THE SUPPORT TO FIGHT ON

Helpful resources and information for oncology nurses

We at Ipsen understand how important oncology nurses are to the treatment experience of patients with cancer. Your ongoing efforts to support your metastatic pancreatic cancer patients are invaluable to helping them navigate their physical and emotional journey throughout treatment.

Below you will find helpful resources and information to assist you as you support your patients who are receiving ONIVYDE. It’s also important to watch for adverse reactions.

 

Dosing and Administration1

Review clear dosing instructions for ONIVYDE and help ensure appropriate treatment administration for your patients.1

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Certain Side Effects Management1

Lean about potential side effects that you may encounter in patients taking ONIVYDE and how to address them.1

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Patient Support Services

Tap into vital services from IPSENCARES.com to help with coverage, access, and financial assistance for your ONIVYDE patients.

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Downloadable PDFs

ONIVYDE Dosing Guide

Download this convenient dosing guide as a quick reference for ONIVYDE dosing and administration.

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ONIVYDE Reimbursement Overview

Review this comprehensive guide on coverage, claims, and reimbursement for ONIVYDE.

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ONIVYDE Patient Brochure

Use this patient brochure to help answer questions your patients may have about ONIVYDE and to provide practical advice on topics such as nutrition and managing diarrhea.

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Side Effects Log

Distribute this side effects log to help patients track treatment side effects and discuss them with you.

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PRODUCT J-CODE: J9205
The J9205 code for Injection, irinotecan liposome, 1 mg is effective for use on claims with dates of service on or after January 1, 2017 in both the hospital outpatient and physician office setting.

WATCH FOR ADVERSE REACTIONS

It’s important to watch for any adverse reactions that may impact your patients’ treatment. For instance, severe diarrhea can be an adverse reaction of ONIVYDE + 5‑FU/LV. However, adverse reactions from ONIVYDE + 5-FU/LV can be actively monitored, and may be manageable with dose modifications.

 

To help identify adverse reactions, you can ask patients specific questions during physical assessments, such as:

  • When did the diarrhea start, early or late after treatment?
  • Describe the diarrhea’s frequency and consistency
  • Have there been any other symptoms, such as nausea or vomiting?

 

 

Caregivers can also help identify any adverse reactions your patient may be experiencing. Some questions to ask caregivers would be:

  • Has the patient had more frequent bowel movements?
  • Has the patient been feeling overly fatigued?
  • Has the patient had fever?

 

 

 

Remember, to help patients continue on active therapy, ONIVYDE has dose modification recommendations to help manage certain adverse reactions, including diarrhea.

See dose modifications for ONIVYDE

ADDITIONAL RESOURCES FOR YOUR PATIENTS

Having information is an important way for patients to cope with the emotional impact of cancer. The independent organizations listed below may provide vital information and valuable community support for your patients with metastatic pancreatic cancer.

 

PANCREATIC CANCER ACTION NETWORK (PanCAN®)

pancan.org

877-272-6226

PanCAN® provides free, personalized education and support services to patients with pancreatic cancer and their caregivers, via phone or email.

 

THE LUSTGARTEN FOUNDATION’S “LET’S WIN” PATIENT INITIATIVE

letswinpc.org

The Lustgarten Foundation supports medical research of pancreatic cancer. Its patient information initiative, Let’s Win, provides compelling patient videos, disease and clinical trial information, recent research news, advice on managing the disease, and other helpful patient resources.

IMPORTANT SAFETY INFORMATION & INDICATION

WARNING: SEVERE NEUTROPENIA and SEVERE DIARRHEA
  • Fatal neutropenic sepsis occurred in 0.8% of patients receiving ONIVYDE. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving ONIVYDE in combination with 5-FU and LV. Withhold ONIVYDE for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment
  • Severe diarrhea occurred in 13% of patients receiving ONIVYDE in combination with 5-FU/LV. Do not administer ONIVYDE to patients with bowel obstruction. Withhold ONIVYDE for diarrhea of Grade 2-4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION

