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Class: Chemotherapy

Generic Name: Trabectedin

Trade Name: Yondelis®

For which conditions is Yondelis approved for? Yondelis is approved for the treatment of adults with liposarcoma or leiomyosarcoma that cannot be treated with surgery or has spread to other areas of the body and for patients who have received treatment with certain other medicines.

What is the mechanism of action? Yondelis helps fight cancer by preventing the tumor cells from multiplying and also kills cancer cells. It works by blocking certain types proteins (transcription factors) that are involved the copying and sending of tumor cell DNA.

How is Yondelis typically given (administered)? You’ll receive Yondelis once every three weeks through an infusion into a large vein in your body. Each infusion will take 24 hours. Your doctor will also give you a steroid medicine to help reduce your risk of getting certain side effects before each infusion.

How are patients typically monitored? While you’re receiving treatment with Yondelis, your doctor will monitor your neutrophil (a type of white blood cell) count; you’ll need to stop treatment if your neutrophil levels become too low (neutropenia). Your doctor will a also check for a condition called rhabdomyolysis in which muscles tissue breaks down, releasing muscle fiber into the bloodstream; and for increases in creatine phosphokinases levels, a condition that indicates damage to tissue in the brain, muscle tissue, or heart. Your liver and heart function will also be monitored during treatment. You may have to stop treatment with Yondelis if you experience any complications in these areas.

What are the common (occur in 30% or more of patients) side effects of treatment with Yondelis?

  • Nausea
  • Vomiting
  • Constipation
  • Diarrhea
  • Fatigue
  • Decreased appetite

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Yondelis?

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  • Peripheral edema
  • Headache
  • Insomnia
  • Joint pain
  • Muscle pain
  • Difficult or labored breathing

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Avoid grapefruit and grapefruit juice during treatment with Yondelis.
  • Tell your doctor if you have liver or kidney problems or any other health conditions.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Are there any special precautions patients should be aware of before starting treatment?

  • Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant during treatment because Yondelis can harm your unborn baby.
  • If you are woman who is able to become pregnant, use an effective form of birth control during treatment and for at least two months after your last dose.
  • Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment because it is not known if Yondelis passes into your breast milk.
  • Men should use an effective form of birth control when having sex with female partners who are able to become pregnant. Use birth control during treatment and for at least five months after your last dose.

When should patients notify their physician?

  • Tell your doctor if you think you are having an allergic reaction to Yondelis. Signs of an allergic reaction can include: difficulty breathing, chest tightness, wheezing, swelling of the lips, or skin rash.
  • Tell your doctor right away if you have signs of a heart problem or heart failure. These signs include new chest pain, shortness of breath, tiredness, swelling of your legs, ankles, or feet, or heart palpitations.
  • There is a risk that Yondelis can leak into the tissues around your infusion site, which can cause damage and death of these tissue cells. 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, swelling, itching or discomfort at the infusion site.
  • Tell your doctor right away if you have severe muscle pain or weakness.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.