Prior to administration: patients should receive premedication before YONDELIS® infusion
Administer dexamethasone 20 mg intravenously 30 minutes prior to each dose of YONDELIS®.1
Administer dexamethasone 20 mg intravenously 30 minutes prior to each dose of YONDELIS®.1
The recommended dose is 1.5 mg/m2 administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks), until disease progression or unacceptable toxicity.
Moderate hepatic impairment:
The recommended dose is 0.9 mg/m2 in patients with 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
Severe hepatic impairment:
Do not administer to patients with bilirubin levels above 3 times the upper limit of normal, and any AST and ALT
ALT = alanine aminotransferase; AST = aspartate aminotransferase.
The recommended starting doses and dose reductions for YONDELIS® are listed in the table below.1
Recommended Starting Doses and Dose Reductions | ||
---|---|---|
Starting Dose and Dose Reduction |
For patients with normal hepatic function or mild hepatic impairment* |
For patients with moderate hepatic impairment† prior to initiation of YONDELIS® treatment |
Starting dose | 1.5 mg/m2 | 0.9 mg/m2 |
Dose reduction | ||
First dose reduction | 1.2 mg/m2 | 0.6 mg/m2 |
Second dose reduction | 1.0 mg/m2 | 0.3 mg/m2 |
Recommended Starting Doses and Dose Reductions | |
---|---|
Starting Dose and Dose Reduction |
For patients with normal hepatic function or mild hepatic impairment* |
Starting Dose | 1.5 mg/m2 |
Dose Reduction | |
First dose reduction | 1.2 mg/m2 |
Second dose reduction | 1.0 mg/m2 |
Starting Dose and Dose Reduction |
For patients with moderate hepatic impairment prior to initiation of YONDELIS® treatment |
Starting Dose | 0.9 mg/m2 |
Dose Reduction | |
First dose reduction | 0.6 mg/m2 |
Second dose reduction | 0.3 mg/m2 |
*Including patients with bilirubin 1 to 1.5 times the upper limit of normal, and any AST or ALT.
†Including patients with bilirubin levels greater than 1.5 times to 3 times the upper limit of normal, and AST and ALT less than 8 times the upper limit of normal.
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 |
DELAY Next Dose for Up to 3 Weeks |
REDUCE Next Dose by 1 Dose Level for Adverse Reaction(s) During Prior Cycle |
Platelets | <100,000 platelets/microliter | <25,000 platelets/microliter |
Absolute neutrophil count | <1,500 neutrophils/microliter |
• <1000 neutrophils/microliter with fever/infection • <500 neutrophils/microliter lasting more than 5 days |
Total bilirubin | >upper limit of normal | >upper limit of normal |
AST or ALT | >2.5 times the upper limit of normal | >5 times the upper limit of normal |
ALP | >2.5 times the upper limit of normal | >2.5 times the upper limit of normal |
Creatine phosphokinase | >2.5 times the upper limit of normal | >5 times the upper limit of normal |
Other nonhematologic adverse reactions | Grades 3 or 4 | Grades 3 or 4 |
Recommended Dose Modifications | |
---|---|
Laboratory Result or Adverse Reaction |
DELAY Next Dose for Up to 3 Weeks |
Platelets | <100,000 platelets/microliter |
Absolute neutrophil count | <1,500 neutrophils/microliter |
Total bilirubin | > upper limit of normal |
AST or ALT | >2.5 times the upper limit of normal |
ALP | >2.5 times the upper limit of normal |
Creatine phosphokinase | >2.5 times the upper limit of normal |
Other & non-hematologic adverse reactions | Grades 3 or 4 |
Laboratory Result or Adverse Reaction |
REDUCE next dose by 1 Dose level for Adverse Reaction(s) during prior cycle |
Platelets | <25,000 platelets/microliter |
Absolute neutrophil count |
• <1000 neutrophils/microliter with fever/infection • <500 neutrophils/microliter lasting more than 5 days |
Total bilirubin† | >upper limit of normal |
AST or ALT† | >5 times the upper limit of normal |
ALP† | >2.5 times the upper limit of normal |
Creatine phosphokinase | >5 times the upper limit of normal |
Other nonhematologic adverse reactions | Grades 3 or 4 |
ALP = alkaline phosphatase.
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. YONDELIS® may be administered to inpatients or outpatients, via stationary or ambulatory pump, at the physician’s discretion. 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®. For additional safety considerations, please see the full Prescribing Information.
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.
For more information, please see the full Prescribing Information.
For more information, please see the full Prescribing Information.
For more information, please see the full Prescribing Information.
For more information, please see the full Prescribing Information.
For more information, please see the full Prescribing Information.
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.
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