Yondelis
Yondelis (trabectedin) is FDA approved to treat adults with advanced liposarcoma or leiomyosarcoma, which are rare types of soft tissue sarcoma. It’s a chemotherapy medication that works as an alkylating agent to treat the cancer. Yondelis (trabectedin) is given through a vein as an infusion once every 3 weeks. The medication is given over 24 hours. Because of this, it’s given in a hospital or there might be an option to wear a small portable infusion pump. Side effects can include a low blood cell count, nausea, and muscle problems.
What is Yondelis (trabectedin)?
What is Yondelis (trabectedin) used for?
- Liposarcoma that has spread or can’t be removed by surgery, previously treated with anthracycline chemotherapy
- Leiomyosarcoma that has spread can’t be removed by surgery, previously treated with anthracycline chemotherapy
How Yondelis (trabectedin) works
Yondelis (trabectedin) is a type of traditional chemotherapy called an alkylating agent. It works by attaching to the DNA of fast-growing cells in the body, including cancer cells. It damages the DNA, which usually causes the cancer cell to die. This slows or stops cancer cells from growing.
Drug facts
| Common Brands | Yondelis |
|---|---|
| Drug Class | Alkylating agent |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Yondelis (trabectedin)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Anemia (low red blood cell count; 96%)
- High liver enzyme levels (up to 90%)
- Nausea (75%)
- Tiredness (69%)
- Lower white blood cell count (66%)
- Low protein levels (63%)
- Lower platelet count (59%)
- Higher creatinine levels (46%)
- Vomiting (46%)
- Constipation (37%)
- Lower appetite (37%)
- Diarrhea (35%)
- Higher creatine phosphokinase levels (33%)
- Swelling in the arms, legs, or feet (28%)
- Headache (25%)
- Shortness of breath (25%)
Less Common Side Effects
- Muscle aches
- Joint aches
- Numbness or tingling feeling
- Trouble sleeping
Yondelis (trabectedin) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infection: temperature of 100.4ºF or higher, with or without other symptoms such as chills, cough, muscle aches, very fast heartbeat, confusion
- Serious blood problems: severe tiredness, frequent nosebleeds, unexplained bruising, bleeding that’s hard to stop
- Serious liver problems: yellow skin or eyes, belly pain, swollen belly
- Serious muscle problems: unexplained sudden and severe muscle pain, muscle weakness, dark brown urine
- Capillary leak syndrome: swelling in arms and legs, trouble breathing, feeling dizzy or lightheaded, passing out
The following Yondelis (trabectedin) side effects have also been reported
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
Pros and cons of Yondelis (trabectedin)
Pros
- A recommended next-choice option for advanced liposarcoma and leiomyosarcoma
- Given once every 3 weeks
- Choice of getting the infusion in a hospital or using a small portable infusion pump
Cons
- Can cause nausea
- Has a risk of a serious muscle problem called rhabdomyolysis
- Not recommended for people with severe liver problems
Pharmacist tips for Yondelis (trabectedin)
- Write down your Yondelis (trabectedin) infusion appointments on your calendar. You’ll get treatment once every 3 weeks. Writing down your appointment dates can help you stay on track with treatment.
- Yondelis (trabectedin) is given as an infusion through a vein over 24 hours. Talk with your oncologist about whether you’ll get it at a hospital or use a small portable pump at home. Depending on which way, your care team will give you clear instructions on what to expect for the infusion.
- You’ll probably get Yondelis (trabectedin) infused through a special intravenous (IV) line. This helps prevent tissue damage around the infusion site in case the medication leaks out. But tell your oncology care team if you notice any pain, redness, or swelling around the infusion area.
- Your care team will give you dexamethasone through a vein 30 minutes before each Yondelis (trabectedin) infusion. This might help prevent or manage certain side effects, like nausea and liver damage.
- Yondelis (trabectedin) often causes mild nausea and vomiting. Your oncologist will prescribe anti-nausea medications, like ondansetron (Zofran) or prochlorperazine, to take at home. If nausea or vomiting bothers you too much, talk to your care team.
- Call your care team right away if you have sudden, severe muscle pain, weakness, or red-brown urine. Yondelis (trabectedin) has a risk of causing serious muscle problems like rhabdomyolysis. Your care team can check out what’s going on.
- Wash your hands often and try to stay away from large crowds and people who are sick while taking Yondelis (trabectedin). This medication often causes low white blood cell counts. This can make it easier for you to get sick.
- Check your temperature regularly, like once a day, while taking Yondelis (trabectedin). Call your care team right away if it’s 100.4ºF or higher since it means you have a fever. Sometimes, that's the only sign that you’re sick.
- Tell your oncologist about all the medications you take, including any new ones. Yondelis (trabectedin) can interact with some medications. For example, ketoconazole tablets can raise your risk of side effects from Yondelis (trabectedin). And some seizure medications and the herbal supplement St. John’s wort can make Yondelis (trabectedin) work less well. Your oncologist can check for drug interactions and make changes if needed to keep you safe.
- If you can become pregnant: Use reliable birth control while taking Yondelis (trabectedin). Keep using birth control for at least 8 months after you stop this medication. Yondelis (trabectedin) might harm an unborn baby. Tell your oncologist right away if you become pregnant.
