought before treatment because of the possibility of irreversible infertility.

Trabectedin (Specialist drug)

Brand names: Yondelis

Trabectedin is a marine-derived alkylating cytotoxic agent used under specialist supervision for advanced soft-tissue sarcoma and relapsed platinum-sensitive ovarian cancer.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Soft tissue sarcoma: 1.5 mg/m2 body surface area

Route: Intravenous infusion over 24 hours; administration through a central venous line is strongly recommended

Frequency: Every three weeks (three-week interval between cycles)

Must be administered under the supervision of a physician experienced in the use of chemotherapy; use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic agents. Ovarian cancer: 1.1 mg/m2 given every three weeks as a 3-hour infusion, immediately after pegylated liposomal doxorubicin (PLD) 30 mg/m2 — to minimise the risk of PLD infusion reactions the initial PLD dose is given at a rate no greater than 1 mg/minute, and if no infusion reaction occurs subsequent PLD infusions may be given over 1 hour. All patients must receive corticosteroids, e.g. dexamethasone 20 mg intravenously 30 minutes before PLD (combination therapy) or before trabectedin (monotherapy), both as anti-emetic prophylaxis and for apparent hepatoprotective effect. Treatment criteria required before each course: ANC at least 1,500/mm3; platelets at least 100,000/mm3; bilirubin at or below ULN; alkaline phosphatase at or below 2.5 x ULN; albumin at least 25 g/l; ALT and AST at or below 2.5 x ULN; creatinine clearance at least 30 ml/min (monotherapy) or serum creatinine 1.5 mg/dl or less (132.6 micromol/l) or creatinine clearance at least 60 ml/min (combination); CPK at or below 2.5 x ULN; haemoglobin at least 9 g/dl. If criteria are not met, delay treatment for up to 3 weeks. Dose reduction (one level for defined toxicities, no re-escalation afterwards): soft tissue sarcoma 1.5 to 1.2 to 1.0 mg/m2; ovarian cancer trabectedin 1.1 to 0.9 to 0.75 mg/m2 with PLD 30 to 25 to 20 mg/m2; consider discontinuation if further reductions are needed. Duration: no pre-defined limit to the number of cycles in clinical trials; treatment continued while clinical benefit was noted. Elderly: dose adjustments based uniquely on age are not routinely recommended. Hepatic impairment: special caution and dose adjustment may be necessary; patients with elevated serum bilirubin at baseline must not be treated. Paediatric population: trabectedin should not be used in children below 18 years with paediatric sarcomas because of efficacy concerns.

Dose adjustments

Renal

Studies in patients with renal insufficiency (creatinine clearance below 30 ml/min for monotherapy, and below 60 ml/min for the combination regimen) have not been conducted and trabectedin must not be used in this population. Considering its pharmacokinetics, no dose adjustments are warranted in patients with mild or moderate renal impairment. Creatinine clearance must be monitored prior to and during treatment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

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

Side effects

Very common: neutropenia, thrombocytopenia, anaemia, leukopenia; common febrile neutropenia and neutropenic infection; sepsis and septic shock reported
Very common: nausea, vomiting, constipation, diarrhoea, abdominal pain, decreased appetite; common stomatitis and dyspepsia
Very common: increases in ALT, AST, blood alkaline phosphatase, blood bilirubin and gamma-glutamyltransferase; hepatic failure reported
Very common: fatigue, pyrexia, oedema; common headache, dizziness, back pain, myalgia and arthralgia
Blood creatine phosphokinase increased (very common) with uncommon rhabdomyolysis, usually in association with myelotoxicity, severe liver function abnormalities and/or renal or multiorgan failure; injection site reactions, extravasation and soft tissue necrosis reported

Interactions

Yellow fever vaccine — combination is contraindicated (SPC §4.3)
Medicinal products associated with rhabdomyolysis, e.g. statins — caution if given concomitantly, since the risk of rhabdomyolysis may be increased (SPC §4.4). Note: the SPC §4.5 interaction section was not retrieved in the fetched bundle and must be checked in full by the reviewing clinician

Clinical monograph

How it works

It binds the minor groove of DNA, bending the helix and interfering with transcription, DNA repair and the cell cycle, ultimately triggering cell death.

Prescribing in practice

Administer only via a central venous line because extravasation causes severe tissue necrosis, and give with corticosteroid premedication to reduce hepatotoxicity and emesis.
It is a specialist chemotherapy agent restricted to clinicians experienced in cytotoxic therapy.
Hepatic impairment and concomitant CYP3A4 inhibitors increase toxicity and require careful review against the SPC.

Monitoring

Monitor full blood count, liver function and creatine kinase before each cycle and intermittently during treatment.

Counselling the patient

Report fever, unusual bruising or bleeding, or dark urine and muscle pain promptly.
Effective contraception is required during and for a period after treatment.
Injection-site or infusion reactions should be flagged to the team immediately.

Evidence & guidelines

Use is guided by the SPC and NICE technology appraisals for soft-tissue sarcoma and ovarian cancer.

Reference: NICE TA185/TA389; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways