Yondelis Generic Name & Formulations
Trabectedin 1mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains sucrose.
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 Boxed Warnings
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.
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
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
Yondelis Patient Counseling