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This is the real-life account of one individual’s experience living with metastatic pancreatic adenocarcinoma and using ONIVYDE® (irinotecan liposome injection). This is not representative of all experiences. The information provided is not intended to be a substitute for professional medical advice, diagnosis, or treatment.
This is the real-life experience of one individual’s experience living with metastatic pancreatic adenocarcinoma and using ONIVYDE® (irinotecan liposome injection) as a first treatment option. This is not representative of all experiences. The information provided is not intended to be a substitute for professional medical advice, diagnosis, or treatment. If you or a loved one is diagnosed with metastatic adenocarcinoma, it is recommended to talk to your doctor about the treatment options that may be right for you.
Please see Indication and Important Safety Information at the end of the video and full Prescribing Information, including Important Warnings at onivyde.com.
This video is sponsored by Ipsen Biopharmaceuticals, Inc. and Mike has been compensated for his time.
My name is Mike and I live in the Shelton, Washington area.
Basically, I retired at the age of 64 and a half. Sherri is my wife of 30 years. We just had an anniversary. We're very active, enjoying the outdoors and having a great time working on remodeling our house and getting away from the city. And it's very, very peaceful out here.
I was noticing my urine color. It was very dark, but I didn't think much of it. I thought it might have been a urinary tract infection. And then one night Sherri and I went out to dinner, and she's sitting across the table looking at me and she goes, "Your eyes are yellow." I went home, read about it and kind of understood the severity of what is jaundice. Got an appointment at the local clinic here, so I ended up having a CAT scan. And then after that it was determined to be some sort of cancerous growth in my pancreas. It was determined that it had spread to my liver. And that's kind of where it started.
At first I took it pretty poorly. I mean, I was basically devastated. I chose to be like "Am I going to think that this is going to beat me?" Or, "Am I going to try to turn this around and be positive?” And that kind of really never left me after that point. When he was first diagnosed with cancer, it was very devastating. The diagnosis itself was—it was shocking, we are shocked. What do we do now? What's our next step? We were fortunate that we got hooked up with a good care team and doctors, and we just went. We just did it. We had a great doctor who even allowed us to send him texts if we had questions on things.
Then I was referred to an oncologist knowing that I would move forward with the chemo sessions. And he was all excited about the development of a drug that he thought would help me. That in itself was motivating for me to move forward. And I had confidence and faith in what was presented to me and thought it would be a good direction to go. My community oncologist recommended a NALIRIFOX regimen, which includes ONIVYDE. My oncologist explained that this is an FDA-approved option.
His excitement with what would possibly be the future for me in moving forward was having this treatment. And then after that, it would be determined on what would be next.
ONIVYDE® (irinotecan liposome injection) is indicated, in combination with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma.
ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.
Limitations of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma.
My care team explained further what this treatment plan would look like, and that it is the most recent FDA-approved first-line treatment for metastatic pancreatic cancer. My oncologist and the nurses gave me the background on my side effects that may happen with a packet of information. One thing that's important to everyone that has pancreatic cancer is to learn to be your own advocate. Contact your care team if you have any questions. Look at all the available information that you can get. I actually went in and researched everything on my own to understand what the side effects of everything in that package would do to my body.
My doctor told me that ONIVYDE can cause serious side effects and can be severe and life-threatening and can lead to death, including fever and infection associated with low white blood cell count and severe diarrhea. I personally experienced fatigue and neuropathy and revised my routine to help manage these side effects. In addition, I experienced impacts on my taste buds and diet on the days that I had treatment.
Part of managing Mike's side effects included consulting with his HCP for dose adjustments.
The balance that I had to find was when I had the energy. I would always go if I was capable. And even to the point when I didn't have that energy, I still tried. Keeping busy was real important. Having things to do was real important. But also in my own sort of weird way was my faith. My mom passed away. I still make a habit of going down to the lake and talking to her at least once a week. So it really helps me.
The IPSEN CARES® nurse called every other week after my chemo. She did answer a lot of questions but for me the most important part was it gave me that person that I could talk to about what I was going through.
