Drug information of trabectedine


Mechanism of effect

Trabectedin is a marine-derived compound (alkylating agent) which blocks the cell cycle at the G2/M phase by covalently binding to the minor DNA groove, bending the helix toward the major groove and altering DNA transcription .

 Affects activity of DNA binding proteins, transcription factors and DNA repair mechanism, leading to cell death.



Vdss: >5,000 L


Extensively hepatic; via CYP3A4


Feces (58%; only negligible amounts as unchanged drug); urine (6%; only negligible amounts as unchanged drug)

Half-Life Elimination:

~175 hours

Protein Binding:

~97%; to plasma proteins

Drug indications

 Labeled Indications

Soft tissue sarcoma: Treatment of unresectable or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) in patients who have received a prior anthracycline-containing regimen.

Off Label Uses:

Ovarian cancer, relapsed (platinum sensitive)

Data from a phase III study support the use of trabectedin (in combination with doxorubicin liposomal) in the treatment of recurrent, platinum-sensitive ovarian cancer in patients with a platinum-free interval of 6 to 12 months (based on a subgroup analysis)



Soft tissue sarcoma, unresectable/metastatic:

 IV: 1.5 mg/m2 as a continuous infusion over 24 hours once every 3 weeks; continue until disease progression or unacceptable toxicity .

Ovarian cancer, relapsed, platinum sensitive (off-label use): IV: 1.1 mg/m2 over 3 hours every 3 weeks (in combination with doxorubicin liposomal), continue as long as clinical benefit is demonstrated or until disease progression or confirmed complete response or for 2 or more cycles beyond complete response . Delay treatment and/or reduce the trabectedin dose (to 0.9 mg/m2, then to 0.75 mg/m2) for toxicities (doxorubicin liposomal may also require modification), consider discontinuing if a second dose reduction is not tolerated .

Drug contraindications


Side effects

Along with its needed effects, trabectedin 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 while taking trabectedin:

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


  • 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 of trabectedin 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

 bcg , bcg vaccine  ,  trivalent , poliovirus vaccine,  ,  smallpox vaccine

Points of recommendation

Trabectedin affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, mouth sores, skin sores, sore throat, cough, or trouble breathing.

You should not be treated with trabectedin if you are allergic to it.

Tell your doctor if you have ever had:

  • liver disease;
  • heart disease; or
  • kidney disease.

Trabectedin can harm an unborn baby or cause birth defects if the mother or the father is taking trabectedin.

If you are a woman, do not use trabectedin if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose.


If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 5 months after your last dose.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using trabectedin.

Before you receive a dose of trabectedin, you may need a blood test to check your liver function.

Trabectedin is given as an infusion into a vein, through a central line IV. A healthcare provider will give you this injection.

Trabectedin must be given slowly and the infusion can take up to 24 hours to complete.

Trabectedin is usually given once every 3 weeks. Your doctor will determine how long to treat you with trabectedin.

You may be given steroid medication to prevent certain side effects of trabectedin.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when trabectedin is injected.

Trabectedin affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.


Store intact vials at 2°C to 8°C (36°F to 46°F). Solutions diluted for infusion in NS or D5W should be used within 30 hours of reconstitution (infusion should be completed within that 30 hours).

Pregnancy level


US FDA pregnancy category: Not Assigned

Breast feeding warning

Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments: The effects in the nursing infant and on milk production are unknown.

Drug forms


Ask a Pharmacist

User's questions
    No comments yet.