Home

 / 

Safety Considerations

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
  • Severe muscle problems (rhabdomyolysis)
  • Liver problems
  • Heart muscle problems
  • Leakage during the infusion
  • Allergic reactions
  • Capillary leak syndrome

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.

Learn more about treatment with YONDELIS®.

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.

Learn more about treatment with YONDELIS®.

Liver problems

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

Learn more about treatment with YONDELIS®.

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.

Learn more about treatment with YONDELIS®.

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.

Learn more about treatment with YONDELIS®.

Allergic reactions

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).

Learn more about treatment with YONDELIS®.

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®.

Severe infections

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.

Learn more about treatment with YONDELIS®.

Severe muscle problems (rhabdomyolysis)

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.

Learn more about treatment with YONDELIS®.

Liver problems

Liver problems

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

Learn more about treatment with YONDELIS®.

Heart muscle problems

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.

Learn more about treatment with YONDELIS®.

Leakage during the infusion

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.

Learn more about treatment with YONDELIS®.

Allergic reactions

Allergic reactions

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).

Learn more about treatment with YONDELIS®.

Capillary leak syndrome

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.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION AND INDICATION

EXPAND Expand isi