IPSEN CARES can even help explore options for financial support and they have an assistance program to help with ONIVYDE co-pays if you have commercial insurance. They also have support for people with government insurance or no insurance.
The hospital actually sent in a dietitian and talked to me about the things that I should eat. Basically, it was a lot of healthy greens, vegetables. It was important to keep my weight up. And even to this day, because I did drop a lot of weight, I'm trying to gain it all back.
I was treated for 10 months and no longer am receiving treatment. While I am no longer being treated, I work with my care team closely to monitor how things are going and I'm thankful to be able to share my story.
We support each other, we work good as a team. In the beginning, I did ask a lot of questions like what do I need to be prepared for? What do I need to have? And so they would tell me for side effects you may need this or that. And so I stocked up on pretty much everything they suggested.
I did the shopping, the cooking, cleaning, and pay all the bills and keep up with the medical stuff. I did a lot of these things so he could reserve his energy, so we could spend more time together and he could heal and get better.
The hopeful stories were very important to us, to help us maintain our positivity, keep us strong. What I did for myself was I would just make sure that I got enough rest so I could recharge, and keep going. I had family and friends always there for us and it really helped a lot.
It made you appreciate the small things and like going out to dinner with your wife or just talking with your wife. I really think that the best thing that people need to hear is that this gives them hope. You kind of have to pack away the stresses of disease or maybe any sort of health issue and really look at the good things. That's my sincere hope for everybody. That’s what I've done and that's what I will continue to do.
WHAT IS ONIVYDE?
ONIVYDE® (irinotecan liposome injection) is a prescription medicine used to treat adults with pancreatic cancer that has spread to other parts of the body:
- As a first treatment option, ONIVYDE is given in combination with 3 other medicines, oxaliplatin, fluorouracil (also known as FU), and leucovorin (which is often abbreviated as LV).
- ONIVYDE in combination with FU and LV can be used in patients who have already received gemcitabine treatment for their pancreatic cancer.
- ONIVYDE is not given alone.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ONIVYDE?
ONIVYDE can cause serious side effects that can be severe and life threatening and can lead to death, including fever and infection associated with a low white blood cell count (severe neutropenic fever or neutropenic sepsis) and severe diarrhea.
Call your doctor or get medical help right away if you experience these problems after treatment with ONIVYDE.
Who should not take ONIVYDE?
Do not take ONIVYDE if you have had a severe allergic reaction to ONIVYDE or irinotecan HCl.
What should I tell my healthcare provider before taking ONIVYDE?
Before taking ONIVYDE, tell your healthcare provider if you:
- have had an allergic reaction to ONIVYDE or irinotecan HCl.
- have a problem in your bowel that prevents food, fluids, or gas from moving through your intestines.
- are pregnant or planning to become pregnant. Females who can potentially become pregnant should use effective birth control (contraception) during treatment with ONIVYDE and for 7 months following the last dose of ONIVYDE due to potential risk to the fetus.
- are a male with a female partner of reproductive potential. Males should use condoms during treatment with ONIVYDE and for at least 4 months after the last dose. ONIVYDE may harm the unborn baby of your partner.
- are breastfeeding or plan to breastfeed. Patients should not breastfeed during treatment with ONIVYDE and for 1 month after the last dose.
- have pre-existing lung disease, have used medications that are known to cause toxicity to your lungs, medicines called colony-stimulating factors, or have previously received radiation therapy.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with ONIVYDE. Keep a list of all your medicines and show it to your healthcare provider and pharmacist and ask if it is safe to take ONIVYDE with all of your other medicines.
What are possible side effects of ONIVYDE?
ONIVYDE can cause serious side effects, including:
- Very low white blood cell counts. ONIVYDE can cause severe or life-threatening low white blood cell counts and fatal infections due to low white blood cell counts. Symptoms of infection may include fever, chills, dizziness, or shortness of breath. Blood cell counts will be monitored periodically by your healthcare provider during treatment. Contact your healthcare provider immediately if you are experiencing signs of infection, such as fever, chills, dizziness, or shortness of breath.
- Severe Diarrhea. Symptoms may include persistent vomiting or diarrhea; discolored stools (black, green or bloody); or symptoms of dehydration such as lightheadedness, dizziness, or faintness. Contact your healthcare provider if you experience any of these symptoms. Tell your healthcare provider if you experience persistent vomiting or diarrhea. Your healthcare provider may treat diarrhea with anti-diarrhea medicines (loperamide or atropine).
- Lung problems (interstitial lung disease). Symptoms of interstitial lung disease include new onset of cough or difficulty breathing and fever. Tell your healthcare provider right away if you get these symptoms.
- Allergic reactions (hypersensitivity). Seek immediate medical attention for signs of severe reaction such as chest tightness; shortness of breath; wheezing; dizziness or faintness; or swelling of the face, eyelids, or lips when receiving or during the 24 hours after receiving ONIVYDE.
Your healthcare provider will check you for these problems during treatment with ONIVYDE. Your healthcare provider may also need to delay or completely stop treatment with ONIVYDE, if you have severe side effects.
What are the most common side effects of ONIVYDE in combination with oxaliplatin, fluorouracil, and leucovorin?
- The most common side effects that were seen in people with pancreatic cancer treated with ONIVYDE include: diarrhea, feeling tired (fatigue), nausea, vomiting, decreased appetite, pain around the stomach, the mucous membranes that line your mouth and gastrointestinal tract becoming inflamed (mucosal inflammation), constipation, and weight loss.
- The most frequent side effects resulting in permanent discontinuation of ONIVYDE were low white blood cells (neutropenia), low platelet counts (thrombocytopenia) (platelets are important for clotting to stop bleeding), diarrhea, feeling tired, infections, and stroke (cerebrovascular accident (CVA), an interruption in the flow of blood to the cells in the brain).
- The most frequent side effects requiring dose reductions of ONIVYDE were low red blood cell count (anemia), decreased appetite, diarrhea, feeling tired, low white blood cell count with a fever (febrile neutropenia), low potassium (hypokalemia), abnormal liver tests, nausea, the mucous membranes that line your mouth and gastrointestinal tract becoming inflamed, low white blood cell count, peripheral neuropathy (condition that results when nerves that carry messages to and from the brain and spinal cord and to the rest of the body are damaged or diseased), vomiting, low platelet counts, and weight loss.
- The most frequent side effects requiring dose interruptions of ONIVYDE were hypersensitivity (the body reacts with an exaggerated immune response to a foreign substance) and infusion-related reaction (any signs or symptoms experienced by the patient during the infusion).
What are the most common side effects of ONIVYDE in combination with fluorouracil and leucovorin?
- The most common side effects that were seen in people with pancreatic cancer treated with ONIVYDE include: diarrhea, feeling tired, vomiting, nausea, decreased appetite, inflammation in the mouth, fever, and dehydration.
- The most frequent side effects resulting in permanent discontinuation of ONIVYDE were diarrhea, vomiting, and sepsis.
- The most frequent side effects requiring dose reductions of ONIVYDE were low white blood cells (neutropenia), diarrhea, nausea, and low red blood cell count (anemia).
- The most frequent side effects requiring dose interruptions or delays of ONIVYDE were neutropenia, diarrhea, fatigue, vomiting, and low platelet counts (thrombocytopenia) (platelets are important for clotting to stop bleeding).
These are not all the possible side effects of ONIVYDE. Tell your healthcare provider if you have any side effects that bother you or that do not go away. To learn more, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about ONIVYDE that is written for healthcare professionals, and it can be found at ONIVYDE.com.
If you think you or someone you know has experienced an adverse event related to an Ipsen product or has a product complaint, please contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127. You are encouraged to report side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including IMPORTANT WARNINGS at ONIVYDE.com.
Downloadable resources
for patients & care partners
Download the
Patient Brochure
Download the
Patient Brochure
With the ONIVYDE patient brochure, patients and caregivers can learn about ONIVYDE treatment, including how it works, possible side effects, and additional helpful information.
Download the
Care Team Discussion Guide
Download the
Care Team Discussion Guide
You and your family or friends may have many questions as you start treatment with a regimen that contains ONIVYDE. Use this guide to start conversations with your care team to help you on your treatment journey.
Download Brochure
About What to Expect with Treatment
Download Brochure
About What to Expect with Treatment
Managing your treatment journey may seem complicated and, sometimes, overwhelming. This brochure can help you feel in control of your treatment journey by providing information and resources that you may find helpful along the way.
SUPPORT RESOURCES FOR PANCREATIC CANCER
Coping with the physical and emotional impacts of cancer can be difficult. The following is a list of helpful organizations for people with pancreatic cancer and their caregivers.
Pancreatic Cancer Action Network® (PanCAN®)
Pancreatic Cancer Action
Network® (PanCAN®)
(877) 272-6226 pancan.org
PanCAN® provides free, in-depth, and personalized resources and information on pancreatic cancer.
National Comprehensive Cancer Network® (NCCN®)
National Comprehensive Cancer
Network® (NCCN®)
(215) 690-0300 nccn.org
NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives.*
NCCN=National Comprehensive Cancer Network® (NCCN®).
Let’s Win! Pancreatic Cancer Initiative
Let’s Win! Pancreatic
Cancer Initiative
Let’s Win is the go-to resource for the pancreatic cancer community, providing vital information and much-needed hope and inspiration to patients and caregivers.
The information above is provided for your information, and is not an endorsement of these organizations, nor an implication that these organizations endorse Ipsen or its products or services.
GLOSSARY OF COMMON TERMS
The following is a list of common terms relating to pancreatic cancer and your treatment.
Chemotherapy (kee-moh-THEH-ra-pee)
Medicines or drugs used to treat cancer. Commonly referred to as “chemo.”
Fluorouracil (floor-oh-YOOR-a-sil)
A chemotherapy drug used to treat certain types of cancer. Also known as “FU.”
Gemcitabine (gem-SITE-a-bean)
A chemotherapy drug used to treat certain types of cancer.
Intravenous (in-truh-VEE-nuss) infusion
A method of delivering fluids and medicine using a needle or thin tube (called a catheter) inserted into a vein. Often referred to as “IV.”
Irinotecan (ear-ee-no-TEE-can)
A chemotherapy drug used to treat certain types of cancer.
Leucovorin (loo-koh-VOOR-in)
A drug (also called “folinic acid,” and derived from folic acid) used to treat certain types of cancer, as well as certain types of anemia. Also known as “LV.”
Liposome (LIPE-oh-sohm)
A formulation that helps to deliver microscopic substances (such as anti-cancer drugs) to cells in the body.
Lymphocytes (LIM-foh-sites)
Cells that originate from stem cells, making up about 20-30 percent of the white blood cells found in normal human blood.
Metastatic (meh-tuh-STA-tik)
Cancer that has spread from where it first started (the primary site) to other organs or structures in the body.
NALIRIFOX (nuh-LEE-ree-fox)
A treatment regimen given as a first treatment for metastatic pancreatic cancer.
Neutropenia (noo-troh-PEE-nee-uh)
A decrease in the number of white blood cells (neutrophils) that respond quickly to an infection. Having neutropenia increases a person’s risk of getting an infection.
Neutrophils (NOO-troh-fills)
White blood cells that respond quickly to an infection.
ONIVYDE (ah-NEE-vied)
The product name for liposomal encapsulated irinotecan, a chemotherapy drug used to treat metastatic pancreatic cancer.
Oxaliplatin (aak-sa-lee-PLAT-tin)
An anti-cancer drug containing platinum that can stop or slow the growth of cancer cells and may cause them to die.
White blood cell count
The number of white blood cells in a blood sample, determined through a laboratory blood test.
*Referenced with permission from the National Comprehensive Cancer Network, Inc. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed December 15, 2023. To view the most recent and complete version of the recommendations, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
