Yondelis is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Yondelis is used to treat liposarcoma, a rare type of cancer that grows in fatty tissues of the body.

Yondelis is also used to treat leiomyosarcoma, a rare fast-growing type of cancer that grows in many tissues of the body, including fat, muscle, bone, joints, and blood vessels.

Yondelis is used to treat cancer that has spread to other parts of the body or cannot be treated with surgery.

Yondelis affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, mouth sores, skin sores, sore throat, cough, or trouble breathing.

Yondelis is given as an infusion into a vein, through a central line IV. A healthcare provider will give you this injection.

Before you receive a dose of trabectedin, you may need a blood test to check your liver function.

Yondelis must be given slowly and the infusion can take up to 24 hours to complete.

Yondelis is usually given once every 3 weeks. Your doctor will determine how long to treat you with trabectedin.

You may be given steroid medication to prevent certain side effects of trabectedin.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Yondelis is injected.

Trabectedin affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Usual Adult Dose for Soft Tissue Sarcoma:

-Normal Bilirubin and AST or ALT 2.5 Times the Upper Limit of Normal (ULN) or Less:
1.5 mg/m2 via IV infusion every 21 days (3 weeks)

-Serum Bilirubin Levels Above Institutional ULN:
No recommended dose.

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:
-Administer this drug over 24 hours through a central venous line using an infusion set with a 0.2 micron polyethersulfone (PES) in-line filter.
-Complete infusion within 30 hours of drug reconstitution.
-Administer dexamethasone 20 mg IV 30 minutes prior to each dose.

Use: Treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

You should not be treated with Yondelis if you are allergic to trabectedin.

Tell your doctor if you have ever had:

• liver disease;

• heart disease; or

• kidney disease.

Yondelis can harm an unborn baby or cause birth defects if the mother or the father is taking this medicine.

• If you are a woman, do not use this medicine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 5 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Yondelis.

You should not breast-feed while using trabectedin.

Call your doctor for instructions if you miss an appointment for your Yondelis injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Grapefruit may interact with trabectedin and lead to unwanted side effects. Avoid the use of grapefruit products.

Trabectedin can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Yondelis: hives; chest tightness, wheezing, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Capillary leak syndrome is a rare but serious side effect of trabectedin. Tell your doctor right away if you have signs of this condition: stuffy or runny nose followed by weakness or tired feeling, and sudden swelling in your arms, legs and other parts of the body.

Call your doctor at once if you have:

• pain, burning, irritation, or skin changes where the injection was given;

• heart problems - chest pain, fast or pounding heartbeats, shortness of breath (even with mild exertion), swelling, rapid weight gain;

• breakdown of muscle tissue - unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine);

• liver problems - nausea, upper stomach pain, confusion, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Yondelis side effects may include:

• nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• swelling, tiredness;

• low blood cell counts;

• abnormal liver or kidney function tests;

• headache; or

• feeling short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with trabectedin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.