Trabectedin

Trabectedin treats soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma (cancer that begins in the soft tissues of the body). 

Trabectedin belongs to a group of drugs called antineoplastic agents. These work by killing cancer cells.

It is available for infusion to be given into a vein (IV) by a healthcare professional.

Common side effects of trabectedin include nausea, fatigue, and vomiting.

Trabectedin treats soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma (cancer that begins in the soft tissues of the body). 

Trabectedin is approved for sarcomas that cannot be removed by surgery(unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Trabectedin may be found in some form under the following brand names:

• Yondelis

Serious side effects have been reported with trabectedin. See the “Trabectedin Precautions” section.

Common side effects of trabectedin include the following:

• nausea
• fatigue
• vomiting
• diarrhea
• constipation
• decreased appetite
• shortness of breath
• headache,
• tissue swelling (peripheral edema)
• a decrease in infection-fighting white blood cells (neutropenia)
• low blood platelet counts (thrombocytopenia)
• low red blood cell count (anemia)
• elevated liver enzymes and decreases in albumin, a protein found in blood.  

This is not a complete list of trabectedin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)

Serious side effects have been reported with trabectedin including the following:

Severe infections due to decreased white blood cells. Serious infections can occur with trabectedin due to a low number of white blood cells that typically fight infections. Your healthcare provider will perform blood tests to check your white blood cell count and may lower your dose or stop treatment with trabectedin completely if you develop this side effect. Call your doctor immediately if you develop signs of an infection such as a fever, chills, sore throat, or ongoing cough and congestion.

Rhabdomyolysis (severe muscle problems). Trabectedin can cause serious muscle problems. Your doctor will perform blood tests to monitor your level of CPK, which can indicate muscle damage if high. Tell your doctor immediately if you experience any of the following signs or symptoms:

• muscle pain
• muscle weakness
• dark urine
• general weakness
• decreased urine output

Liver problems, including liver failure. Tell your healthcare provider right away if you experience any of the following signs or symptoms of liver damage:

• loss of appetite or start losing weight (anorexia)
• nausea or vomiting
• feel tired
• stomach pain or tenderness
• dark urine or light colored stools
• yellowing of your skin or the whites of your eyes
• fever or rash

Heart muscle problems, including heart failure. Your doctor will check your heart function before starting trabectedin and during treatment. Tell your doctor immediately if you start having any of the following signs or symptoms:

• chest pain
• trouble breathing
• swelling of your legs, ankles, or feet
• feel like your heart is racing or fluttering

Leakage of trabectedin out of your vein during an infusion. Serious tissue damage can occur if trabectedin leaks out of your vein when you are receiving an infusion. Immediately alert your physician if you experience redness, itching, swelling, or pain at the site where you are receiving your infusion of trabectedin.

Allergic reactions. Some of these reactions were severe. Your healthcare provider may need to stop your treatment with trabectedin, and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include: difficulty breathing, chest tightness, wheezing, swelling of the lips, or skin rash.

Do not receive trabectedin if you are allergic to trabectedin or to any of its ingredients.

Grapefruit and grapefruit juice may interact with trabectedin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before receiving trabectedin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to trabectedin or to any of its ingredients
• have liver problems
• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There have been no studies in pregnant women with trabectedin. Based on how trabectedin works, it can potentially cause serious harm to an unborn baby if given to a pregnant woman.

• Women who are able to become pregnant should use an effective form of contraception during treatment with trabectedin and for at least 2 months after the last dose of trabectedin.
• Males with female partners who are able to become pregnant should use an effective method of contraception (such as condoms) during treatment with trabectedin and for at least 5 months after the last dose.

Talk to your doctor about which method of contraception is best for you.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if trabectedin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, you should not breastfeed while on treatment with trabectedin.

This medication is available as an injectable form to be given directly into a vein (IV) by a healthcare professional. The infusion is given over 24 hours through a central line (a type of IV line that goes into a vein in your chest, arm, or groin and ends in your heart) every 21 days.

Trabectedin is typically given every 3 weeks. 

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

Before each infusion of trabectedin, your doctor will give you a steroid medicine to help reduce your risk of experiencing certain side effects.

Your doctor will determine the length of your treatment. 

If you miss an appointment to receive a dose of  trabectedin, contact your healthcare provider immediately for instructions on when to receive your next infusion.

The dose of trabectedin your doctor recommends will be based on your body surface area (calculated from your height and weight). 

The recommended dose of Yondelis (trabectedin) is 1.5 mg per m² of body surface area (calculated from your height and weight) given as an intravenous (IV) infusion over 24 hours once every 3 weeks. Your doctor will determine your length of treatment based on your disease progression and any side effects you experience.

Your doctor will perform tests to monitor for side effects to Yondelis (trabectedin) and may adjust your dose based on how you respond to this medication. If side effects become intolerable, you may need to wait longer between doses, receive a lower dose, or permanently stop the medicine if potentially serious side effects occur.

If trabectedin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor and laboratory. Your doctor will order certain lab tests to monitor your response to trabectedin.