Trabectedin

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

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

Trabectedin is also used to treat leiomyosarcoma, a rare and fast-growing type of cancer that can occur in various tissues of the body, such as fat, muscle, bone, joints, and blood vessels.

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

Trabectedin may also be used for reasons not mentioned in this medication guide.

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.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when trabectedin 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).

Trabectedin can impact your immune system. You may become more susceptible to infections, including serious or life-threatening ones. Contact your doctor if you experience a fever, mouth sores, skin sores, a sore throat, a cough, or difficulty breathing.

You should not receive trabectedin if you are allergic to it.

Inform your doctor if you have ever had:

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

Trabectedin can harm an unborn baby or cause birth defects if either the mother or the father is taking trabectedin.

• If you are a woman, do not use trabectedin if you are pregnant. You may need to take a pregnancy test that shows you are not pregnant before starting this treatment. Use effective birth control to prevent pregnancy while taking 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 can become pregnant. Continue using birth control for at least 5 months after your last dose.
• Inform your doctor immediately if a pregnancy occurs while either the mother or the father is using trabectedin.

You should not breast-feed while taking trabectedin.

Get emergency medical help if you have signs of an allergic reaction: 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 feeling tired, and sudden swelling in your arms, legs, and other parts of the body.

Trabectedin may cause serious side effects. 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 side effects of trabectedin 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.

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.

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

Since trabectedin is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

Grapefruit may interact with trabectedin and cause unwanted side effects. Avoid using grapefruit products.

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

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.