Onivyde

Pronunciation: On-nee-vide
Generic name: irinotecan liposomal
Dosage form: liposomal injection for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 27, 2024.

What is Onivyde?

Onivyde (irinotecan liposomal) is an injectable prescription chemotherapy medicine that may be used to treat pancreatic cancer that has spread (metastasized) in adults. Onivyde is used in combination with:

• Oxaliplatin, fluorouracil, and leucovorin (the NALIRIFOX regimen) as a first-line treatment
• Fluorouracil and leucovorin, for those whose disease has progressed following the use of gemcitabine-based therapy.

Onivyde works in a unique way to treat pancreatic cancer. Onivyde contains irinotecan (a chemotherapy drug) packaged into tiny fat bubbles called liposomes (liposomal irinotecan). This allows Onivyde to stay in the blood longer than regular irinotecan and the liposomal bubbles are designed to dissolve near the pancreatic cancer, releasing the irinotecan where it is most effective. Once released, irinotecan is converted by the body into its active form, called SN-38. This substance damages cancer cell DNA, preventing the cancer cells from dividing and eventually causing them to die.

A recent study called NAPOLI 3 tested Onivyde as part of a combination treatment called NALIRIFOX. This study found that patients who received NALIRIFOX lived about 2 months longer on average than those who received a different standard treatment.

Onivyde gained FDA approval on October 22, 2015.

Onivyde side effects

The most common side effects of Onivyde are:

• fever or other signs of infection
• mouth sores
• diarrhea
• nausea or vomiting
• loss of appetite
• abdominal pain
• constipation
• weight loss
• laboratory changes
• feeling weak or tired
• inflammation in the mouth (stomatitis).

Serious side effects and warnings

Onivyde carries a Boxed Warning for severe neutropenia (low white blood cell counts) and severe diarrhea.

Severe or life-threatening neutropenia (low levels of a type of white blood cell) has been reported with Onivyde. Your healthcare provider will monitor your white blood cell count throughout your treatment. Contact them right away if you experience any symptoms such as fever, chills, feeling dizzy, or feeling short of breath.

Severe diarrhea. Diarrhea can start early (within 24 hours after being given Onivyde) or late (over 24 hours
after being given Onivyde). 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 antidiarrhea medicines (loperamide or atropine).

Onivyde can cause the following other serious side effects.

Serious lung problems (interstitial lung disease) which may be life-threatening or fatal. 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.

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. Contact your healthcare provider immediately if you are experiencing signs of infection, such as fever, chills, dizziness, or shortness of breath.

Allergic reactions (hypersensitivity). Products containing irinotecan including Onivyde can cause severe, life-threatening allergic reactions, including anaphylaxis. Seek immediate medical attention if you have 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.

Onivyde can cause harm to an unborn baby when administered to a pregnant woman (see pregnancy below).

Onivyde should not be used by itself for metastatic pancreatic cancer, it should always be given in combination with other treatments.

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.

Related/similar drugs

Before receiving Onivyde

You should not use this medicine if you are allergic to Onivyde, irinotecan, or any of the inactive ingredients in the injection.

Before receiving Onivyde, tell your healthcare provider about all your medical conditions, including if you:

• Have an infection
• Have liver or kidney disease
• Have lung disease
• Have an intestinal disorder or obstruction
• Have inflammatory bowel disease
• Already have diarrhea
• Are pregnant or intending to become pregnant
• Are breastfeeding.

Pregnancy

Onivyde can harm an unborn baby if the mother or the father is using this medicine. If you are a woman of childbearing potential, 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.

Breastfeeding

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 by a healthcare provider.

Premedication with a corticosteroid and an antiemetic 30 minutes before the infusion is usually given.

• 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.

• Follow the Onivyde Package Insert for instructions about how to minimize diarrhea.
• Call your doctor whenever you have diarrhea during your treatment with Onivyde.
• Your doctor may recommend keeping anti-diarrhea medicine on hand at all times (such as atropine, 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.
• Also keep up your fluid intake to make sure you do not become dehydrated.

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. 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.

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 other drugs will affect Onivyde?

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. Especially tell your healthcare provider if you take:

• Strong CYP3A4 inducers such as phenobarbital, phenytoin, rifampicin, St. John's Wort and glucocorticoids. Your healthcare provider may decide to substitute non-enzyme inducing therapies at least 2 weeks before starting Onivyde.
• Strong CYP3A4 inhibitors, such as clarithromycin, diltiazem, erythromycin, itraconazole, or ketoconazole
• UGT1A1 inhibitors (such as atazanavir).

This is not a complete list of interactions. See the Onivyde Prescribing Information for a full list.

Storage

Your healthcare provider will store Onivyde at 2°C to 8°C (36°F to 46°F) and protect from light. It should not be frozen.

Onivyde is a cytotoxic drug and all applicable special handling and disposal procedures should be followed

Onivyde ingredients

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.

Onivyde is made by Ipsen.

Available as a single dose vial containing 43 mg irinotecan-free base at a concentration of 4.3 mg/mL

Who makes Onivyde?

Ipsen Biopharmaceuticals, Inc. makes Onivyde.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer