This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.
Background and Date of Approval
Trabectedin is an anticancer drug that belongs to the class of alkylating agents. FDA approved Trabectedin on October 23, 2015, for treating advanced soft tissue sarcoma.
Mechanism of Action of undefined
Trabectedin is an alkylating agent, that causes a disruption in the tumor cell cycle and cell death by initiating a cascade of events triggered by the binding of certain nucleobases in the DNA preventing the multiplication of tumor cells. It works by slowing or stopping the growth of cancer cells in the body.
Uses of undefined
Trabectedin is an intravenously administered drug. It is used to treat liposarcoma (a type of cancer that starts in fat cells) or leiomyosarcoma (cancer that begins in smooth muscle tissue) that has spread to other parts of the body and cannot be treated with surgery in individuals who have already received treatment with certain anti-cancer medications. It is also indicated to treat ovarian cancer that has reoccurred after at least 1 previous therapy and not responding to other treatments.
undefined Drug administaration and Dosage available
Trabectedin is available as 1mg injection. It will be given to you by a doctor or nurse in a hospital or clinic setting trained in cancer chemotherapy. It is given as an intravenous infusion drip (into your vein). Do not self-administer the injection. Your doctor will decide the dose and duration of the treatment based on your disease severity, body weight, and other factors. Your doctor will give you certain medications to lessen the chance of getting side effects from the Trabectedin treatment.
Warnings, Precautions and Side Effects of undefined
This drug is intended to cause a severe decrease in white blood cell counts. Monitor complete blood count and other laboratory parameters regularly. Rhabdomyolysis (muscle tissue breakdown) may occur with this medicine; inform your physician if you experience any symptoms of muscle pain and other symptoms. This medicine may cause liver toxicity, and cardiac problems on long-term use. This medicine should not be given during pregnancy because it can cause severe birth defects.
Inform your physician if you have an active infection or have suffered from any infections, liver disease, kidney problems, or heart diseases. This medicine may impair fertility; discuss with your doctor before planning for pregnancy. Do not take Trabectedin if you are allergic to Trabectedin or any other ingredients of this medicine, if you have serious infections, if you are breastfeeding, and if you will receive a yellow fever vaccine. Report to your physician if you face any symptoms of sudden difficulty in breathing, fever, redness or flushing of the skin, or a rash, nausea, or vomiting after administering the injection. Trabectedin is not recommended for children and young people under 18 years of age. Use an effective method of contraception while being treated with this injection. Avoid pregnancy and breastfeeding during the treatment.
The common side effects of trabectedin include constipation, decrease in appetite, diarrhea, nausea, vomiting, anemia, decreased albumin levels, decreased platelet count, headache, shortness of breath, tiredness. Other serious side effects of trabectedin include heart problems, skin rashes, liver problems, and severe muscle pain.
Word Of Advice
Store Trabectedin in the refrigerator (2°C to 8°C). Do not freeze. Keep the injection away from the reach of children and pets. If you have missed any dosing appointments, inform your doctor and schedule immediately. Trabectedin may interfere with vaccines, inform your physician before taking yellow fever vaccine or any other vaccines. This injection may cause severe birth defects if taken during pregnancy. Female patients with reproductive potential should use effective contraception during the treatment. Male patients with female partners with reproductive potential should use effective birth control methods during the treatment and for at least 5 months after their last dose. Do not breastfeed during treatment with this injection. Your doctor may advise you to take certain tests to check for the effectiveness of the therapy.
Frequently Asked Question
- Yondelis 0.25 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc). www.medicines.org.uk. Revised 2022. Accessed April 28, 2023. https://www.medicines.org.uk/emc/product/6164/smpc
- Yondelis - Trabectedin.; Revised on 2018. Accessed April 28, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s005lbl.pdf
- Demetri et al., Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial, Journal of Clinical Oncology, 2016, 34(8), [ Accessed April 28, 2023], https://ascopubs.org/doi/pdfdirect/10.1200/jco.2015.62.4734
The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.