b"WHEN METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (mPDAC) PROGRESSES ON GEMCITABINEHELP YOUR PATIENTS FIGHT ONDON'T MISS THE CHANCE TO CONSIDER ONIVYDE + 5-FU/LV, THE #1 PRESCRIBED 2L REGIMEN AND ONLY FDA-APPROVED THERAPY FOR mPDAC PATIENTS AFTER GEMCITABINE 1,2* About half of mPDAC patients who completed 1L treatment may be eligible for active 2L treatment 3Dont wait if a change in therapy is required, since patients with metastatic pancreaticadenocarcinoma may have abrupt changes in clinical status 4PROVEN TO EXTEND OVERALL SURVIVAL 2Median 6.1 months for ONIVYDE + 5-FU/LV (95% CI: 4.8, 8.5) vs 4.2 months for 5-FU/LV alone (95% CI: 3.3, 5.3); HR=0.68 [95% CI: 0.50, 0.93]; log-rank P=0.014: a 32% reduction in risk of death 2The most common serious adverse reactions (2%) of ONIVYDE were diarrhea, vomiting, neutropenic fever or neutropenic sepsis, nausea, pyrexia, sepsis, dehydration, septic shock, pneumonia, acute renal failure, and thrombocytopenia 2*Based on metastatic pancreatic cancer patients who have had at least 3 cycles of a gemcitabine-based regimen and did not have pancreatic cancer-related activity for 60 days prior to beginning an ONIVYDE treatment regimen. 5-FU=fluorouracil; LV=leucovorin.INDICATION CONTRAINDICATIONONIVYDE (irinotecan liposome injection) is indicated, in combinationONIVYDE is contraindicated in patients who have experienced a with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patientssevere hypersensitivity reaction to ONIVYDE or irinotecan HClwith metastatic adenocarcinoma of the pancreas after disease progressionWARNINGS AND PRECAUTIONSfollowing gemcitabine-based therapy. Limitation of Use: ONIVYDE is notSevere Neutropenia: See Boxed WARNING. In patients receiving indicated as a single agent for the treatment of patients with metastaticONIVYDE/5-FU/LV, the incidence of Grade 3/4 neutropenia was adenocarcinoma of the pancreashigher among Asian (18/33 [55%]) vs White patients (13/73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of AsianIMPORTANT SAFETY INFORMATION vs 1% of White patientsWARNING: SEVERE NEUTROPENIA and SEVERE DIARRHEA Severe Diarrhea: See Boxed WARNING. Severe and life-Fatal neutropenic sepsis occurred in 0.8% of patients receivingthreatening late-onset (onset 24 hours after chemotherapy [9%]) ONIVYDE. Severe or life-threatening neutropenic fever or sepsisand early-onset diarrhea (onset 24 hours after chemotherapy [3%], occurred in 3% and severe or life-threatening neutropenia occurred insometimes with other symptoms of cholinergic reaction) were 20% of patients receiving ONIVYDE in combination with 5-FU and LV.observed3 Interstitial Lung Disease (ILD): Irinotecan HCl can cause severe Withhold ONIVYDE for absolute neutrophil count below 1500/mm orand fatal ILD. Withhold ONIVYDE in patients with new or neutropenic fever. Monitor blood cell counts periodically during treatment progressive dyspnea, cough, and fever, pending diagnostic evaluation.Severe diarrhea occurred in 13% of patients receiving ONIVYDE inDiscontinue ONIVYDE in patients with a confirmed diagnosis of ILDcombination with 5-FU/LV. Do not administer ONIVYDE to patientsSevere Hypersensitivity Reactions: Irinotecan HCl can cause with bowel obstruction. Withhold ONIVYDE for diarrhea of Gradesevere hypersensitivity reactions, including anaphylactic reactions. 24 severity. Administer loperamide for late diarrhea of any severity.Permanently discontinue ONIVYDE in patients who experience a Administer atropine,if not contraindicated, for early diarrhea of any severity severe hypersensitivity reactionPlease see additional Important Safety Information throughout and Brief Summary of Full Prescribing Information, including Boxed Warning, on adjacent pages."