Trabectedin Medication Information

Get detailed information on Trabectedin, including pronunciation, uses, dosage guidelines, indications, and instructions on how and when to take it and when to avoid it.

The updated prescription information on Trabectedin provides an overview of possible side effects, precautions, warnings, and storage tips.

You'll also find brand names used in india and internationally, along with pricing details. For further clarification, consult your healthcare provider.

Generic Name : Trabectedin

Pronunciation : tra-BEK-te-din

Therapeutic Classification : Chemotherapy

Trade Names/Brand Names of Trabectedin

India :

Yondelis

Why is Trabectedin Prescribed? (Indications)

Trabectedin is an anticancer medicine prescribed to treat advanced soft tissue sarcoma such as liposarcoma, a cancer of fat cells and leiomyosarcoma, a cancer of smooth muscle tissue.

It is used in patients whose cancer cells have spread to other body parts or who cannot be treated with surgery, and who have shown treatment failure with other cancer medications or cannot take similar drugs.

Trabectedin is an alkylating-type cancer agent that works by attaching a chemical group to cellular DNA and stopping or slowing down the growth and multiplication of cancer in the body.

It is also recommended to treat patients with a history of recurrence or worsening of platinum-sensitive ovarian cancer.

When should Trabectedin not be taken? (Contraindications)

Trabectedin should not be used in patients-

• Allergic to trabectedin
• Pregnancy and breastfeeding
• Children
• Undergoing treatment for infertility
• High levels of creatine phosphokinase

Caution is required while treating patients with-

• Liver disorder
• Abnormal heart function
• Kidney disease

What is the dosage of Trabectedin?

• The dose is calculated based on the patient’s body surface area.

• The recommended dose of trabectedin is 1.5mg/m² given for every three weeks or 21 days up until any disease progression or drug toxicity.

• Patients who are given trabectedin should have normal levels of bilirubin, and the liver enzymes such as AST (SGOT) and ALT (SGPT) should be less than or equal to 2.5 times the standard limit.

• Injection of dexamethasone 20 mg should be given 30 minutes before starting trabectedin infusion to avoid specific side effects such as liver toxicity and vomiting caused by trabectedin.

• The dose of trabectedin can be adjusted based on the side effects that occur during trabectedin treatment, and if reduced should not be increased in the following treatment cycles.

• The dose of trabectedin can be reduced to 1.2 mg/m² for every three weeks and if side effects tend to occur, the dose can further be reduced to 1 mg/m² for every three weeks.

• Combination of trabectedin with other drugs should not be used if the creatinine clearance is less than 60 mL/min; monotherapy of trabectedin should not be given if the creatinine clearance is less than 30mL/min.

How should Trabectedin be taken?

• Trabectedin injection should be given directly into the vein through a separate central venous line very slowly for 24 hours.

• Trabectedin powder for reconstitution should be mixed with 20 ml of sterile water of injection, and further diluted with 500 ml of 0.9% sodium chloride or 5% dextrose.

• Do not mix other drugs with trabectedin injection.

• Use the trabectedin solution within 30 hours from the time of reconstitution and discard any unused or remaining solution.

• Trabectedin vials should be checked for any discoloration or presence of visible particles before administering, and if any such things are seen, the vial should be discarded.

What are the warnings and precautions for Trabectedin?

• Neutropenic sepsis can occur during the treatment with trabectedin and patients must get their levels of neutrophils assessed before taking trabectedin and in between the treatment cycles.

• Screen for neutrophil counts before initiating treatment with trabectedin and reduce the dose permanently if severe neutropenia or abnormally low levels of neutrophils are found.

• Trabectedin can cause rhabdomyolysis or damage to the muscle and patients should check their levels of creatine phosphokinase before each administration of trabectedin.

• Treatment with trabectedin should be temporarily stopped if the creatine phosphokinase levels are more than 2.5 times the normal level. If rhabdomyolysis occurs, treatment should be permanently stopped.

• Liver function tests should be done each time before giving trabectedin injection as toxicity of the liver including liver failure can occur during the treatment.

• Dose reduction, withholding the treatment temporarily or permanent discontinuation can be chosen depending on the abnormalities of liver function.

• Heart parameters should be examined by taking ECG or multigated acquisition (MUGA) scan before starting trabectedin treatment and in 2 to 3 months intervals until trabectedin therapy is stopped.

• Women of childbearing age should take an effective contraceptive measure during trabectedin treatment and should continue contraception for at least two months after the last dose of trabectedin to avoid pregnancy, which may result in fetal harm if any effects of trabectedin linger.

• Men living with a reproductive potential female partner should follow proper contraception during the treatment and for at least five months after stopping to take trabectedin.

• Leakage of trabectedin outside the vein or into the skin known as extravasation may occur and result in the death of nearby tissues; if so, the dead tissues have to be surgically removed to protect other healthy tissues.

What are the side effects of Trabectedin?

Gastrointestinal: Loose stools, nausea, vomiting, loss of appetite, constipation
Nervous system: Headache, sleeping difficulty, pricking, numbness or burning sensation, general weakness
Respiratory: Breathing difficulty, chest pain, coughing up blood
Skin: Redness, swelling, pain at the injection site
Others: Muscle weakness, joint pain, edema or fluid accumulation, lab abnormalities of creatine phosphokinase, neutrophils, platelets, liver enzymes, bilirubin, and albumin

What are the other precautions for Trabectedin?

• Breastfeeding should be stopped during trabectedin treatment and children should not be breastfed for at least three months from the last dose of trabectedin.

• Avoid alcohol consumption as it may further worsen the liver toxicity caused by trabectedin.

What are the Drug Interactions of Trabectedin?

The following drugs can increase the availability of trabectedin causing toxicity and leading to severe side effects.

• Antifungal drugs (e.g., Ketoconazole, Voriconazole, Itraconazole)
• Antibiotics (e.g., Telithromycin, Clarithromycin)
• Antiviral drugs (e.g., Ritonavir, Nelfinavir, Saquinavir)
• Antidepressant (e.g., Nefazodone)
• Conivaptan

The above drugs should be taken either one week after trabectedin infusion or stopped one day before trabectedin infusion.

Drugs such as phenobarbital and rifampin may decrease the effect of trabectedin which may result in treatment failure or recurrence of the disease symptoms.

Grapefruit juice or grapefruit and herbal supplements such as St. John’s Wort should not be taken along with trabectedin to avoid life-threatening side effects.

What are the storage conditions for Trabectedin?

• Store trabectedin vials in a refrigerator between 2°C and 8°C.

• Do not keep in a freezer.

• Trabectedin is a cytotoxic drug that requires safe handling and disposal of used vials, syringes, and IV set to avoid leakage or spill.