trabectedin 1 mg intravenous solution

Generic name:
Trabectedin - injection

Pronunciation
(tra-BEK-te-din)

Brand name(s)
Yondelis

Trabectedin may cause serious infection and injection site/liver/muscle/lung problems. It should not be used by people with liver problems (such as active hepatitis, increased bilirubin levels). Your doctor will order blood tests to monitor for problems before starting and during treatment with this medication. See also Side Effects section.

Trabectedin is used to treat certain types of cancer. It is a chemotherapy drug that works by slowing the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start using trabectedin and before each treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a large vein (central line) by a health care professional. It is usually given every 3 weeks.

Your doctor will order a corticosteroid (such as dexamethasone) to lower the risk of liver problems or prevent side effects such as nausea/vomiting. These medications are usually given at least 30 minutes before your dose of trabectedin.

The dosage is based on your height, weight, medical condition, lab test results, and response to treatment.

Headache, weakness, tiredness, constipation, diarrhea, body aches, skin darkening, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Nausea and vomiting can also occur and may be severe. Tell your doctor right away if these effects occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help to lessen the nausea and vomiting.

Many people using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Trabectedin may cause serious injury at the injection site. Tell your health care professional right away if you experience pain, irritation, redness, or swelling at the injection site. Prompt treatment will help reduce discomfort and possible skin damage.

Trabectedin decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. Your doctor will monitor you closely and check your blood often during treatment. You may also receive another medication to reduce the risk of this side effect. If your blood cell count is too low, you should not receive trabectedin. Tell your doctor right away if you develop any of the following symptoms:

• unusual tiredness
• pale skin
• signs of infection (such as sore throat that doesn't go away, fever, chills)
• easy bruising/bleeding

This medication may cause liver problems. Alcohol can increase the risk of liver problems. Do not drink alcoholic beverages. Your doctor will order blood tests to check for liver problems. Tell your doctor right away if you notice any of the following serious side effects:

• nausea/vomiting that doesn't stop
• yellowing eyes/skin
• dark urine
• severe stomach/abdominal pain

This drug may rarely cause serious muscle problems (rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms:

• muscle pain/tenderness/weakness
• signs of kidney problems (such as change in the amount of urine)

This medication may rarely cause a blood clot in the lungs (pulmonary embolism) or serious heart problems. Get medical help right away if you have:

• chest pain
• trouble breathing
• coughing up blood
• swelling ankles/feet
• sudden unexplained weight gain
• severe tiredness
• fast heartbeat

This medication may rarely cause a serious condition (capillary leak syndrome), that can sometimes be fatal. Get medical help right away if you develop symptoms, including:

• sudden swelling
• shortness of breath
• signs of kidney problems (such as passing less urine)
• severe dizziness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving trabectedin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain other inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• low blood cell counts
• liver disease (such as active hepatitis)
• kidney disease
• recent/current infections
• heart disease (such as heart failure)

This drug may make you feel tired or weak. Alcohol or marijuana (cannabis) can make you more tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Alcohol can increase the risk of liver problems. Talk to your doctor if you are using marijuana (cannabis). .

Trabectedin can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using trabectedin before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for heart problems while using this drug.

This medication may damage sperm in men. For both men and women using this medication, trabectedin may decrease the ability to have children in the future. Consult your doctor for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor right away. To avoid pregnancy, both men and women receiving this drug should use reliable form(s) of birth control (such as birth control pills, condoms) during treatment, and for 3 months after treatment for women, and for 5 months after treatment for men. Consult your doctor for details and to discuss effective forms of birth control.

It is unknown if this drug passes into breast milk. Do not breastfeed while using this drug and for 3 months after treatment.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• "statins" (such as atorvastatin, simvastatin)

Other medications can affect the removal of trabectedin from your body, thereby affecting how trabectedin works. These drugs include azole antifungals (such as fluconazole, ketoconazole), macrolide antibiotics (such as clarithromycin), HIV drugs (such as nelfinavir), rifamycins (such as rifabutin), ritonavir, St. John's wort, and some drugs used to treat seizures (such as carbamazepine, phenobarbital, primidone), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, kidney/liver/heart/muscle function) must be done before and while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.