Effective January 1, 2017 - New permanent J-code for ONIVYDE®: J9205, injection, irinotecan liposome, 1 mg This information is presented for informational purposes only and is not intended to provide reimbursement or legal advice.

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Dose Modifications for Patient Management1

The Dose Modification Recommendations for ONIVYDE® (irinotecan liposome injection) are Designed to Enable Management of Most Grade 3 or 4* Adverse Reactions

Recommended Dose Modifications for ONIVYDE® (70 mg/m2) (50 mg/m2)
Toxicity
NCI CTCAE v4.0*
Directions ONIVYDE® adjustment
in patients receiving
70 mg/m2
Patients homozygous for UGT1A1*28
(who are currently receiving 50 mg/m2)
Grade 2
Diarrhea
Withhold ONIVYDE®.
Administer loperamide for late-onset diarrhea of any severity. Administer atropine, if not contraindicated, for early-onset diarrhea of any severity.
N/A N/A
Grade 3 or 4
Diarrhea
Withhold ONIVYDE®.
Initiate loperamide for late-onset diarrhea of any severity. Administer intravenous or subcutaneous atropine 0.25 mg to 1 mg (unless clinically contraindicated) for early-onset diarrhea of any severity. Upon recovery to ≤Grade 1 diarrhea, resume ONIVYDE® at a modified dose.
First Occurrence
50 mg/m2
First Occurrence
43 mg/m2
Second Occurrence
43 mg/m2
Second Occurrence
35 mg/m2
Third Occurrence
Discontinue
ONIVYDE®
Third Occurrence
Discontinue
ONIVYDE®
Grade 3 or 4 Adverse Reactions Withhold ONIVYDE®. Upon recovery to ≤Grade 1, resume ONIVYDE® at a modified dose. First Occurrence
50 mg/m2
First Occurrence
43 mg/m2
Second Occurrence
43 mg/m2
Second Occurrence
35 mg/m2
Third Occurrence
Discontinue
ONIVYDE®
Third Occurrence
Discontinue
ONIVYDE®
Interstitial Lung Disease First Occurrence Discontinue ONIVYDE® First Occurrence Discontinue ONIVYDE®
Anaphylactic Reaction First Occurrence Discontinue ONIVYDE® First Occurrence Discontinue ONIVYDE®

*National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 used for grading.

In the clinical study when ONIVYDE® was withheld or discontinued for adverse reactions, 5-FU was also withheld or discontinued. When the dose of ONIVYDE® was reduced for adverse reactions, the dose of 5-FU was reduced by 25%.

For recommended dose modifications of 5-FU or LV, refer to the respective full Prescribing Information (PI).

Management of Severe Neutropenia1

  • Monitor complete blood cell counts on Days 1 and 8 of every cycle and more frequently if clinically indicated
  • Withhold ONIVYDE® for absolute neutrophil count below 1500/mm3 or neutropenic fever
  • Upon recovery to ANC ≥1500/mm3, reduce ONIVYDE® dose for Grade 3–4 neutropenia or neutropenic fever
  • Special Considerations:
    • Grade 3 or 4 neutropenia was higher among Asian patients (18 of 33 [55%]) compared to White patients (13 of 73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of Asian patients compared to 1% of White patients

Management of Severe Diarrhea1

  • Severe or life-threatening diarrhea followed 1 of 2 patterns:
    • Late-onset diarrhea (onset more than 24 hours following chemotherapy); and
    • Early-onset diarrhea (onset within 24 hours of chemotherapy, sometimes occurring with other symptoms of cholinergic reaction)
    • An individual patient may experience both early- and late-onset diarrhea
  • Withhold ONIVYDE® for diarrhea of Grade 2–4 severity
  • Administer loperamide for late-onset diarrhea of any severity; 34% of patients received loperamide for late-onset diarrhea
  • Administer atropine for early-onset diarrhea of any severity; 26% of patients received atropine for early-onset diarrhea
  • Following recovery to Grade 1 diarrhea, resume ONIVYDE® at a reduced dose
11%
Discontinued
Adverse reactions leading to permanent discontinuation of ONIVYDE® included diarrhea, vomiting, and sepsis.
33%
Dose reduced
Adverse reactions leading to dose reductions of ONIVYDE® were neutropenia, diarrhea, nausea, and anemia.
62%
Withheld or Delayed
Adverse reactions leading to withholding or delaying ONIVYDE® were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia.

INDICATION AND IMPORTANT SAFETY INFORMATION

**National Comprehensive Cancer Network® (NCCN®).

Reference: 1. ONIVYDE® Full Prescribing Information.

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INDICATION AND IMPORTANT
SAFETY INFORMATION