Trabectedin Injection
Trabectedin Injection is an intravenous (IV) chemotherapy medicine used to treat certain advanced soft tissue sarcomas, specifically liposarcoma and leiomyosarcoma, after earlier treatment with an anthracycline.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Trabectedin (Yondelis) is a specialist IV chemotherapy, on the U.S. market since about 2015, for liposarcoma or leiomyosarcoma that cannot be removed by surgery or has spread, once an anthracycline such as doxorubicin has been tried; it binds and bends DNA so cancer cells cannot copy or repair it. It is a demanding treatment, with nausea, vomiting, tiredness and leg swelling most common. Serious infection, liver injury, muscle breakdown and heart damage are the real risks, so report fever, muscle pain or dark urine, swelling, or breathing or heart symptoms right away. Blood counts, liver tests and muscle enzymes are checked before every dose, and your heart is checked regularly.
Clinical pearls
- It runs through a central line in a large vein, and leaks can damage tissue, so report site pain or redness.
- Avoid drugs that strongly block the liver enzyme CYP3A, like ketoconazole, or speed it up, like rifampin.
- Moderate liver problems mean a lower dose and severe liver problems rule it out, so share any liver history first.
- It can harm a pregnancy, so use contraception during treatment and for at least 8 months after (5 for men with female partners).
Patient information guide A plain-language walkthrough of Trabectedin Injection, written from its FDA label.
What Trabectedin Injection is used for
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Trabectedin Injection is a chemotherapy given into a vein for certain soft tissue cancers.
- Yondelis is used in adults with unresectable or metastatic liposarcoma.
- Yondelis is used in adults with unresectable or metastatic leiomyosarcoma.
- Both uses are for people who already received a chemotherapy regimen containing an anthracycline.
How Trabectedin Injection works
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Trabectedin is an alkylating drug. It binds to DNA and bends it, which disrupts proteins and repair pathways that cells depend on. This upsets the cell cycle and eventually leads to cell death.
Trabectedin Injection dosage
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Trabectedin is given by a healthcare professional as an IV infusion through a central line. Yondelis runs over 24 hours, once every 3 weeks, until the cancer progresses or side effects become unacceptable.
- A steroid (dexamethasone) is given through the IV about 30 minutes before each infusion.
- Doses may be delayed or lowered based on blood counts, liver tests and side effects.
- Dose is lower for moderate liver impairment.
Because your team gives each dose, missed-dose rules are handled by them. Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Trabectedin Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (normal hepatic function or mild hepatic impairment)
- 1.5 mg/m2 administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks), until disease progression or unacceptable toxicity
- Premedicate with dexamethasone 20 mg intravenously 30 minutes prior to each dose
- Dose reductions: first 1.2 mg/m2, second 1.0 mg/m2; once reduced, do not increase in subsequent cycles
- Moderate hepatic impairment (bilirubin 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)
- 0.9 mg/m2 every 21 days (3 weeks) as a 24-hour intravenous infusion through a central venous line
- Premedicate with dexamethasone 20 mg intravenously 30 minutes prior to each dose
- Dose reductions: first 0.6 mg/m2, second 0.3 mg/m2
- Severe hepatic impairment (bilirubin above 3 times the upper limit of normal, and any AST and ALT)
- Do not administer YONDELIS
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administer at 1.5 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line ( 2.1 , 2.6 ) Premedication: dexamethasone 20 mg intravenously, 30 min before each infusion ( 2.3 ) 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 ( 2.2 ) 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 YONDELIS 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 YONDELIS 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 YONDELIS. 2.4 Dosage Modifications for Adverse Reactions Permanently discontinue YONDELIS for: Persistent adverse reactions requiring a delay in dosing of more than 3 weeks. Adverse reactions requiring dose reduction following YONDELIS administered at 1.0 mg/m 2 for patients with normal hepatic function or at 0.3 mg/m 2 for patients with pre-existing moderate hepatic impairment. Severe liver dysfunction: bilirubin two times the upper limit of normal, and AST or ALT three times the upper limit of normal, and alkaline phosphatase less than two times the upper limit of normal in the prior treatment cycle for patients with normal liver function at baseline. Exacerbation of liver dysfunction in patients with pre-existing moderate hepatic impairment. Capillary leak syndrome. Rhabdomyolysis. Grade 3 or 4 cardiac adverse events (AEs) indicative of cardiomyopathy or for subjects with an LVEF that decreases below the lower limit of normal. The recommended dose modifications for adverse reactions are listed in Table 1. Once reduced, the dose of YONDELIS should not be increased in subsequent treatment cycles.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Trabectedin Injection side effects
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The most common side effects in studies were:
Common side effects
- Nausea
- Vomiting
- Fatigue
- Constipation
- Diarrhea
- Decreased appetite
- Swelling in the arms or legs (peripheral edema)
- Shortness of breath and headache
When to get medical help
- Fever, chills or signs of infection: severe and sometimes fatal infection with very low white blood cells (neutropenic sepsis) can occur.