- If your partner can become pregnant: Use birth control like condoms during sex while you’re taking Yondelis (trabectedin) and for at least 5 months after your last dose. This medication might cause harm to an unborn baby. Let your oncologist know if your partner gets pregnant.
Risks and warnings for Yondelis (trabectedin)
Yondelis (trabectedin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious infection
Some people had low white blood cell counts while taking Yondelis (trabectedin). Sometimes, white blood cell counts can drop very low, which can be dangerous. White blood cells help your body fight infection. When they’re very low, it’s possible for serious fevers and infections like sepsis to happen. This can sometimes be life-threatening.
Your oncologist will check your blood cell counts before each Yondelis (trabectedin) infusion and from time to time during the treatment cycle. If your levels are too low, your oncologist might pause your treatment or lower your dose of Yondelis (trabectedin).
Call your oncology care team right away if you have a fever of 100.4ºF or higher during treatment. Also tell them about any other signs of infection.
Serious muscle problems, including rhabdomyolysis
Sometimes, people taking Yondelis (trabectedin) can have muscle problems. In some cases, it can be very serious, such as with rhabdomyolysis. This happens when muscles get damaged and start to break down. This muscle breakdown can sometimes lead to kidney problems.
Your oncologist will check the levels of creatine phosphokinase (CPK) in your blood before each Yondelis (trabectedin) infusion. High CPK levels can be a sign of muscle damage. If your levels are too high, your oncologist might pause your treatment, lower your Yondelis (trabectedin) dose, or stop treatment altogether.
Be aware of symptoms of rhabdomyolysis. These include muscle pain, weakness, and dark brown urine. You might also have stomach upset, have a very fast heart rate, feel confused, or urinate less. If you notice any of these symptoms, call your care team right away so they can check what’s going on.
Serious liver problems
- Risk factors: History of liver problems
Yondelis (trabectedin) can irritate the liver. In rare cases, this can be serious and lead to liver failure. Your oncologist will check your liver with blood tests before each Yondelis (trabectedin) infusion. If you already have liver problems, they might check more often.
If your liver labs are too high, your oncologist might pause treatment, lower your dose of Yondelis (trabectedin), or stop the medication. Most times, liver enzyme levels go back to a normal range.
Also watch for signs of liver problems while taking Yondelis (trabectedin). This can include yellow skin or eyes, belly pain, nausea, or vomiting. If this happens, tell your care team so they can check your liver with a blood test.
Serious heart problems
- Risk factors: Age 65 years or older | History of heart problems | Lower than normal ejection fraction | History of a high cumulative anthracycline dose
Although it’s rare, some people taking Yondelis (trabectedin) had serious heart problems. These can include heart failure and lower ejection fraction (when the heart can’t pump as well). In studies, there were few cases of life-threatening heart problems. Tell your oncologist if you already have heart problems so they can watch you more closely.
Before you start Yondelis (trabectedin), your oncologist will check how healthy your heart is. This is done with a heart scan called an echocardiogram (echo) or a MUGA scan. You’ll also need to get this scan done every 2 to 3 months during treatment.
Tell your oncology care team if you notice any symptoms of heart problems while taking Yondelis (trabectedin). Watch for new chest pain, shortness of breath, tiredness, swelling in your legs or feet, or a racing heart. If serious heart problems happen, you might have to stop Yondelis (trabectedin).
Capillary leak syndrome
It’s not common, but some people taking Yondelis (trabectedin) developed a condition called capillary leak syndrome. This can sometimes be life-threatening. The reaction happens when fluid leaks out of small blood vessels into nearby tissue. It can cause swelling in the arms or legs, dizziness, and lightheadedness. It might also cause a sudden drop in blood pressure, which can be dangerous. Call your oncology care team right away if you notice these symptoms while taking Yondelis (trabectedin).
Tissue damage around the infusion site
Yondelis (trabectedin) can accidentally leak out of the vein into the tissues near the infusion site. This might damage the skin and tissue in that area. The damage might not show up until more than a week after the leak actually happens. To help prevent this, your oncology care team will give Yondelis (trabectedin) through a central line, such as a port. If you’re not sure what kind of central line you have, ask your oncologist. Let your care team know if you feel any pain or redness near your infusion site.
Harm to an unborn baby
- Risk factors: Pregnancy
Based on how Yondelis (trabectedin) works, this medication might harm an unborn baby if given during pregnancy. If you can become pregnant, use effective birth control while taking Yondelis (trabectedin) and for at least 8 months after your last dose. If you’re sexually active with someone who can get pregnant, also use birth control such as condoms during treatment and for at least 5 months after you stop this medication. If you or your partner gets pregnant, tell your oncologist right away.
Yondelis (trabectedin) dosage
Typical dosage for Yondelis (trabectedin)
Your oncologist will find the dose for you based on your body size or body surface area (BSA). They’ll take your height and weight into account and calculate BSA in m² units.
The typical dose is 1.5 mg/m² infused through the vein over 24 hours. It’s given once every 3 weeks.
Some people with liver problems will need to take a lower dose (0.9 mg/m² infused once every 3 weeks).
Your dose might also be lowered if you have serious side effects.
