Trabectedin, Injection

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KEY POINTS

• This medicine is given by IV infusion to treat liposarcoma or leiomyosarcoma.
• You may get infections more easily when you are taking this medicine. This medicine may cause certain severe blood and bone marrow problems that affect your body's ability to stop bleeding or fight infection.
• This medicine may cause serious or life-threatening heart problems during treatment or months to years after stopping treatment. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Keep all appointments for tests to see how this medicine affects you.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); chemotherapy

Generic and brand names: trabectedin, injection; Yondelis

What is this medicine used for?

This medicine is given by IV infusion to treat liposarcoma or leiomyosarcoma:

• That has spread or cannot be removed by surgery
• After you have taken other medicine and it did not work or is no longer working

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Heart problems
• Kidney or liver disease

Tell your healthcare provider if you have any signs of infection such as cough, shortness of breath, sore throat, fever, chills, or mouth sores before starting this medicine.

This medicine may make you sterile (unable to have children) whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant while you are receiving this medicine because it may harm the baby. Use effective birth control during treatment with this medicine and for at least 2 months after you stop treatment. Contact your healthcare provider at the first sign of pregnancy. Do not breast-feed while receiving this medicine.

Males: This medicine may damage your sperm. Use effective birth control during treatment with this medicine and for at least 5 months after you stop treatment.

How do I use it?

This medicine is given by IV infusion into a central venous line by healthcare providers experienced in providing chemotherapy. You will receive this medicine over a 24 hour period where you can be carefully monitored.

While receiving this medicine, report any symptoms of chest tightness, back pain, or flushing. The infusion can be given at a slower rate to prevent these problems.

If this medicine leaks from your veins into nearby tissue, it may stain your skin brown or cause redness, pain, or blisters. Alert your healthcare provider if you have pain during treatment.

You may need several treatments with this medicine. Blood and bone marrow tests are used to determine how many courses of treatment you will need.

What should I watch out for?

You will need to have blood and bone marrow tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine may cause serious or life-threatening heart problems during treatment or months to years after stopping treatment. These heart problems may be permanent. Your risk may be higher if you:

• Already have heart problems
• Have had radiation therapy to your chest
• Have received certain other anticancer medicines
• Take other medicines that can also cause heart problems

Your healthcare provider will monitor your heart before, during, and after treatment. Contact your healthcare provider right away if you have any symptoms of heart problems.

While you are taking this medicine, report any unusual or ongoing muscle pain, tenderness, or weakness to your healthcare provider right away, especially if you also have a fever or unusual tiredness. Also, contact your healthcare provider right away if these symptoms do not go away even after you stop taking this medicine.

This medicine can cause liver problems. Contact your healthcare provider right away if you have severe tiredness, nausea, vomiting, dark urine, or yellowing of your eyes and skin. These are signs of possible liver damage.

You may get serious infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Redness, swelling or pain at the infusion site; irregular, fast, or slow heart rate; chest pain; shortness of breath that continues; unusual or ongoing muscle pain, tenderness, or weakness, especially if you also have a fever or unusual tiredness; sudden weight gain or unexplained swelling; cough; fever; sore throat; burning or pain with urination; decreased urination; dark urine; yellowing of the skin and eyes; unusual bruising or bleeding; unusual tiredness or weakness; black, bloody, or tarry bowel movements; severe stomach pain; severe or continued nausea, vomiting, or diarrhea.

Other: Loss of appetite, trouble sleeping, nausea, diarrhea, vomiting, constipation, headache, mild tiredness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Aprepitant (Emend)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), afatinib (Gilotrif), bosutinib (Bosulif), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), topotecan (Hycamtin), and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz/emtricitabine/tenofovir (Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Lumacaftor/ivacaftor (Orkambi)
• Mifepristone (Korlym, Mifeprex)
• Natural remedies such as red yeast rice and St. John’s wort
• Nefazodone
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Do not have any vaccines without getting your healthcare provider's approval first.

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.