YONDELIS® injection for intravenous infusion
Recommended dose and schedule
- The recommended dose for YONDELIS® (trabectedin) is 1.5 mg/m2 administered as an intravenous infusion over 24 hours through a central venous line once every 21 days (3 weeks), until disease progression or unacceptable toxicity, in patients with normal bilirubin and AST or ALT ≤2.5 times the upper limit of normal
- Hepatic impairment: The recommended dose is 0.9 mg/m2 in patients with moderate hepatic impairment (bilirubin levels 1.5 times to 3 times the upper limit of normal, and AST and ALT less than 8 times the upper limit of normal). Do not administer YONDELIS® to patients with severe hepatic impairment (bilirubin levels above 3 times to 10 times the upper limit of normal, and any AST and ALT)
- Administer dexamethasone 20 mg intravenously 30 minutes prior to each dose of YONDELIS®
Permanently discontinue YONDELIS® for:
- Persistent adverse reactions requiring a delay in dosing of more than 3 weeks
- Adverse reactions requiring dose reduction following YONDELIS® administered at 1.0 mg/m2 for patients with normal hepatic function or at
0.3 mg/m2for patients with pre-existing moderate hepatic impairment
- Severe liver dysfunction (all of the following: bilirubin 2 times the upper limit of normal and AST or ALT 3 times the upper limit of normal with ALP less than 2 times the upper limit of normal) in the prior treatment cycle for patients with normal liver function at baseline
- Exacerbation of liver dysfunction in patients with pre-existing moderate hepatic impairment
The recommended dose modifications for adverse reactions are listed in the table below. Once reduced, the dose of YONDELIS® should not be increased in subsequent treatment cycles.
- Infuse the reconstituted, diluted solution over 24 hours through a central venous line using an infusion set with a 0.2-micron polyethersulfone (PES) inline filter to reduce the risk of exposure to adventitious pathogens that may be introduced during solution preparation
- Complete infusion within 30 hours of initial reconstitution. Discard any unused portion of the reconstituted product or of the infusion solution
An ambulatory pump may be used for administration at the discretion of the physician.