What is Onivyde?
Onivyde (irinotecan liposomal) is a chemotherapy medication that is given by injection and may be used to treat pancreatic cancer that has spread (metastatic pancreatic adenocarcinoma). It is approved for use in combination with:
- Oxaliplatin, fluorouracil, and leucovorin (the NALIRIFOX regimen) as a first-line treatment for adults with metastatic pancreatic adenocarcinoma
- Fluorouracil and leucovorin, for adults with metastatic pancreatic adenocarcinoma with disease progression following the use of gemcitabine-based therapy.
Onivyde contains encapsulated irinotecan which allows it to remain in circulation for longer than unencapsulated irinotecan before it is converted to its active metabolite SN-38. Research has shown it demonstrates higher and more sustained levels of irinotecan and SN-38 compared with free irinotecan. A study, NAPOLI 3, demonstrated superiority in overall survival, a 1.9-month benefit, with the NALIRIFOX regimen with regards to nab-paclitaxel plus gemcitabine. NALIRIFOX has not been compared directly to modified FOLFIRINOX (a standard regimen that combines the same drugs oxaliplatin, fluorouracil, and leucovorin with unencapsulated irinotecan).
Irinotecan and its active metabolite SN-38 work by binding to topoisomerase 1. This is an enzyme that relieves tension in DNA by inducing single-strand breaks. When irinotecan binds to topoisomerase 1-DNA complex, it prevents the single strand of DNA from joining back together which leads to time-dependent double-strand DNA damage and cell death.
Onivyde was FDA-approved on October 22, 2015.
Products containing irinotecan including Onivyde can cause severe, life-threatening allergic reactions, including anaphylaxis.
May cause life-threatening or fatal interstitial lung disease (ILD). The risk is higher in patients with pre-existing lung disease, in those taking colony-stimulating factors or medications with lung toxicity as a side effect, or in those who have previously received radiation therapy. Your healthcare provider will monitor you for respiratory symptoms. Tell your doctor if you experience any new or worsening shortness of breath, cough, or fever.
May cause severe or life-threatening neutropenia (low levels of neutrophils), fatal neutropenic sepsis, or diarrhea. Diarrhea may occur more than 24 hours following chemotherapy administration (late onset) or within 24 hours (early onset). To reduce the risk, patients should stop lactose-containing products, eat a low-fat diet, and maintain hydration during treatment. Do not administer Onivyde to people with a bowel obstruction.
Onivyde can cause harm to an unborn baby when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment with Onivyde and for seven months after the last dose.
Not for use as a single agent for metastatic pancreatic adenocarcinoma.
Related/similar drugsfluorouracil, capecitabine, Xeloda, gemcitabine, Lynparza, Afinitor
You should not use this medicine if you are allergic to Onivyde, irinotecan, or any of the inactive ingredients in the injection.
Tell your doctor if you:
- Have liver or kidney disease
- Have lung disease or
- Have an intestinal disorder or obstruction
- Are pregnant or intend to become pregnant
- Are breastfeeding.
Onivyde can harm an unborn baby if the mother or the father is using this medicine.
If you are a woman, you may need to have a negative pregnancy test before starting treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 7 months after your last dose. Tell your doctor right away if you inadvertently become pregnant.
If you are a man, use condoms if your sex partner can get pregnant. Keep using condoms for at least 4 months after your last dose. Tell your doctor right away if a pregnancy occurs.
Do not breastfeed while using this medicine, and for at least 1 month after your last dose.
How is Onivyde administered?
Onivyde is given as a slow infusion into a vein. A healthcare provider will give you this injection and provide premedication with a corticosteroid and an antiemetic 30 minutes before the infusion.
- Onivyde must be given slowly, and the infusion can take up to 90 minutes to complete.
- Onivyde can cause severe diarrhea, which can be life-threatening if it leads to dehydration.
- Your doctor may recommend keeping anti-diarrhea medicine on hand at all times (such as loperamide or Imodium). Take this medicine at the first sign of loose or frequent bowel movements. Do not take loperamide for longer than 2 full days without your doctor's advice.
- Call your doctor whenever you have diarrhea during your treatment with Onivyde.
You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Onivyde.
What should I avoid while receiving Onivyde?
Avoid driving or hazardous activity until you know how Onivyde will affect you. Your reactions could be impaired.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
To reduce the risk of diarrhea, stop lactose-containing products, eat a low-fat diet, and maintain hydration during treatment.
What are the side effects of Onivyde?
Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.
Onivyde can cause severe diarrhea, which can be life-threatening. Call your doctor whenever you have diarrhea during your treatment with Onivyde.
Onivyde may cause other serious side effects. Call your doctor at once if you have:
- severe or ongoing vomiting
- black or bloody stools
- sores or white patches in or around your mouth
- new or worsening cough or shortness of breath
- dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin
- low blood cell counts--fever, tiredness, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or
- symptoms of sepsis--confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill.
Common side effects of Onivyde occurring in 20% or more patients may include:
- fever or other signs of infection
- mouth sores
- nausea or vomiting
- loss of appetite
- abdominal pain
- weight loss
- laboratory changes
- feeling weak or tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What other drugs will affect Onivyde?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make Onivyde less effective.
- Avoid the use of strong CYP3A4 inducers if possible. Substitute non-enzyme inducing therapies at least 2 weeks before initiation
- Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible; discontinue strong CYP3A4 inhibitors at least 1 week before starting therapy.
Many drugs can affect Onivyde. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Storage and handling
Store at 2°C to 8°C (36°F to 46°F). Do NOT freeze. Protect from light.
Onivyde is a cytotoxic drug and all applicable special handling and disposal procedures should be followed
Active: irinotecan hydrochloride
Inactive: 1,2-distaroyl-SN-glycero-3-phosphocholine, cholesterol, sodium N-(carbonyl-methoxy polyethylene glycol 2000)-1,2-distearoyl-SN-glycero-3-phosphoethanolamine, hydroxyethyl piperazine ethane sulfonic acid, sodium chloride.
Available as a single dose vial containing 43 mg irinotecan-free base at a concentration of 4.3 mg/mL
Ipsen Biopharmaceuticals, Inc.
More about Onivyde (irinotecan liposomal)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous antineoplastics
- En español
Related treatment guides
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.