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])

ONIVYDE
+ 5-FU/LV
n=117
5-FU/LV
n=134
Grades
1–4 (%)
Grades
3–4 (%)
Grades
1–4 (%)
Grades
3–4 (%)
Gastrointestinal disorders
Diarrhea 59 13 26 4
Diarrhea, early 30 3 15 0
Diarrhea, late 43 9 17 4
Vomiting 52 11 26 3
Nausea 51 8 34 4
Stomatitis§ 32 4 12 1
Infections and infestations 38 17 15 10
Sepsis 4 3 2 1
Neutropenic fever/
neutropenic sepsis||
3 3 1 0
Gastroenteritis 3 3 0 0
Intravenous catheter-
related infection
3 3 0 0
General disorders and administration site conditions
Fatigue/
asthenia
56 21 43 10
Pyrexia 23 2 11 1
Metabolism and nutrition disorders
Decreased appetite 44 4 32 2
Weight loss 17 2 7 0
Dehydration 8 4 7 2
Skin and subcutaneous tissue disorders
Alopecia 14 1 5 0

*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])

ONIVYDE
+ 5-FU/LV
n=117
5-FU/LV
n=134
Grades
1–4 (%)
Grades
3–4 (%)
Grades
1–4 (%)
Grades
3–4 (%)
Hematology
Anemia 97 6 86 5
Lymphopenia 81 27 75 17
Neutropenia 52 20 6 2
Thrombocytopenia 41 2 33 0
Hepatic
Increased alanine
aminotransferase (ALT)
51 6 37 1
Hypoalbuminemia 43 2 30 0
Metabolic
Hypomagnesemia 35 0 21 0
Hypokalemia 32 2 19 2
Hypocalcemia 32 1 20 0
Hypophosphatemia 29 4 18 1
Hyponatremia 27 5 12 3
Renal
Increased creatinine 18 0 13 0

*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