Hola

Home

 / 

Dosing and Administration

Dosing and Administration

Prior to administration: patients should receive premedication before YONDELIS® infusion

Administer dexamethasone 20 mg intravenously 30 minutes prior to each dose of YONDELIS®.1

YONDELIS® is administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks) until disease progression or unacceptable toxicity.

Extravasation of YONDELIS® resulting in tissue necrosis requiring debridement can occur. Evidence of tissue necrosis can occur more than 1 week after the extravasation. There is no specific antidote for extravasation of YONDELIS®. Administer YONDELIS® through a central venous line. For additional safety considerations, please see the full Prescribing Information.

Abnormal laboratory results or adverse events may require dose modifications1

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.

Recommended Dose Modifications

Laboratory Result or Adverse Reaction

Platelets

Absolute neutrophil count

Total bilirubin

AST or ALT

ALP

Creatine phosphokinase

Other nonhematologic adverse reactions

DELAY Next Dose for Up to 3 Weeks

<100,000 platelets/μL

<1,500 neutrophils/μL

>upper limit of normal

>2.5 times the upper limit of normal

>2.5 times the upper limit of normal

>2.5 times the upper limit of normal

Grades 3 or 4

Laboratory Result or Adverse Reaction

Platelets

Absolute neutrophil count

Total bilirubin

AST or ALT

ALP

Creatine phosphokinase

Other nonhematologic adverse reactions

REDUCE Next Dose by 1 Dose Level for Adverse Reaction(s) During Prior Cycle

<25,000 platelets/μL

<1,000 neutrophils/μL with fever/infection

<500 neutrophils/μL lasting more than 5 days

>upper limit of normal

>5 times the upper limit of normal

>2.5 times the upper limit of normal

>5 times the upper limit of normal

Grades 3 or 4

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase.

Conditions that require permanent discontinuation of YONDELIS®1

  • Persistent adverse reactions requiring a dose delay 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: bilirubin 2 times the upper limit of normal, and AST or ALT 3 times the upper limit of normal, and alkaline phosphatase 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
  • Capillary leak syndrome
  • Rhabdomyolysis
  • Grade 3 or 4 cardiac adverse events (AEs) indicative of cardiomyopathy or for subjects with an LVEF that decreases below the lower limit of normal

LVEF=left ventricular ejection fraction.

Administration1

  • Infuse the reconstituted, diluted solution over 24 hours through a central venous line using an infusion set with a 0.2-micron polyethersulfone (PES) in-line 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

Preparation and Administration Checklist

The purpose of this checklist is to give an overview of the preparation and infusion process for YONDELIS®.

It is not intended to be a comprehensive checklist to cover all clinical scenarios, or a substitute for the healthcare professional’s expertise and clinical judgment. Please refer to the full Prescribing Information for complete preparation and administration instructions.

Assess clinical status

  • In addition to a clinical assessment, it is recommended that laboratory values be monitored before and during administration (complete blood count [CBC] with platelets and absolute neutrophil count, liver function tests, creatine phosphokinase)
  • Assess left ventricular ejection fraction by echocardiogram or multigated acquisition scan before initiation of YONDELIS® and at 2- to 3-month intervals until YONDELIS® is discontinued

For more information, please see the full Prescribing Information.

Premedicate

  • Premedicate with dexamethasone 20 mg intravenously 30 minutes prior to administration

For more information, please see the full Prescribing Information.

Determine dosage

  • In patients with normal bilirubin and AST or ALT ≤2.5 times the upper limit of normal, the recommended dose is 1.5 mg/m2 until disease progression or unacceptable toxicity
    • In patients with moderate hepatic impairment,‡ the recommended dose is 0.9 mg/m2
    • Do not administer YONDELIS® to patients with severe hepatic impairment§
    • Avoid the use of concomitant strong CYP3A inducers and inhibitors

For more information, please see the full Prescribing Information.

Handling YONDELIS®

How supplied

  • YONDELIS® is supplied in a single-dose glass vial containing 1 mg of trabectedin
  • Each outer carton of YONDELIS® contains one vial
  • NDC: 59676-610-01

Storage and handling

Store in a refrigerator at 2°C to 8°C (36°F to 46°F).

YONDELIS® is a cytotoxic drug. Follow applicable special handling and disposal procedures.

YONDELIS® is a cytotoxic drug. Follow applicable special handling and disposal procedures.

Prepare YONDELIS®

  • Using aseptic technique, inject 20 mL of Sterile Water for Injection, USP, into the vial
  • Shake the vial until complete dissolution
  • The reconstituted solution is clear, colorless to pale brownish-yellow, and contains 0.05 mg/mL of trabectedin
  • Inspect for particulate matter and discoloration prior to further dilution
  • Discard vial if particles or discoloration are observed
  • Immediately following reconstitution, withdraw the calculated volume of trabectedin and further dilute in 500 mL of 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP
  • Do not mix YONDELIS® with other drugs
  • Discard any remaining solution within 30 hours of reconstituting the lyophilized powder

YONDELIS® diluted solution is compatible with type I colorless glass vials, polyvinyl chloride (PVC) and polyethylene (PE) bags and tubing, PE and polypropylene (PP) mixture bags, polyethersulfone (PES) in-line filters, titanium, platinum or plastic ports, silicone and polyurethane catheters, and pumps having contact surfaces made of PVC, PE, or PE/PP.

For more information, please see the full Prescribing Information.

Administer

  • Infuse YONDELIS® solution over 24 hours through a central venous line using an infusion set with a 0.2 micron PES in-line filter
  • Complete infusion within 30 hours of initial reconstitution
  • Discard any unused portion of the reconstituted product or of the infusion solution

For more information, please see the full Prescribing Information.

USP=US Pharmacopeia.

Download the YONDELIS® Infusion Checklist for information about YONDELIS® in your practice.

‡

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.

§

Bilirubin levels above 3 times to 10 times the upper limit of normal, and any AST and ALT.

REFERENCE:

  1. YONDELIS® (trabectedin) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

Index

  • Prior to administration: Patients should receive premedication before YONDELIS® infusion
  • Recommended starting dose and schedule
  • Abnormal laboratory results or adverse events may require dose modifications
  • Conditions that require permanent discontinuation of YONDELIS®
  • Administration
  • Preparation and Administration Checklist
  • Handling YONDELIS®

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY INFORMATION

EXPAND Expand isi