• Bone and connective tissue cancer

Yondelis Generic Name & Formulations

General Description

Trabectedin 1mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains sucrose.

Pharmacological Class

Alkylating agent.

How Supplied

Single-dose vial—1

Generic Availability


Yondelis Indications


Treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients who have received prior anthracycline-containing regimen.

Yondelis Dosage and Administration


Premedicate 30mins prior to each dose with IV dexamethasone 20mg. Give by IV infusion over 24hrs. 1.5mg/m2 every 21 days until disease progression or unacceptable toxicity. Moderate hepatic impairment: 0.9mg/m2 every 21 days. Dose modifications for adverse reactions: see full labeling. Do not increase dose in subsequent cycles once reduced.


<18yrs: not established.

Yondelis Contraindications

Not Applicable

Yondelis Boxed Warnings

Not Applicable

Yondelis Warnings/Precautions


Assess neutrophil count prior to each dose and periodically during the cycle; withhold or reduce dose based on severity of reaction. Assess CPK levels prior to each dose; withhold, reduce dose, or permanently discontinue based on severity of reaction. Assess LFTs prior to each dose and as indicated based on pre-existing hepatic impairment; interrupt, reduce dose, or permanently discontinue based on severity/duration of abnormality. Increased risk of cardiac dysfunction (patients with LVEF <LLN, prior cumulative anthracycline ≥300mg/m2, age ≥65yrs, history of cardiac disease). Assess LVEF by ECHO or MUGA scan prior to initiation and every 2–3 months thereafter until discontinued; permanently discontinue based on severity of reaction. Monitor for capillary leak syndrome; discontinue and treat promptly if occurs. Severe hepatic impairment: not recommended. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) or 5 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.

Yondelis Pharmacokinetics

See Literature

Yondelis Interactions


Avoid concomitant strong CYP3A inhibitors (eg, oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan), grapefruit or grapefruit juice; if short-term use (<14 days) necessary, give inhibitor 1 week after infusion and discontinue the day prior to next infusion. Avoid concomitant strong CYP3A inducers (eg, rifampin, phenobarbital, St. John’s wort).

Yondelis Adverse Reactions

Adverse Reactions

Nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, headache, neutropenia, increased ALT, thrombocytopenia, anemia, increased AST and CPK; anaphylaxis, neutropenic sepsis, rhabdomyolysis, hepatotoxicity, cardiomyopathy, capillary leak syndrome, extravasation resulting in tissue necrosis, infertility.

Yondelis Clinical Trials

See Literature

Yondelis Note

Not Applicable

Yondelis Patient Counseling

See Literature