View by Tumor Type
Sarcoma Ovarian Cancer
Home › All Therapies › Yondelis

Yondelis

trabectedin
Alkylating Agent FDA Approved 2015 Janssen
Route
IV
Half-Life
180 hrs
FDA Approved
2015
Manufacturer
Janssen
Navigation -->
1. Indications and Usage

Liposarcoma/leiomyosarcoma after anthracycline.

2. Dosage and Administration

1.5 mg/m2 IV over 24h Q3W.

3. Dosage Forms and Strengths

1 mg powder/vial

4. Contraindications

Severe hypersensitivity.

5. Warnings and Precautions
  • Neutropenic Sepsis: Fatal.
  • Rhabdomyolysis: Monitor CPK.
  • Hepatotoxicity: Monitor LFTs.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Nausea (75%), Fatigue (69%), Neutropenia (58%), Vomiting (46%), Anemia (42%), ALT Elevation (41%)

Nausea
75%
Fatigue
69%
Neutropenia
58%
Vomiting
46%
Anemia
42%
ALT Elevation
41%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Avoid strong CYP3A4 inhibitors.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Minor groove DNA binder causing strand breaks.

Pharmacokinetics

Vd: >5000 L. t1/2: ~175h.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Yondelis Trials on ClinicalTrials.gov ↗ 📚 PubMed: Yondelis Clinical Trials ↗
FDA-Approved Tumor Types

Yondelis has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Sarcoma
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Yondelis. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Yondelis (trabectedin) approved for?

Yondelis (trabectedin) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Yondelis (trabectedin) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Yondelis (trabectedin) work?

Minor groove DNA binder causing strand breaks.

What are the most common side effects?

Nausea (75%), Fatigue (69%), Neutropenia (58%), Vomiting (46%), Anemia (42%), ALT Elevation (41%) Nausea 75% Fatigue 69% Neutropenia 58% Vomiting 46% Anemia 42% ALT Elevation 41%

← All Therapies Full Prescribing Information ↗