YONDELIS for Treatment of Liposarcoma and Leiomyosarcoma

YONDELIS is a prescription medicine used to treat people with liposarcoma or leiomyosarcoma that:
• has spread to other areas of the body, or cannot be treated with surgery, and
• who has received treatment with other certain medicines.

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

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

Store YONDELIS vials in a refrigerator at 2°C to 8°C (36°F to 46°F). YONDELIS is a cytotoxic drug (handle with care).

You will not receive YONDELIS if you have had a severe allergic reaction to trabectedin, the active
ingredient present in YONDELIS.

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

• have kidney or liver problems

• are pregnant or planning to become pregnant. YONDELIS can harm your unborn baby so, you should not become pregnant during treatment with YONDELIS. Females who are able to become pregnant should use an effective form of contraception during treatment with YONDELIS and for 2 months after your last dose of YONDELIS. Males should use an effective form of contraception when having sex with female partners who are able to become pregnant, during your treatment with YONDELIS, and for 5 months after your last dose of YONDELIS.

• are breastfeeding or planning to breastfeed. It is not known if YONDELIS passes into your breast milk. You should not breastfeed during treatment with YONDELIS.

• Tell your doctor about all the medicines you’re taking including over-the-counter medicines, prescriptions, vitamins, and herbal supplements.

• You will receive YONDELIS by an intravenous (IV) infusion into a vein over 24 hours. To 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.

• Your doctor may decrease your dose or delay doses if you have certain side effects. If you have any side effects that are severe, your doctor may stop your treatment with YONDELIS.

• Before each treatment with YONDELIS, you will receive a steroid medicine to help reduce your risk of getting certain side effects.

• Your doctor will decide how long you will continue treatment with YONDELIS.

• Your doctor may conduct certain tests while you are receiving YONDELIS to see how well you respond to the treatment and also check for side effects.

• nausea
• tiredness
• vomiting
• constipation
• decreased appetite
• diarrhea
• swelling of your hands, ankles, or feet
• shortness of breath
• headache
• decreased red cell count. Tell your doctor if you feel more tired than usual or look pale.
• decreased platelet cell counts. Tell your doctor if you bruise easily or have bleeding.
• changes in liver and kidney function blood tests

YONDELIS may cause serious side effects, including:

• Severe infections (Neutropenic sepsis) due to decreased white blood cells: Decreased low white blood cell count is common with YONDELIS, but it can also lead to severe infections and death. Your doctor may need to decrease your dose of YONDELIS, delay or stop your treatment if your white blood cell count is too low or if you get a serious infection. Call your doctor right away if you develop fever or other signs of infection.

• Severe muscle problems (rhabdomyolysis): YONDELIS can cause severe muscle problems and lead to death. Tell your doctor right away if you have severe muscle pain or weakness.

• Liver problems: Tell your doctor right away if you get yellowing of your skin and whites of your eyes, pain in your upper right stomach area (abdomen), nausea, vomiting, generally do not feel well, problems with concentration, confusion, sleepiness.

• Heart muscle problems, including heart failure: Your doctor will do a test to check your heart function before you start YONDELIS, and during treatment. If you develop heart failure or heart muscle problems during treatment with YONDELIS, your doctor may stop your treatment. Tell your doctor right away if you develop new chest pain, shortness of breath, swelling of your legs tiredness, ankles, or feet, or heart palpitations.

• YONDELIS might leak out of your vein during the infusion: If YONDELIS leaks into the tissues around your infusion site, it can damage the tissue cells around the infusion site. You may need to have surgery to remove any dead tissue. Tell your doctor 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, itching, swelling, or discomfort at the infusion site at any time.

• Allergic reactions to YONDELIS: Some of these reactions can be severe. Your doctor 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 wheezing, swelling of the lips, difficulty breathing, chest tightness, or skin rash.

• 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 doctor right away if you develop swelling, or dizziness with or without a sudden drop in blood pressure.