b'FOR USE WITHVeterans Administration& Department of DefenseActor portrayal For more information, visit ONIVYDEinfo.comWARNINGS AND PRECAUTIONS(continued) hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemiaEmbryo-Fetal Toxicity: ONIVYDE can cause fetal harm when administered(35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia to a pregnant woman. Advise females of reproductive potential to use(29%), and hyponatremia (27%)effective contraception during and for 1 month after ONIVYDE treatment DRUG INTERACTIONS ADVERSE REACTIONSAvoid the use of strong CYP3A4 inducers, if possible, and substituteThe most common adverse reactions (20%) were diarrhea (59%),non-enzyme inducing therapies 2 weeks prior to initiation of ONIVYDEfatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and appetite (44%), stomatitis (32%), and pyrexia (23%) discontinue strong CYP3A4 inhibitors 1 week prior to starting therapy The most common Grade 3/4 adverse reactions (10%) were diarrheaUSE IN SPECIFIC POPULATIONS(13%), fatigue/asthenia (21%), and vomiting (11%)Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS .Adverse reactions led to permanent discontinuation of ONIVYDE inAdvise males with female partners of reproductive potential to use condoms 11% of patients receiving ONIVYDE/5-FU/LV; The most frequentduring and for 4 months after ONIVYDE treatmentadverse reactions resulting in discontinuation of ONIVYDE were Lactation: Advise nursing women not to breastfeed during and for 1 month diarrhea, vomiting, and sepsis after ONIVYDE treatment Dose reductions of ONIVYDE for adverse reactions occurred in 33% of patients receiving ONIVYDE/5-FU/LV; the most frequent adverseTo report SUSPECTED ADVERSE REACTIONS, contact reactions requiring dose reductions were neutropenia, diarrhea, nausea,Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at and anemia 1-800-FDA-1088 or www.fda.gov/medwatch. ONIVYDE was withheld or delayed for adverse reactions in 62% ofReferences: 1. Ipsen data on file: IQVIA medical claims post-gemcitabine usage analysis, June patients receiving ONIVYDE/5-FU/LV; the most frequent adverse2018-October 2020. 2. ONIVYDE [package insert]. Basking Ridge, NJ. Ipsen Biopharmaceuticals, reactions requiring interruption or delays were neutropenia, diarrhea,Inc.; 2017. 3. Abrams TA, Meyer G, Meyerhardt JA, Wolpin BM, Schrag D, Fuchs CS. Patterns of chemotherapy use in U.S.-based cohort of patients with metastatic pancreatic cancer. Oncologist. fatigue, vomiting, and thrombocytopenia 2017;22(8):925-933. 4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)The most common laboratory abnormalities (20%) were anemiafor Pancreatic Adenocarcinoma V.2.2021.National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed April 19, 2021. To view the most recent and complete version of the (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%),guideline, go online to NCCN.org.'