Prescribing Information
ONIVYDE® (irinotecan liposome injection)

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  • SUPPORT & RESOURCES
  • IPSEN CARES®
A woman with metastatic pancreatic cancer with her dog A woman with metastatic pancreatic cancer with her dog

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SIGN UP FOR IPSEN CARES®

Helping patients get access to their prescribed medications with the information and support they need

IPSEN CARES® (Coverage, Access, Reimbursement & Education Support) serves as a central point-of-contact among patients/caregivers, healthcare providers, insurance companies, and Specialty Pharmacies.

Patient support for eligible and enrolled patients prescribed ONIVYDE

Once the provider has prescribed ONIVYDE, the IPSEN CARES®  Patient Access Specialists are fully dedicated to:

  • Facilitating patients’ access to their prescribed medications
  • Providing information and support for the interactions among offices, patients, and insurance companies for Ipsen medications 
Program enrollment is quick and easy for patients/caregivers

Patients must be enrolled to access all IPSEN CARES support offerings.

STEP 1: Patient and HCP access the IPSEN CARES Enrollment Form online and complete it at the office.

STEP 2: Once a completed Enrollment Form is received, an IPSEN CARES Patient Access Specialist will conduct a benefits verification to review the patient’s out-of-pocket costs associated with the Ipsen medication. Additional support offerings for which the patient may be eligible will be discussed at that time.

Patient authorization

Patients are required to sign the ONIVYDE Patient Authorization Form every 3 years, or sooner if required by state law, to give the Patient Access Specialists at IPSEN CARES permission to access the patient’s personal health information in order to help with treatment. The form can be signed and submitted online, or by downloadable PDF, which must be printed, filled out, signed, and faxed.

Help with copays?

Check for copay coverage. Considering that some patients need financial assistance, our copay assistance programs may help eligible* patients with the cost of their treatment.

The ONIVYDE Copay Assistance Program for eligible, commercially insured patients is available by enrolling in IPSEN CARES. Here is the key information:

  • Patients may pay as little as $0 per prescription
  • For patients utilizing the Medical Benefit, we will send details for claims processing on behalf of the patient directly to the doctor’s office
  • For patients who are eligible for government health benefits (eg, Medicare, Medicaid, TRICARE), IPSEN CARES may be able to offer the contact information for independent nonprofit foundations that may be able to offer financial assistance
Free medication

Uninsured patients may be eligible for free medication through our Patient Assistance Program. Patients may be eligible to receive free drug if they are experiencing financial hardship, are uninsured or functionally uninsured, are U.S. residents, and receive a valid prescription for an on-label indication for ONIVYDE as supported by information provided in the program application. Patients may enroll through IPSEN CARES. If eligible, they may receive free medication from Ipsen.

*See www.ipsencares.com for Copay Assistance Program Patient Eligibility & Terms and Conditions.

To learn more, call (866) 435-5677 from 8 AM to 8 PM ET, Monday to Friday, to speak with an IPSEN CARES representative; or visit www.ipsencares.com.

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IMPORTANT SAFETY INFORMATION AND INDICATION

WHAT’S THE MOST IMPORTANT INFORMATION I NEED TO 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 (neutropenic fever, neutropenic sepsis); diarrhea, lung problems (interstitial lung disease, a group of diseases which cause inflammation of the lung tissues leading to scarring); and reactions during administration of ONIVYDE (including anaphylactic reactions). 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 count change seen in ONIVYDE-treated pancreatic cancer patients, is a reduction in the number of white blood cells, specifically lower lymphocytes and neutrophils which are important for fighting infections.

Before you receive ONIVYDE, your healthcare provider will give you medications to decrease the potential for allergic reactions to infusion of ONIVYDE. You will also receive anti-nausea medicine to decrease nausea and vomiting, and, possibly, a medicine to decrease immediate diarrhea, called an anti-cholinergic.

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.

WHEN SHOULD ONIVYDE NOT BE GIVEN?

You should not receive ONIVYDE if:

  • you have had a severe allergic reaction to ONIVYDE or irinotecan HCl,
  • your white blood cell count is low (neutrophil white blood cell count below the level of 1,500 cells/mm3),
  • you have a fever and your neutrophil white blood cell count is low (also called neutropenic fever), or
  • you have a problem in your bowel that prevents food, fluids or gas from moving through your intestines.

Serious side effects may occur while taking ONIVYDE. Call or see your healthcare provider right away if you develop any of the following or if these get worse.

SERIOUS SIDE EFFECTS MAY INCLUDE:
  • 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.

Getting medical treatment right away may keep these problems from becoming more serious. 

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.

  • 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
PREGNANCY AND NURSING

If you are a female, tell your healthcare provider if you are pregnant or plan to become pregnant. ONIVYDE can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 1 month after the last dose of ONIVYDE. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant during treatment with ONIVYDE. Before receiving ONIVYDE, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if ONIVYDE passes into your breast milk. Do not breastfeed during treatment with ONIVYDE and for at least 1 month after the last dose of ONIVYDE.

If you 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.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNING.