Pronunciation:

tra-BEK-te-din

Brand Names:

• Yondelis

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Trabectedin injection is used to treat certain types of cancer, including liposarcoma or leiomyosarcoma that cannot be treated with surgery or has spread to other parts of the body. It is used in patients who have received treatment with other medicines.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of trabectedin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of trabectedin injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Boceprevir
• Carbamazepine
• Cholera Vaccine, Live
• Clarithromycin
• Cobicistat
• Conivaptan
• Dengue Tetravalent Vaccine, Live
• Fedratinib
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Indinavir
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Lopinavir
• Mavacamten
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Nefazodone
• Nelfinavir
• Netupitant
• Omaveloxolone
• Phenobarbital
• Phenytoin
• Poliovirus Vaccine, Live
• Posaconazole
• Primidone
• Rifampin
• Ritonavir
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Saquinavir
• Smallpox Vaccine
• St John's Wort
• Telaprevir
• Telithromycin
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Voriconazole
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease (eg, cardiomyopathy) or
• Heart failure or
• Liver disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine must be given slowly, so the needle will remain in place for 24 hours. You may also receive medicines to help prevent possible allergic reactions to the injection.

This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 2 months after your last dose. Men receiving this medicine should use condoms or other birth control forms during treatment and for at least 5 months after your final dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Check with your doctor if you notice any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts.

Rhabdomyolysis may occur while receiving this medicine. Tell your doctor if you have severe muscle, bone, or joint pain after receiving this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Call your doctor right away if you have chest pain, trouble breathing, swelling in your ankles or feet, or fast or irregular heartbeat. These maybe symptoms of cardiomyopathy.

Tell your doctor right away if you have redness, swelling, or pain at the injection site after receiving this medicine.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chest discomfort or pain

difficulty breathing

dizziness

faintness

fast irregular or pounding heartbeat

swelling of the feet or lower legs

unusual tiredness or weakness

Less common

Dark-colored urine

fever

muscle cramps or spasms

muscle pain or stiffness

Rare

Abdominal or stomach pain or tenderness

clay colored stools

decreased appetite

headache

itching or skin rash

loss of appetite

nausea and vomiting

swelling of the feet or lower legs

yellow eyes or skin

Incidence not known

Black, tarry stools

chills

cough

difficulty with swallowing

hives

lower back or side pain

painful or difficult urination

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sore throat

tightness in the chest

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

difficulty having a bowel movement (stool)

decreased appetite

headache

trouble sleeping

Incidence not known

Pain at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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