Yondelis - Trabectedin Injection

What is this medication?

TRABECTEDIN (tra BEK te din) treats sarcoma, a cancer that occurs in bone and connective tissues, such as fat, muscle, and blood vessels. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Yondelis

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Kidney disease
• Liver disease
• An unusual or allergic reaction to trabectedin, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

• Antiviral medications for HIV or AIDS
• Boceprevir
• Certain antibiotics, such as clarithromycin, telithromycin
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Conivaptan
• Grapefruit juice
• Nefazodone
• Rifampin
• St. John's wort
• Telaprevir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. This medication may make you feel generally unwell. This is not uncommon in medications used to treat cancer. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

This medication can cause serious allergic reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Follow the directions from your care team.

You may need blood work done while you are taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

Your care team may tell you to stop taking this medication if you develop muscle problems. If your muscle problems do not go away after stopping this medication, contact your care team.

Talk to your care team if you or your partner may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 8 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 8 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 5 months after the last dose.

Do not breastfeed while taking this medication and for 3 months after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Capillary leak syndrome—stomach or muscle pain, unusual weakness or fatigue, feeling faint or lightheaded, decrease in the amount of urine, swelling of the ankles, hands, or feet, trouble breathing
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
• Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site
• Stomach pain, unusual weakness or fatigue, nausea, vomiting, diarrhea, or fever that lasts longer than expected
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Diarrhea
• Fatigue
• Headache
• Loss of appetite
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.