Recommended dosing per NAPOLI-1 protocol1


Administer ONIVYDE® prior to leucovorin and 5-FU1

In the NAPOLI-1 trial1,4:

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  • Treatment continued until disease progression or unacceptable toxicity
  • The median duration of therapy in the ONIVYDE® + 5-FU/LV arm was 9 weeks

The recommended starting dose of ONIVYDE® in patients known to be homozygous for the UGT1A1*28 allele is 50 mg/m2 administered by IV infusion over 90 minutes. Increase the dose of ONIVYDE® to 70 mg/m2, as tolerated, in subsequent cycles.1

There is no recommended dose of ONIVYDE® for patients with serum bilirubin above the upper limit of normal.1

Important Dosing Information

  • Do not substitute ONIVYDE® for other drugs containing irinotecan hydrochloride
  • Premedicate with a corticosteroid and an anti-emetic 30 minutes prior to ONIVYDE® infusion
  • Monitor complete blood cell counts on Days 1 and 8 of every cycle and more frequently if clinically indicated
  • Avoid the use of strong CYP3A4 inducers if possible; substitute non-enzyme inducing therapies at least 2 weeks prior to initiation of ONIVYDE®
  • Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible; discontinue strong CYP3A4 inhibitors at least 1 week prior to starting therapy