When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to trabectedin, or if you are pregnant or breastfeeding.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how trabectedin works. Tell your doctor if you are using boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, phenobarbital, posaconazole, rifampin, ritonavir, saquinavir, St John's wort, telaprevir, telithromycin, or voriconazole.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment and for at least 2 months after your last dose. Men who are receiving this medicine should use effective birth control during treatment and for at least 5 months after your final dose.
• Tell your doctor if you have kidney disease, liver disease, or heart disease.
• This medicine may cause the following problems:
  
  • Severely low white blood cells counts, which may lead to serious or life-threatening infection
  • Rhabdomyolysis (severe muscle problem)
  • Liver damage
  • Damage to the heart muscle, heart failure
  • Damage to the skin around the injection site
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, and body aches
• Pain, itching, burning, swelling, or redness where the needle is placed
• Rapid weight gain, swelling in your hands, ankles, or feet, chest pain, trouble breathing, unusual tiredness
• Severe muscle pain, tenderness, or weakness
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Loss of appetite
• Nausea, vomiting, constipation, diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088