Trabectedin: uses, dosing, side effects & brands
Trabectedin is an alkylating drug sold in the U.S. under 2 brand and generic names, for leiomyosarcoma and liposarcoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Alkylating Drug
- Treats
- Leiomyosarcoma and Liposarcoma
- Available as
- Injectable
- Sold as
- 2 products — Evdi and Yondelis
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How trabectedin is dosed
From the FDA label for Evdi (application NDA220837). Other trabectedin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer at 1.5 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line ( 2.1 , 2.5 ) Premedication: dexamethasone 20 mg intravenously, 30 min before each infusion ( 2.2 ) Hepatic Impairment: Administer at 0.9 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line in patients with moderate hepatic impairment ( 2.1 ) 2.1 Recommended Dosage The recommended dose is 1.5 mg/m 2 administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks), until disease progression or unacceptable toxicity. 2.2 Recommended Dosage in Patients with Hepatic Impairment The recommended dosage of EVDI in patients with moderate hepatic impairment (bilirubin levels greater than 1.5 times to 3 times the upper limit of normal, and AST and ALT less than 8 times the upper limit of normal) is 0.9 mg/m 2 every 21 days (3 weeks). Do not administer EVDI to patients with severe hepatic impairment (bilirubin levels above 3 times the upper limit of normal, and any AST and ALT) [see Use in Specific Populations (8.6) and Clinical Pharmacology ( 12.3 )]. 2.3 Premedication Administer dexamethasone 20 mg intravenously 30 minutes prior to each dose of EVDI. 2.4 Dosage Modifications for Adverse Reactions Permanently discontinue EVDI for: Persistent adverse reactions requiring a delay in dosing of more than 3 weeks.…
Trabectedin side effects
The following adverse reactions are discussed in more detail in other sections of the labeling: Anaphylaxis [see Contraindications (4) ] Neutropenic Sepsis [see Warnings and Precautions (5.1) ] Rhabdomyolysis [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Cardiomyopathy [see Warnings and Precautions (5.4) ] Capillary Leak Syndrome [see Warnings and Precautions (5.5) ] Extravasation Resulting in Tissue Necrosis [see Warnings and Precautions (5.6) ] The most common (≥20%) adverse reactions are nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache. The most common (≥5%) grades 3 to 4 laboratory abnormalities are: neutropenia, increased ALT, thrombocytopenia, anemia, increased AST, and increased creatine phosphokinase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to trabectedin in 755 patients with soft tissue sarcoma including 197 (26%) patients exposed to…
Who shouldn’t take trabectedin
EVDI is contraindicated in patients with known severe hypersensitivity, including anaphylaxis, to trabectedin. Known hypersensitivity to trabectedin ( 4 )
Trabectedin drug interactions
CYP3A inhibitors: Avoid concomitant strong CYP3A inhibitors ( 7.1 ) CYP3A inducers: Avoid concomitant strong CYP3A inducers ( 7.1 ) 7.1 Effects of Other Drugs on EVDI Table 5 describes drug interactions where concomitant use of another drug affects EVDI. Table 5: Drug Interactions with EVDI Strong CYP3A Inhibitors Prevention or Management Avoid concomitant use of strong CYP3A inhibitors in patients taking EVDI. If concomitant use of a strong CYP3A inhibitor for short-term use (i.e., less than 14 days) cannot be avoided, administer the strong CYP3A inhibitor 1 week after the EVDI infusion, and discontinue it the day prior to the next EVDI infusion Mechanism and Clinical Effect(s) Concomitant administration of trabectedin with ketoconazole, a strong CYP3A inhibitor, increased systemic exposure of trabectedin by 66% [see Clinical Pharmacology ( 12.3 )]. Strong CYP3A Inducers Prevention or Management Avoid concomitant use of strong CYP3A inducers in patients taking EVDI. Mechanism and Clinical Effect(s) Concomitant administration of trabectedin with rifampin, a strong CYP3A4 inducer, decreased systemic exposure of trabectedin by 31% [see Clinical Pharmacology ( 12.3 )]. Drug Interactions Effect of Strong CYP3A Inhibitors on Trabectedin Coadministration of multiple doses of ketoconazole (200 mg twice daily for 7.5 days) with a single dose of EVDI (0.58 mg/m 2 ) on day 1 increased trabectedin dose-normalized AUC by 66% and C max by 22% compared to a single EVDI dose (1.3 mg/m 2 ) given alone. Effect of Strong CYP3A Inducers on Trabectedin Coadministration of multiple doses of rifampin (600 mg daily for 6 days) with a single EVDI dose (1.3 mg/m 2 ) on day 6 decreased trabectedin AUC by 31% and C max by 21% compared to a single EVDI dose (1.3 mg/m 2 ) given alone. Effect of Trabectedin on CYP Enzymes In vitro , trabectedin has limited inhibition or induction potential of major CYP enzymes (CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, and 3A4).
Every trabectedin product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 66/100 | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
What people report to the FDA about trabectedin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,151 reports naming trabectedin, and the FDA flagged 98% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- neutropenia154 reports
- anaemia130 reports
- thrombocytopenia130 reports
- febrile neutropenia106 reports
- nausea103 reports
- vomiting91 reports
- asthenia70 reports
- fatigue65 reports
Read these as a signal, not a rate. A report does not mean trabectedin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is trabectedin?
Evdi (Trabectedin) is an alkylating drug used to treat Leiomyosarcoma, Liposarcoma.
What kind of drug is trabectedin?
The FDA classifies trabectedin as an alkylating drug. Alkylating chemotherapy drugs attach chemical groups to a cell's DNA, forming cross-links that lock the two DNA strands together. This damage stops the cell from copying its DNA and dividing, which triggers it to die; because they are not limited to one phase of the cell cycle, they can act on cells whether or not they are actively dividing. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take trabectedin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run trabectedin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is trabectedin sold under?
We track 2 trabectedin-containing products in the U.S.: Evdi and Yondelis. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does trabectedin come in?
Across the brands we track, trabectedin is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic trabectedin?
We do not currently list a generic-labelled trabectedin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Trabectedin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/trabectedin
- MLA
- “Trabectedin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/trabectedin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for trabectedin on DailyMed (NIH) ↗.