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Yondelis 1mg Vial
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Indications & Clinical Uses
- Yondelis 1 mg (trabectedin) is a cytotoxic anticancer medicine supplied as a freeze-dried powder in a single-dose vial and given only by a healthcare provider in hospital.
- In the US it is approved for adults with unresectable or metastatic liposarcoma or leiomyosarcoma who have already received an anthracycline-containing regimen, as a 24-hour intravenous infusion through a central venous line every 3 weeks at 1.5 mg/m2.
- In the EU (marketing authorisation holder PharmaMar) it is authorised for advanced soft-tissue sarcoma after anthracycline and ifosfamide have failed, and, together with pegylated liposomal doxorubicin, for relapsed platinum-sensitive ovarian cancer (1.1 mg/m2 over 3 hours).
- Yondelis is not indicated for gastrointestinal stromal tumours (GIST).
- It remains FDA-approved and marketed, with US labelling last updated in January 2026.
Side Effects
- Very common effects in the US label (20% or more of patients) were nausea (75%), tiredness (69%), vomiting (46%), constipation (37%), reduced appetite (37%), diarrhoea (35%), swelling of the legs (28%), breathlessness (25%) and headache (25%).
- Grade 3 to 4 laboratory changes included low neutrophils (43%), raised ALT (31%), low platelets (21%), anaemia (19%) and raised CPK (6%).
- Serious reactions include neutropenic sepsis (fatal in 1.1%), rhabdomyolysis (muscle breakdown; fatal in 0.8%), liver damage, cardiomyopathy (6%; fatal in 0.3%), capillary leak syndrome, and tissue damage if the infusion leaks outside the vein.
- Yondelis has no boxed warning.
- Report fever, muscle pain or weakness, breathlessness, swelling, or pain or redness at the infusion site straight away.
Precautions & Warnings
- Yondelis must not be given to anyone with known severe hypersensitivity, including anaphylaxis, to trabectedin; the EU information also contraindicates it in serious or uncontrolled infection.
- Dexamethasone 20 mg IV is given 30 minutes before each infusion.
- It is infused through a central venous line.
- Liver tests and CPK are checked before each dose, heart function (LVEF by echocardiogram or MUGA) before starting and every 2 to 3 months, and treatment is withheld or reduced if neutrophils fall below 1,500 per microlitre.
- Dose is reduced to 0.9 mg/m2 in moderate liver impairment.
- It can cause fetal harm: women should use effective contraception during treatment and for 8 months after, and men with female partners for 5 months.
- Do not breastfeed during treatment or for 3 months after the last dose.
Avoid Interactions
- Increase toxicity: strong CYP3A inhibitors such as ketoconazole (raised trabectedin exposure by 66%) should be avoided.
- Reduce efficacy: strong CYP3A inducers such as rifampin (lowered exposure by 31%) should be avoided.
- The EU information advises avoiding yellow fever vaccine during treatment (live vaccines are risky when the immune system is weakened).
- Corticosteroid premedication is part of the regimen and is given by your care team.
- Tell your healthcare provider about all prescription, over-the-counter and herbal medicines and supplements before every treatment cycle, and mention any new medicine started between cycles, because some antifungals and antibiotics affect the same liver enzyme.
References
Frequently Asked Questions
Yondelis (trabectedin) treats certain soft-tissue sarcomas. In the US it is for liposarcoma or leiomyosarcoma that cannot be removed or has spread, after an anthracycline. In the EU it is also used with pegylated liposomal doxorubicin for relapsed platinum-sensitive ovarian cancer. It is not approved for GIST.
Yondelis (trabectedin) is given in hospital by a healthcare provider as an intravenous infusion through a central venous line. In the US the dose is 1.5 mg/m2 over 24 hours every 3 weeks. You receive dexamethasone 20 mg intravenously 30 minutes before each infusion.
Very common Yondelis side effects include nausea, tiredness, vomiting, constipation, poor appetite, diarrhoea, leg swelling, breathlessness and headache. Serious risks are infection with low neutrophils, muscle breakdown, liver injury, heart muscle weakness and tissue damage if it leaks. Report fever, muscle pain or breathlessness immediately.
Avoid strong CYP3A inhibitors such as ketoconazole and strong inducers such as rifampin with Yondelis (trabectedin), because they change its levels. Avoid yellow fever vaccine during treatment. Do not breastfeed during treatment or for 3 months after your last dose.
Yondelis (trabectedin) requires liver function tests and CPK before every dose, and neutrophil counts, which must be at least 1,500 per microlitre. Heart function (LVEF) is checked by echocardiogram or MUGA scan before treatment and every 2 to 3 months. Doses are withheld or reduced if results are abnormal.
Yondelis (trabectedin) can harm an unborn baby. Women should use effective contraception during treatment and for 8 months after the last dose. Men with female partners should use contraception during treatment and for 5 months after. Tell your healthcare provider immediately if pregnancy occurs.
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