Prescribing Information
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  • SUPPORT & RESOURCES
  • IPSEN CARES®

HELPING PATIENTS GET ACCESS

TO THEIR PRESCRIBED MEDICATIONS WITH THE INFORMATION AND SUPPORT THEY NEED

 

 

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TO BEGIN THE ENROLLMENT
PROCESS, VISIT OUR WEBSITE:

www.ipsencares.com/onivyde-patient-support

IPSEN CARES provides a single point of contact between patients/caregivers, healthcare providers, insurance companies, and Specialty Pharmacies

PHONE:

1-866-435-5677

FAX:

1-888-525-2416

HOURS: 8:00AM - 8:00PM ET
MONDAY - FRIDAY

NATIONWIDE ~100% OF INSURED LIVES HAVE COVERAGE FOR ONIVYDE15

The IPSEN CARES Program is staffed by dedicated Patient Access Specialists who can assist in a variety of ways:

Reimbursement assistance
  • Benefits Verification: verifies patients’ coverage, restrictions (if applicable), and copayment/coinsurance amounts
  • Prior Authorization (PA)/Appeals:
    • Provides information on documentation required by payers on PA specifics, and recommendations for next steps based on payer policy
    • Provides information on the payer-specific processes required to submit a level I or a level II appeal, as well as provides guidance as needed through the process
Financial support
  • Copayment Assistance: offers copayment assistance to eligible* patients. This includes referring to the ONIVYDE® (irinotecan liposome injection) Commercial Copay Program or referring to an independent nonprofit organization if available
  • Patient Assistance Program (PAP): determines patients’ eligibility† for PAP and dispenses free product to eligible patients
Product distribution
  • Institutions: ONIVYDE can be acquired from wholesaler
  • Private Practices:
    • Direct (buy-and-bill) acquisition from a group of approved specialty distributors
    • Specialty Pharmacy delivery (IPSEN CARES can provide helpful information on selection of the appropriate Specialty Pharmacy for the patient by calling 1-866-435-5677)
Patient support
  • Communication: conducts calls to both healthcare provider and patient with status updates about patient’s IPSEN CARES enrollment, benefits verification results, coverage status, dispense date, etc.
HCP online portal
  • The HCP Portal allows you to track the status of your patients enrolled in IPSEN CARES. We hope the HCP portal will be a convenient resource for you and your office. After you register and create a profile, your profile will be validated within 24 to 48 hours.
  • Through the online portal you can:
  • Send a message to the IPSEN CARES team
  • Upload relevant patient documents
  • Obtain Specialty Pharmacy dispensing information (if applicable)
  • Review case status notes for enrolled patients

Visit www.ipsencares.com/hcp-resources to learn more. 

*See Copay Assistance Program Patient Eligibility & Terms and Conditions.

†Patients may be eligible to receive free drug if they are experiencing financial hardship, are uninsured or functionally uninsured, are U.S. residents, received a prescription for an on-label use of ONIVYDE as supported by information provided in the program application, and meet income criteria based on an Experian soft credit check. Eligibility does not guarantee approval for participation in the program. The PAP provides ONIVYDE product only, and does not cover the cost of previously purchased product or medical services.

RESOURCES
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Contact an Ipsen Rep

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION AND 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

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.

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
CONTRAINDICATION
  • ONIVYDE is contraindicated in patients who have experienced a severe hypersensitivity reaction or anaphylaxis 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 including ONIVYDE 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 7 months after the last dose of 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%)
  • The following adverse reactions have been identified during post approval use of ONIVYDE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Immune system disorders: Hypersensitivity (including Anaphylactic reaction and Angioedema)
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 the last dose of ONIVYDE treatment
  • Lactation: Advise nursing women not to breastfeed during and for 1 month after the last dose of ONIVYDE treatment
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed WARNING.

 

References: 1. ONIVYDE® [package insert]. Ipsen Biopharmaceuticals, Inc. Cambridge, MA 02142; 2023. 2. Ipsen data on file: IQVIA medical claims post-gemcitabine usage analysis, June 2018 – October 2021. 3. Zhang H. Onivyde for the therapy of multiple solid tumors. Onco Targets Ther. 2016;9:3001-3007. 4. Dimou A, Syrigos KN, Saif MW. Overcoming the stromal barrier: technologies to optimize drug delivery in pancreatic cancer. Ther Adv Med Oncol. 2012;4(5):271-279. 5. Drummond DC, Noble CO, Guo Z, Hong K, Park JW, Kirpotin DB. Development of a highly active nanoliposomal irinotecan using a novel intraliposomal stabilization strategy. Cancer Res. 2006;66(6):3271-3277. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma V.1.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 5, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. 7. Oberstein PE, Olive KP. Pancreatic cancer: why is it so hard to treat? Ther Adv Gastroenterol. 2013;6(4):321-337. 8. Sercombe L, Veerati T, Moheimani F, Wu SY, Sood AK, Hua S. Advances and challenges of liposome assisted drug delivery. Front Pharmacol. 2015;6:286. 9. Hsueh C-T, Selim JH, Tsai JY, Hsueh C-T. Nanovectors for anti-cancer drug delivery in the treatment of advanced pancreatic adenocarcinoma. World J Gastroenterol. 2016;22(31):7080-7090. 10. Data on file #3. Basking Ridge, NJ. Ipsen Biopharmaceuticals, Inc.; 2015. 11. Wang-Gillam A, Hubner 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. 12. 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(10018):545-557. 13. Data on file #1. Basking Ridge, NJ. Ipsen Biopharmaceuticals, Inc.; 2015. 14. Department of Health and Human Services. U.S. Food and Drug Administration. ONIVYDE (irinotecan liposome injection) Approval Letter. NDA 207793. October 22, 2015. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207793Orig1s000Approv.pdf. Accessed March 28, 2022. 15. Ipsen data on file: Breakaway Partners dashboard.

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