Well-characterized Safety Profile1

Napoli-1: Adverse Reactions1

ADVERSE REACTIONS OCCURRING AT A HIGHER INCIDENCE IN THE ONIVYDE® + 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
Diarrhea5913264
Diarrhea, early303150
Diarrhea, late439174
Vomiting5211263
Nausea518344
Stomatitis§324121
Infections and infestations38171510
Sepsis4321
Neutropenic fever/neutropenic sepsis||3310
Gastroenteritis3300
Intravenous catheter-related infection3300
General disorders and administration site conditions
Fatigue/asthenia56214310
Pyrexia232111
Metabolism and nutrition disorders
Decreased appetite444322
Weight loss17270
Dehydration8472
Skin and subcutaneous tissue disorders
Alopecia14150
  • Discontinuation rate due to adverse reactions was 11%1
  • There were no overall differences in safety observed between younger (<65 years) and older patients (65 years)1
  • The most common serious adverse reactions (2%) of ONIVYDE®, alone or in combination, were diarrhea, vomiting, neutropenic fever or neutropenic sepsis, nausea, pyrexia, sepsis, dehydration, septic shock, pneumonia, acute renal failure, and thrombocytopenia1

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

Early diarrhea: onset 24 hours after ONIVYDE® administration.

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

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

||Includes febrile neutropenia.

portrait

NAPOLI-1: LABORATORY ABNORMALITIES1

Laboratory abnormalities occurring at a higher incidence in the ONIVYDE® + 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
Anemia976865
Lymphopenia81277517
Neutropenia522062
Thrombocytopenia412330
Hepatic
Increased alanine aminotransferase (ALT)516371
Hypoalbuminemia432300
Metabolic
Hypomagnesemia350210
Hypokalemia322192
Hypocalcemia321200
Hypophosphatemia294181
Hyponatremia275123
Renal
Increased creatinine180130
PLEASE SEE DOSE MODIFICATIONS DESIGNED TO SUPPORT ACTIVE MANAGEMENT OF CERTAIN GRADE 3 OR 4 ADVERSE REACTIONS AND GRADE 2–4 DIARRHEA
National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 used for grading.