Description
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 in patients who have received other cancer medicines (eg, anthracyclines).
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine, Live
- 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 Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Apalutamide
- Avacopan
- Boceprevir
- Carbamazepine
- Cholera Vaccine
- Clarithromycin
- Cobicistat
- Conivaptan
- Ebola Zaire Vaccine, Live
- Fedratinib
- Fosnetupitant
- Fosphenytoin
- Idelalisib
- Indinavir
- Influenza Virus Vaccine, Live
- Itraconazole
- Ketoconazole
- Letermovir
- Lopinavir
- Mifepristone
- Nefazodone
- Nelfinavir
- Netupitant
- Omaveloxolone
- Phenobarbital
- Phenytoin
- Posaconazole
- Primidone
- Ribociclib
- Rifampin
- Ritonavir
- Rotavirus Vaccine, Live
- Saquinavir
- St John's Wort
- Tazemetostat
- Telaprevir
- Telithromycin
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), history of or
- Heart failure or
- Kidney disease or
- Liver disease—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine. It is given through an IV catheter placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 24 hours. The infusion will be given every 21 days (3 weeks).
This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor may also give you other medicines (eg, steroid medicine) 30 minutes before receiving this medicine.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 8 months after your last dose. Males who are taking this medicine with female partners who can become pregnant must use effective birth control during treatment and for 5 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you start to cough up blood or if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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.
This medicine may cause rhabdomyolysis (severe muscle problem). Check with your doctor right away if you have dark-colored urine, fever, muscle cramps, spasms, pain, or stiffness, or unusual tiredness or weakness.
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.
This medicine may cause heart muscle problems, including heart failure. Check with your doctor right away if you have chest discomfort, pain, or tightness, decreased urine output, dizziness, faintness, fast or irregular heartbeat, swelling of the feet or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain.
This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.
This medicine may cause damage to the skin around the injection site. Tell your doctor right away if you have redness, swelling, or pain at the injection site after receiving this medicine.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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
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, pain, spasms, 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
- redness, swelling, or pain at the injection site
- 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
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.
DRG-20165168
