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Dosing and Administration

YONDELIS® injection for intravenous infusion

Premedication

  • Administer dexamethasone 20 mg intravenously 30 minutes prior to each dose of YONDELIS®

Dose modifications

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/m2 for 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.

Criteria for Treatment With YONDELIS® on Day 1 of Each Treatment Cycle
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* Permanently discontinue YONDELIS® when liver dysfunction is exacerbated for patients with pre-existing moderate hepatic impairment. The recommended starting doses and dose reductions for YONDELIS® are listed in the table below. Criteria for Treatment With YONDELIS® on Day 1 of Each Treatment Cycle
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Including patients with bilirubin 1 to 1.5 times the upper limit of normal, and any AST or ALT.

Administration

  • 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

Other considerations

An ambulatory pump may be used for administration at the discretion of the physician.

INDICATION

YONDELIS® (trabectedin) is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

 

Important Safety Information

 

Indication

INDICATION

YONDELIS® (trabectedin) is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

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