trabectedin: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
trabectedin: clinical details
Prescribing considerations
- Restrict use to clinicians experienced in cytotoxic chemotherapy.
- Confirm adequate haematological, hepatic, renal and creatine phosphokinase results before administration.
- Give corticosteroid antiemetic prophylaxis and strongly favour central venous access.
- Assess cardiac function before treatment, with continued surveillance, particularly after anthracycline exposure or in people with cardiovascular risk.
- Discuss contraception, potential infertility and gamete preservation before treatment where relevant.
Contraindications and cautions
- Hypersensitivity to trabectedin or an excipient
- Concurrent serious or uncontrolled infection
- Breastfeeding
- Concurrent yellow fever vaccination
- Elevated baseline bilirubin or inadequate organ and haematological parameters specified by the product information
Monitoring
- Full blood count with differential and platelets
- Bilirubin, aminotransferases, alkaline phosphatase and albumin
- Creatinine clearance and hydration status
- Creatine phosphokinase, especially with muscle symptoms or interacting medicines
- Cardiac symptoms and left ventricular function
- Infusion site and symptoms of capillary leak syndrome
Clinical pharmacology
Trabectedin binds covalently in the DNA minor groove, affecting transcription, DNA-binding proteins and repair pathways. It is extensively distributed and protein bound, is metabolised mainly through CYP3A4 and has little renal elimination as unchanged medicine.
Formulation and product differences
- The selected product is a white to off-white powder for concentrate that requires aseptic reconstitution and further dilution before intravenous use.
- It is supplied as a single-use vial and contains mannitol, citric acid monohydrate and sodium citrate.
- The selected formulation is considered essentially sodium-free.
trabectedin preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 0.25 mg, 1 mg
trabectedin interactions
The oncology team should review prescribed, over-the-counter and herbal products before treatment.
Potent CYP3A4 inhibitors, including clarithromycin, azole antifungals, ritonavir and aprepitant
May increase trabectedin exposure and toxicity; avoid where possible or monitor closely.
Strong CYP3A4 inducers, including rifampicin, phenobarbital and St John’s wort
May reduce trabectedin exposure and should be avoided where possible.
Phenytoin
Trabectedin may reduce phenytoin absorption and worsen seizure control; the combination is not recommended.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.