trabectedin

What is the most important information I should know about trabectedin?

What is trabectedin?

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

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

Trabectedin 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.

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

Trabectedin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving trabectedin?

Tell your doctor if you have ever had:

• liver disease;
• heart disease; or
• kidney disease.

• If you are a woman, do not use trabectedin 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 trabectedin.

How is trabectedin given?

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

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

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

Trabectedin 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.

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).

What happens if I miss a dose?

What happens if I overdose?

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

What should I avoid while receiving trabectedin?

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

What are the possible side effects of trabectedin?

• 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 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.

What other drugs will affect trabectedin?

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 affect 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.

Where can I get more information?

Your doctor or pharmacist can provide more information about trabectedin.