Understanding
Therapy with
ONIVYDE®
(irinotecan
liposome
injection)

PATIENT BROCHURE

This guide provides tips on how to be proactive as you work with your medical team during therapy.

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PROVYDE GUIDE TO PATIENT SUPPORT SERVICES

To learn about our patient financial assistance programs and how PROVYDE can help you access ONIVYDE, click below to download the guide.

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About ONIVYDE

ONIVYDE® (irinotecan liposome injection)

What is ONIVYDE® (irinotecan liposome injection)?

ONIVYDE contains a chemotherapy drug called irinotecan, which in its active form interrupts cell reproduction. Irinotecan can be built into a container called a liposome. These liposomes are designed to release the medicine slowly over time.

In the clinical trial that led to FDA approval, ONIVYDE was studied in combination with 2 other drugs called fluorouracil and leucovorin. This combination is referred to as ONIVYDE + 5-FU/LV.

How ONIVYDE was studied

Your doctor may recommend ONIVYDE to treat your metastatic pancreatic cancer. The effectiveness of ONIVYDE + 5-FU/LV was demonstrated in a clinical trial. Patients were split into 3 groups receiving ONIVYDE + 5-FU/LV, 5-FU/LV alone, or ONIVYDE alone.

ONIVYDE® (irinotecan liposome injection)

In this trial, ONIVYDE + 5-FU/LV demonstrated an improvement in median overall survival (OS). An improvement in median OS means patients receiving ONIVYDE + 5-FU/LV had a greater chance of living longer when compared with the 5-FU/LV alone group (6.1 months [4.8–8.5] median OS vs 4.2 months [3.3–5.3]).

ONIVYDE may not work for every patient. Individual results may vary.

The OS data from this study supported the approval of ONIVYDE + 5-FU/LV for use in patients with metastatic pancreatic cancer whose disease has progressed following treatment with gemcitabine or gemcitabine in combination with another therapy. ONIVYDE is not approved for use as a single drug without 5-FU/LV.

For more information about therapy with ONIVYDE, download the patient brochure.

Selected Safety Information

The most common side effects which were seen in people with pancreatic cancer treated with ONIVYDE include: diarrhea, feeling tired, vomiting, nausea, loss of appetite, inflammation in the mouth, fever, and dehydration. When taking ONIVYDE, you may also have abnormal blood test results. The most common blood cell count change seen in ONIVYDE-treated pancreatic cancer patients is a reduction in the number of white blood cells, specifically lower lymphocytes and neutrophils (types of white blood cells), which are important for fighting infections.

The most common serious side effects of ONIVYDE were diarrhea, vomiting, fever and infection associated with low white blood cell count (also known as neutropenic fever or neutropenic sepsis), nausea, fever, sepsis (a complication of an infection), dehydration, septic shock (a severe complication of infection in which blood pressure drops dramatically), pneumonia, acute renal failure, and thrombocytopenia (also known as a low platelet count).

Patient Support Services

ADDITIONAL RESOURCES FOR
YOU AND YOUR CAREGIVER

Below is a list of support groups, organizations, and major cancer research hospitals that may be helpful for you and your caregiver while you are on therapy.

American Association for Cancer Research
The American Association for Cancer Research has a mission to prevent and cure cancer through communication, collaboration, education, and especially research. They are also involved in advocacy and government affairs.
www.aacr.org

American Cancer Society (ACS)
ACS is a nationwide, community-based voluntary health organization that has been working to improve the lives of cancer patients for over 100 years. The organization offers a wide range of support resources, as well as educational materials and opportunities for involvement in the fight against cancer.
www.cancer.org

American Society of Clinical Oncology (ASCO)
ASCO encourages and provides opportunities for lifelong learning for oncology professionals. The goal of the organization is to use research and education to make a difference in the lives of people with cancer, while partnering with a worldwide network of expert oncologists.
www.asco.org

CancerCare
CancerCare provides a range of resources for cancer patients, including counseling services (telephone, online, and/or in person), support groups for both patients and caregivers, education, publications, as well as financial and co-payment assistance. 
www.cancercare.org

Cancer Support Community (CSC) 
CSC offers social and emotional support for people impacted by cancer, including patients, families, and caregivers, including a support community over the phone and online. The organization is also involved in patient advocacy through the Cancer Policy Institute.
www.cancersupportcommunity.org

Hirshberg Foundation for Pancreatic Cancer Research
This national, nonprofit organization is committed to advancing pancreatic cancer research, while providing support to patients and their families. 
www.pancreatic.org

Let'sWinPC
Let’s Win is an unprecedented platform that enables doctors, scientists, and patients to share fast-breaking information on potentially life-saving pancreatic cancer treatments and clinical trials that go beyond the standard of care. 
www.letswinpc.org

Lustgarten Foundation 
The Lustgarten Foundation is dedicated to improving the lives of patients with pancreatic cancer by increasing the funding and support of research, fostering the dialogue in the medical and scientific community, and increasing public awareness of the disease and providing support for patients and their loved ones.
www.lustgarten.org

National Cancer Institute (NCI)
NCI is the federal government's principal agency for cancer research and training. The institute coordinates the National Cancer Program, which is involved in research and other programs that support cancer patients and their families.
www.cancer.gov

National Coalition for Cancer Survivorship 
Founded by and for cancer survivors, this organization offers resources for patient support and advocacy for improving the lives of cancer patients and their families.
www.canceradvocacy.org

National Comprehensive Cancer Network® (NCCN®)
This organization is a not-for-profit alliance of 26 of the world's leading cancer centers. The NCCN is dedicated to improving the quality, effectiveness, and efficiency of cancer care through patient care, research, and education.
www.nccn.org

Pancreatic Cancer Action Network
PanCAN connects people who are committed to working together to advance research, support patients, and create hope for those affected by pancreatic cancer. This nationwide organization offers resources for those affected by pancreatic cancer, as well as opportunities to get involved in the national fight against pancreatic cancer. 
www.pancan.org

Pancreatica 
Pancreatica.org is designed to serve as an online hub for the latest news and information in regard to clinical trials and other options in the treatment of pancreatic cancer. The website provides information about diagnosis and treatment, as well as opportunities to connect with other members of the pancreatic cancer community, both online and in your local community.
www.pancreatica.org

Patient Advocate Foundation
The Patient Advocate Foundation offers professional case management services to Americans with chronic, life threatening, and debilitating illnesses, as well as information about healthcare reform. The organization’s goal is to empower patients and provides many resources for patients and their families and caregivers. 
www.patientadvocate.org

Stand Up To Cancer 
Stand Up To Cancer encourages collaboration among expert researchers in the cancer community. The organization also leverages the entertainment industry to increase awareness among the general public.
www.standup2cancer.org

The National Pancreas Foundation
The National Pancreas Foundation is involved in research and advocacy efforts, while providing support and education for patients, caregivers, and healthcare professionals in the pancreatic cancer community.
www.pancreasfoundation.org

Important Safety Information about ONIVYDE®
(irinotecan liposome injection)

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Important Safety Information about ONIVYDE®
(irinotecan liposome injection)