- Muscle pain, weakness or dark urine: this can signal rhabdomyolysis (muscle breakdown), which can lead to kidney failure.
- Swelling, shortness of breath, or new or worsening heart symptoms: serious heart muscle problems (cardiomyopathy) can occur.
- Low blood pressure with swelling: this can signal capillary leak syndrome, which can be fatal.
- Pain, redness or swelling at the IV site: the drug leaking out of the vein can cause tissue damage.
- Signs of liver problems: liver injury, including liver failure, can occur.
Common lab changes include low white blood cells, low platelets, anemia, and raised liver and muscle enzymes. Contact your care team promptly about fever, muscle pain, heart symptoms, swelling or IV site pain.
Trabectedin Injection warnings and precautions
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- Neutropenic sepsis: severe and sometimes fatal infection with low white blood cells. Neutrophil counts are monitored before each dose.
- Rhabdomyolysis: muscle breakdown that can cause kidney failure. CPK is checked before each dose.
- Liver injury: including liver failure. Liver tests are checked before each dose.
- Cardiomyopathy: severe and sometimes fatal heart muscle disease. Heart function is checked before treatment and every 2 to 3 months.
- Capillary leak syndrome: low blood pressure, swelling and low albumin, which can be fatal.
- Extravasation: leakage from the vein can cause tissue death needing surgery, and signs can appear more than a week later.
- Embryo-fetal toxicity: can harm an unborn baby.
Trabectedin Injection interactions
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Drugs that affect the CYP3A liver enzyme can change trabectedin levels.
- Strong CYP3A inhibitors, such as ketoconazole, raised trabectedin exposure by 66%. Avoid them.
- Strong CYP3A inducers, such as rifampin, lowered exposure by 31%. Avoid them.
- If a strong inhibitor is needed short-term (under 14 days), timing around the infusion must be managed by your team.
Interactions listed in the FDA-approved label
From the Trabectedin Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A inhibitors: Concomitant administration of trabectedin with ketoconazole, a strong CYP3A inhibitor, increased systemic exposure of trabectedin by 66%. Avoid concomitant use. If short-term use (less than 14 days) cannot be avoided, administer the strong CYP3A inhibitor 1 week after the infusion, and discontinue it the day prior to the next infusion.
- Strong CYP3A inducers: Concomitant administration of trabectedin with rifampin, a strong CYP3A4 inducer, decreased systemic exposure of trabectedin by 31%. Avoid concomitant use of strong CYP3A inducers.
- CYP enzymes (CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, and 3A4): In vitro, trabectedin has limited inhibition or induction potential of major CYP enzymes.
Read the label’s full interactions text
7 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).
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Trabectedin Injection
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- Do not use with a known severe allergy, including anaphylaxis, to trabectedin.
- Severe liver impairment: Yondelis should not be given. Moderate impairment needs a lower dose.
- Heart disease, low LVEF, prior high anthracycline exposure or age 65 or older raise heart risk.
