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Yondelis (Trabectedin): Uses, Side Effects and Dosage

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Prescription (Rx)
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0.05 mg/mL
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Yondelis

What is YONDELIS?

YONDELIS is a prescription medicine used to treat adults with liposarcoma or leiomyosarcoma that:

  • cannot be treated with surgery or has spread to other areas of the body (metastatic), and
  • have received treatment with other cancer medicines, including medicines called anthracyclines.

It is not known if YONDELIS is safe and effective in children.

Who should not receive YONDELIS?

Do not receive YONDELIS if you have had a severe allergic reaction to trabectedin or any of the ingredients in YONDELIS. See the end of this leaflet for a complete list of ingredients in YONDELIS.

Before receiving YONDELIS, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems
  • have or had a history of heart problems

  • are pregnant or plan to become pregnant. YONDELIS can harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider will do a pregnancy test before you start treatment with YONDELIS.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with YONDELIS.
    • Use an effective form of birth control (contraception) during treatment and for 8 months after your last dose of YONDELIS.

    Males with female partners who are able to become pregnant:

    • YONDELIS can damage sperm and may cause birth defects.
    • Use an effective form of birth control during your treatment and for 5 months after your last dose of YONDELIS.
  • are breastfeeding or plan to breastfeed. It is not known if YONDELIS passes into your breast milk.

Do not breastfeed during treatment with and for 3 months after your last dose of YONDELIS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using YONDELIS with certain other medicines may affect the way YONDELIS works and may increase your risk of side effects. Know the medicines you take and keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine.

How will I receive YONDELIS?

  • YONDELIS is given by an intravenous (IV) infusion into a vein over 24 hours. To help avoid irritation at the site where it is infused, YONDELIS is given to you into a large vein through a type of IV line called a central venous line.
  • YONDELIS is usually given every 3 weeks.
  • Before each treatment with YONDELIS, you will receive a steroid medicine to help reduce your risk of getting certain side effects.
  • Your healthcare provider will decide how long you will continue treatment with YONDELIS.

What are the possible side effects of YONDELIS?

YONDELIS can cause serious side effects, including :

  • Severe infections due to decreased white blood cells.Decreased or low white blood cell counts can lead to severe infection throughout the body (sepsis) and death. Tell your healthcare provider right away if you develop fever or other signs of infection.
  • Muscle problems (rhabdomyolysis).YONDELIS can cause severe muscle problems and increased levels of an enzyme in your blood called creatine phosphokinase (CPK). Muscle problems can lead to death. Tell your healthcare provider right away if you develop severe muscle pain or weakness or if your urine changes to a reddish-brown color.
  • Liver problems. Increased liver enzymes in your blood and severe liver problems, including liver failure, can happen. Tell your healthcare provider right away if you develop:
  • yellowing of your skin and whites of your eyes
  • pain in your upper right stomach-area (abdomen)
  • nausea
  • vomiting
  • problems with concentration
  • disorientation
  • confusion
  • Heart muscle problems.Heart muscle problems, including heart failure, can be severe and lead to death. Your healthcare provider will do a test to check your heart function before you start and during treatment with YONDELIS. Tell your healthcare provider right away if you develop new chest pain, shortness of breath, tiredness, swelling of your legs, ankles, or feet, or heart palpitations.
  • Capillary leak syndrome (CLS).YONDELIS can cause fluid to leak from the blood vessels into the body’s tissues. CLS can cause symptoms that can lead to death. Tell your healthcare provider right away if you develop swelling, dizziness or lightheadedness with or without a sudden drop in blood pressure.
  • Skin damage from leakage at or near the infusion site.YONDELIS can cause damage and death of tissue cells if it leaks into the tissues around your infusion site. You may need to have surgery to remove any dead tissue. Tell your healthcare provider right away if you see any YONDELIS leaking out of your vein or around the catheter during your infusion, or if you notice any redness, swelling, itching or discomfort at the infusion site at any time.
  • Allergic reactions.Some people have had allergic reactions to YONDELIS, including severe reactions. Get emergency help right away if you develop any of the following signs or symptoms of an allergic reaction: difficulty breathing, chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, or skin rash.

The most common side effects of YONDELIS include:

  • nausea
  • tiredness
  • vomiting
  • constipation
  • decreased appetite
  • diarrhea
  • swelling of your hands, ankles, or feet
  • shortness of breath
  • headache

The most common severe abnormal blood tests include:

  • decreased white blood cell, platelet, and red blood cell (anemia) counts. Tell your healthcare provider right away if you develop fever or signs of infection, unusual bruising, bleeding, tiredness, or paleness.
  • increased liver enzymes and CPK.

Your healthcare provider will do certain blood tests before you start YONDELIS and during treatment to check you for side effects, and to see how well you respond to the treatment.

Your healthcare provider may decrease or delay your dose if you develop serious side effects or may permanently stop treatment with YONDELIS if your side effects are severe.

YONDELIS may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of YONDELIS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of YONDELIS

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about YONDELIS that is written for health professionals.

What are the ingredients in YONDELIS?

Active ingredient: trabectedin

Inactive ingredients:potassium dihydrogen phosphate, sucrose, phosphoric acid and potassium hydroxide.

Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA

For more information, call 1-800-526-7736 or go to www.YONDELIS.com.

For patent information: www.janssenpatents.com

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 207953 · View the label on DailyMed

Revision date stated in the text: December 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Yondelis

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Alkylating Drug
Active ingredient Trabectedin 0.05 mg/mL
Dosage form Injection, powder, lyophilized, for solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) JANSSEN PRODS
FDA approval NDA 207953New Drug Application (NDA) Approved October 23, 2015
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.05 mg/mL – 20 ml in 1 vial, single-use NDC 59676-610-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.