Safety Considerations

Possible serious side effects with YONDELIS®

In some cases, YONDELIS® may cause serious side effects. These are some of the possible side effects.

Severe infections
These are due to decreased white blood cells. Decreased white blood cell count is common with YONDELIS®, but it can also lead to severe infections and death. If your white blood cell count is too low or you get a serious infection, your healthcare provider may need to decrease your dose of YONDELIS®, delay treatment, or stop your treatment altogether. If you develop fever or other signs of infection, call your healthcare provider right away.

Severe muscle problems (rhabdomyolysis)
YONDELIS® can cause muscle problems that can be severe and lead to death. If you have severe muscle pain or weakness, tell your healthcare provider right away.

Liver problems
This may include liver failure. Tell your healthcare provider right away if you experience yellowing of your skin and whites of your eyes, you generally do not feel well, you have pain in your upper right stomach-area (abdomen), you notice a problem with concentrating, you become nauseous, you feel confused, you start vomiting, or you become overly sleepy.

Heart muscle problems
This can include heart failure. Your healthcare provider will do a test to check your heart function before you start YONDELIS®, and during treatment. If you develop heart muscle problems or heart failure during treatment with YONDELIS®, your doctor may stop your treatment. 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.

Leakage of YONDELIS® out of your vein during the infusion
If YONDELIS® leaks into the tissues around your infusion site, it can cause damage and death of tissue cells around the 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 reaction
Some people have had allergic reactions to YONDELIS®. Some of these reactions were severe. Your healthcare provider may need to stop your treatment with YONDELIS®, and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include: difficulty breathing, chest tightness, wheezing, swelling of the lips, or skin rash. You should not take YONDELIS® if you know that you are allergic to trabectedin (the active ingredient in YONDELIS®), or to any of the inactive ingredients (potassium dihydrogen phosphate, sucrose, phosphoric acid, and potassium hydroxide).

Capillary leak syndrome
YONDELIS® can cause fluid to leak from the blood vessels into the body's tissues. This condition is called "Capillary Leak Syndrome" (CLS). CLS can cause you to have symptoms that may 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.

Learn more about treatment with YONDELIS®.

 

What are the most common side effects of YONDELIS®?

  • Nausea
  • Tiredness
  • Vomiting
  • Constipation
  • Decreased appetite
  • Diarrhea
  • Swelling of your hands, ankles, or feet
  • Shortness of breath
  • Headache
  • Decreased red cells that carry oxygen in the blood (tell your healthcare provider if you feel more tired than usual or look pale)
  • Decreased platelets, cells that help blood to clot (tell your healthcare provider if you bruise easily or have bleeding)
  • Changes in results from liver and kidney function tests

 

What to do if you experience side effects

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 also report side effects to US Food and Drug Administration (FDA) at 1-800-FDA-1088.