ONIVYDE® (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

CONTRAINDICATION
  • ONIVYDE is contraindicated in patients who have experienced a severe hypersensitivity reaction to ONIVYDE or irinotecan HCl
WARNINGS AND PRECAUTIONS
  • Severe Neutropenia: See Boxed WARNING. In patients receiving ONIVYDE/5-FU/LV, the incidence of Grade 3/4 neutropenia was higher among Asian (18/33 [55%]) vs White patients (13/73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of Asian vs 1% of White patients
  • Severe Diarrhea: See Boxed WARNING. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed
  • Interstitial Lung Disease (ILD): Irinotecan HCl can cause severe and fatal ILD. Withhold ONIVYDE in patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue ONIVYDE in patients with a confirmed diagnosis of ILD
  • Severe Hypersensitivity Reactions: Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue ONIVYDE in patients who experience a severe hypersensitivity reaction
  • Embryo-Fetal Toxicity: ONIVYDE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during and for 1 month after ONIVYDE treatment
ADVERSE REACTIONS
  • The most common adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%)
  • The most common Grade 3/4 adverse reactions (≥10%) were diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%)
  • Adverse reactions led to permanent discontinuation of ONIVYDE in 11% of patients receiving ONIVYDE/5-FU/LV; The most frequent adverse reactions resulting in discontinuation of ONIVYDE were diarrhea, vomiting, and sepsis
  • Dose reductions of ONIVYDE for adverse reactions occurred in 33% of patients receiving ONIVYDE/5-FU/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia
  • ONIVYDE was withheld or delayed for adverse reactions in 62% of patients receiving ONIVYDE/5-FU/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia
  • The most common laboratory abnormalities (≥20%) were anemia (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%), hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia (35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia (29%), and hyponatremia (27%)
DRUG INTERACTIONS
  • Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies ≥2 weeks prior to initiation of ONIVYDE
  • Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to starting therapy
USE IN SPECIFIC POPULATIONS
  • Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise males with female partners of reproductive potential to use condoms during and for 4 months after ONIVYDE treatment
  • Lactation: Advise nursing women not to breastfeed during and for 1 month after ONIVYDE treatment
Please see full Prescribing Information, including Boxed WARNING.

 

References: 1. ONIVYDE [package insert]. Basking Ridge, NJ. Ipsen Biopharmaceuticals, Inc.; 2017. 2. Ipsen data on file: IQVIA medical claims post-gemcitabine usage analysis, June 2018-May 2019. 3. Ipsen data on file. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma V.1.2020. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed November 26, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. 5. Sohal DPS, Kennedy EB, Khorana A, et al. Metastatic Pancreatic Cancer ASCO Clinical Practice Guideline Update. J Clin Oncol. 2018;36(24):2545-2556. 6. Deeb A, Haque S-U, Olowokure O. Pulmonary metastases in pancreatic cancer, is there a survival influence? J Gastrointest Oncol. 2015;6(3):E48-E51. 7. Data on file #1. Basking Ridge, NJ. Ipsen Biopharmaceuticals, Inc.; 2015. 8. Wang-Gillam A, Li C-P, Bodoky G, et al. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016;387:545-557. 9. Zhang H. Onivyde for the therapy of multiple solid tumors. OncoTargets Ther. 2016;9:3001-3007. 10. Locker GY, Hamilton S, Harris J, et al. ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. J Clin Oncol. 2006;24(33):5313-5327. 11. Columbia University Irving Medical Center. The Pancreas Center. Lab tests. https://columbiasurgery.org/pancreas/lab-tests. Accessed January 29, 2020. 12. NIH. National Cancer Institute. Pancreatic cancer treatment (adult) (PDQ®)-health professional version. https://www.cancer.gov/types/pancreatic/hp/pancreatic-treatment-pdq. Accessed November 27, 2019. 13. Ducreux M, Cuhna AS, Caramella C, et al; on behalf of ESMO Guidelines Committee. Cancer of the pancreas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(suppl 5):v56-v68. 14. Wang-Gillam A, Huber RA, Siveke JT, et al. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors. Eur J Cancer. 2019;108:78-87. 15. Data on file #3. Basking Ridge, NJ. Ipsen Biopharmaceuticals, Inc.; 2015.

©2020 Ipsen Biopharmaceuticals, Inc. All rights reserved. February 2020 ONV-US-002301

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