- Pregnancy: can cause fetal harm, and pregnancy status is checked first.
- Use effective contraception: females for at least 8 months after the last dose, males for at least 5 months.
- Do not breastfeed during treatment and for 3 months after the last dose.
- May reduce fertility in men and women.
- Children: safety and effectiveness have not been established.
Trabectedin Injection overdose
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There is no specific antidote for Yondelis. Dialysis is not expected to help remove it, because the drug is highly bound to proteins in the blood and is not cleared much by the kidneys.
What Trabectedin Injection does in the body
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In a study of 75 patients, trabectedin given as a 3-hour infusion did not cause large changes in the QT interval, a measure of the heart's electrical timing. No patient had a QTc above 500 msec or a rise of more than 60 msec from baseline.
How your body processes Trabectedin Injection
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After an infusion, trabectedin levels drop quickly at first and then more slowly. The terminal half-life is about 175 hours. It is about 97% bound to blood proteins.
The liver breaks it down, mainly with the CYP3A enzyme. Most of it leaves the body in stool (about 58%) rather than urine (about 6%). It does not build up with doses every 3 weeks. Moderate liver impairment roughly doubled exposure.
How to store Trabectedin Injection
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Store EVDI vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Trabectedin Injection
156 supplements and herbal products have documented interactions with Trabectedin Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 122
- Minor · 29
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Trabectedin Injection has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Trabectedin Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Trabectedin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How will I get it?
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What side effects should I expect?
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When should I call my care team right away?
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Do I need blood tests or heart checks?
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Can I take other medicines or get pregnant while on it?
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Is Trabectedin Injection available over the counter?
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When was Trabectedin Injection first available?
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Who makes Trabectedin Injection?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Trabectedin Injection on HelloPharmacist
Trabectedin Injection forms and strengths (how it comes)
Trabectedin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Yondelis is used for adults with unresectable or metastatic liposarcoma or leiomyosarcoma who previously received an anthracycline-containing regimen.
- Yondelis is given as a 24-hour IV infusion through a central venous line, every 3 weeks.
- Yondelis is preceded by IV dexamethasone about 30 minutes before each dose.
- Yondelis is a hazardous drug that must be prepared and diluted by trained staff using special handling.
- Evdi: avoid strong CYP3A inhibitors and inducers while receiving it.
Trabectedin Injection on the U.S. market: products, makers and brands
How Trabectedin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 2 Trabectedin Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2015. Brand names on the directory include Yondelis, Evdi; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Trabectedin Injection is used (Medicaid data)
A general measure of how commonly Trabectedin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Trabectedin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Trabectedin Injection prescribed? Of the 1,601 medications we measure, Trabectedin Injection ranks #1,343 by Medicaid prescriptions — more than 16% of them.
Utilization by Trabectedin Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
trabectedin 1 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1718589
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Trabectedin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Trabectedin Injection NDCs with Medicaid activity.
Compare Trabectedin Injection products
A representative set of FDA-listed product records for Trabectedin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 0.05 mg/mL | Intravenous | Apotex Corp. | NDA | View NDC → |
| 0.05 mg/mL | Intravenous | Janssen Products, LP | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Trabectedin Injection NDCs →
Trabectedin Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Trabectedin Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Trabectedin Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Trabectedin Injection FDA approval history
How Trabectedin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Trabectedin Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Trabectedin recalls since July 2021.
✅No Trabectedin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1716278 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 1718588In current FDA listings
Look up RxCUI 1716278 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Trabectedin Injection supply and shortage status
Whether Trabectedin Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Trabectedin Injection brand names
Trabectedin Injection is sold under 2 brand names in the FDA directory — Yondelis, Evdi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Trabectedin Injection: manufacturers and labelers
2 companies list Trabectedin Injection products with the FDA. By number of product records, the largest are Apotex Corp., Janssen Products, LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Trabectedin Injection drug class (RxNorm)
Trabectedin Injection belongs to the Alkylating Drug class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Trabectedin Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Janssen Products, LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →