Prescribing Information
ONIVYDE® (irinotecan liposome injection)

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Two older men affected by metastatic pancreatic cancer sitting outside together Two older men affected by metastatic pancreatic cancer sitting outside together

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DOWNLOADABLE RESOURCE
FOR PATIENTS & CAREGIVERS

PDF icon for download of the ONIVYDE Patient Brochure

Download the
Patient Brochure

With the ONIVYDE Patient Brochure, patients and caregivers can learn about treatment with ONIVYDE + 5-FU/LV, plus find helpful resources—such as a printable side effects log and questions to ask your doctor.

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.

Logo of the organization Pancreatic Cancer Action Network
Pancreatic Cancer Action Network® (PanCAN®)
(877) 272-6226 pancan.org

PanCAN provides free, in-depth, and personalized resources and information on pancreatic cancer.

Logo of the organization National Comprehensive Cancer Network
National Comprehensive Cancer Network® (NCCN®)
(215) 690-0300 nccn.org

The National Comprehensive Cancer Network® (NCCN®) is dedicated to improving the quality of cancer care, so patients can lead better lives. Treatment with liposomal irinotecan (ONIVYDE) + 5-FU/LV is recommended by the NCCN for certain people with metastatic pancreatic cancer.*

Logo of the organization Let’s Win! Pancreatic Cancer Initiative
Let’s Win! Pancreatic Cancer Initiative 

letswinpc.org

Let’s Win! Pancreatic Cancer is changing the narrative around pancreatic cancer. Instead of sharing dismal statistics, Let’s Win! breaks down the barriers between patients, doctors, and researchers through a dynamic website and robust social media program in both English and Spanish. With a mission based on information and outreach, Let’s Win! focuses on unmet needs in the pancreatic cancer world. Its message is simple: Everyone who is diagnosed with pancreatic cancer should have easy access to information about the best treatment options available.

HELPFUL COMMON TERMS

The following is a list of common terms relating to pancreatic cancer and your treatment with ONIVYDE + 5-FU/LV.

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 “5-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 anticancer 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.

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.

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 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.

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Indication and Important Safety Information about ONIVYDE® (irinotecan liposome injection)

What is ONIVYDE used for?

ONIVYDE is a prescription medicine used to treat pancreatic cancer which has spread to other parts of the body. ONIVYDE can be used in patients who have already received gemcitabine treatment for their pancreatic cancer. ONIVYDE is given in combination with 2 other medicines, fluorouracil (also known as 5-FU) and leucovorin (which is often abbreviated as LV), and is not given alone.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ONIVYDE?

ONIVYDE can cause problems that can sometimes become serious or life threatening and can lead to death. Serious side effects may include fever and infection associated with a low white blood 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.

Before receiving ONIVYDE, tell your healthcare provider if you: 

  • have had a severe 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 are able to 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 man, you should not father a child during your treatment with ONIVYDE. ONIVYDE can harm the unborn baby of your partner. You should use an effective method of birth control during and for at least 4 months after the last dose of ONIVYDE,
  • are breastfeeding or plan to breastfeed. Patients should not breastfeed during treatment with ONIVYDE and for 1 month after the last dose.

What are possible side effects of ONIVYDE?

ONIVYDE can cause serious side effects, including: 

  • Infections (particularly if your white blood cells are low). 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.
  • Diarrhea. Symptoms of severe diarrhea may include persistent diarrhea; discolored stools (black, green or bloody); or symptoms of dehydration such as lightheadedness, dizziness, or faintness. 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.
  • Allergic reaction (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?

  • 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.
  • The most frequent side effects resulting in discontinuation of ONIVYDE were diarrhea, vomiting, and infection caused by low white blood cells (neutropenic sepsis).
  • The most frequent side effects requiring dose reductions of ONIVYDE were 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 called thrombocytopenia (platelets are important for clotting to stop bleeding).

Tell your healthcare provider about all the medicines you take, including:

  • prescriptions
  • over-the-counter medicines
  • vitamins
  • herbal supplements
These are not all the possible side effects of ONIVYDE.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. To learn more, talk to your healthcare provider. You can ask your doctor or pharmacist for information about ONIVYDE that is written for health 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.

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ONIVYDE is a registered trademark of Ipsen Biopharm Ltd.
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©2023 Ipsen Biopharmaceuticals, Inc. All rights reserved. March 2023 ONV-US-002248 v4.0