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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Adverse Reactions1

Adverse Reactions Occurring at a Higher Incidence in the ONIVYDE® (irinotecan liposome injection) + 5-FU/LV Arm Than in the 5-FU/LV Arm (Between-arm Difference of ≥5% [Grades 1–4]* or ≥2% [Grades 3 and 4])

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

Early diarrhea: onset ≤24 hours of ONIVYDE® administration.

Late diarrhea: onset >1 day after ONIVYDE® administration.

§Includes stomatitis, aphthous stomatitis, mouth ulceration, mucosal inflammation.

||Includes febrile neutropenia.

5-FU=fluorouracil; LV=leucovorin.

Laboratory Abnormalities1

Laboratory Values Occurring at a Higher Incidence in the ONIVYDE® (irinotecan liposome injection) + 5-FU/LV Arm Than in the 5-FU/LV Arm (Between-arm Difference of ≥5% [Grades 1–4]* or ≥2% [Grades 3 and 4])

C

*National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, worst grade shown.

Percent based on number of patients with a baseline and at least one post-baseline measurement.

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