Onivyde: Uses, Side Effects and Dosage

What is ONIVYDE used for?

ONIVYDE is used to treat adults (18 years of age and older) with metastatic pancreatic cancer (a type of cancer that starts in the pancreas and has already spread elsewhere in the

Serious Warnings and Precautions

body).

It is used:

• in patients who had their cancer progress after receiving another medicine called gemcitabine, and
• in combination with other cancer medicines called 5-fluorouracil (5-FU) and leucovorin (LV).

How does ONIVYDE work?

ONIVYDE belongs to a group of medicines called “topoisomerase inhibitors”. It is used in combination with other medicines to treat cancer. It blocks an enzyme that is involved in the division of cancer cells. This prevents these cells from multiplying and growing and they eventually die.

The medicine in ONIVYDE is held within small fatty particles called liposomes. The liposomes build up in the tumor and release the medicine slowly over time, which allows it to act for a longer period.

What are the ingredients in ONIVYDE?

Medicinal ingredient: Irinotecan (as sucrose octasulfate salt).

Non-medicinal ingredients: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid (HEPES), cholesterol, N-(carbonyl-methoxypolyethylene glycol-2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-2000-DSPE), sodium chloride, sucrose octasulfate, and water for injection.

ONVIYDE comes in the following dosage forms:

Suspension: 4.3 mg/mL of irinotecan (as sucrose octasulfate salt).

Do not use ONIVYDE if:

• you had a severe allergic reaction to any medicine containing irinotecan in the past.
• you are allergic to irinotecan or any of the ingredients in ONIVYDE.
• you are breast-feeding or planning to breast-feed.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ONIVYDE. Talk about any health conditions or problems you may have, including if you:

• have previously been given any medicine that contains irinotecan in any form as it may act differently than ONIVYDE. It is unknown if ONIVYDE provides a benefit in people who have previously received other medicines containing irinotecan.
• have had genetic testing done and been told that you are homozygous for the UGT1A1*28 allele (UGT1A1 7 / 7 genotype). This could increase your risk of getting neutropenia (decreased white blood cells).
• have or have had liver problems.
• have or have had kidney problems.
• have or have had bone marrow problems.
• have interstitial lung disease (ILD; scaring of the lung tissue) or

• are at a higher risk of developing ILD. This includes if you:

  • have or have had lung problems;
  • are taking pneumotoxic medicines that have a toxic effect on the lungs;
  • are taking medicines to increase your white blood cell count called colony stimulating factors;
  • have ever received radiation therapy.
• have recently received a vaccine or are going to receive a vaccine. Your response to the vaccine may be reduced.
• are underweight or have been told that you have a low body mass index (less than 18.5 kg / m²).
• have had a surgery on your pancreas known as a Whipple procedure.
• have a bowel obstruction (the flow of food and liquid in the intestines is blocked).
• are pregnant or planning to become pregnant.
• are at a higher risk of developing blood clots.
• are 75 years of age or older.

Other warnings you should know about:

ONIVYDE can cause the following serious side effects:

• Allergic reactions: Tell your healthcare professional right away if you experience any signs of an allergic reaction. This can include:

  • swelling under the skin (angioedema),
  • sudden shortness of breath or difficulty breathing,
  • flushing,
  • nausea,
  • headache,
  • skin rash or hives (itchy rash with swollen red bumps on the skin that appear suddenly),
  • itching,
  • swelling around the eyes, and
  • tightness in the chest or throat during the infusion or shortly after it.

Severe allergic reactions may be life threatening. The infusion may need to be stopped and you may need to be treated or observed for the side effects.

• Blood clots: Taking ONIVYDE can cause blood clots (thrombosis). These clots can be in the lung (pulmonary embolism), the veins (venous thrombosis), or the arteries (arterial thromboembolism). Contact your healthcare professional right away if you develop any signs or symptoms of a blood clot including:

  • swelling, pain, muscle spasms, tenderness or discolouration in the leg or arms;
  • chest pain, difficulty breathing, shortness of breath, coughing up blood;
  • slurred speech, face drooping to one side;
  • weakness, dizziness, headache.

See the Serious side effects and what to do about them table below for more information on these and other serious side effects.

Pregnancy, breast-feeding, and fertility:

Women:

• You should not receive ONIVYDE if you are pregnant as it may harm your baby.

  • You must tell your healthcare professional if you are or think you may be pregnant. Your healthcare professional may give you a pregnancy test before and during your treatment with ONIVYDE. Ask your healthcare professional for advice if you are planning to have a baby.
• During your ONIVYDE treatment and for 7 months after you receive your last dose, you should not become pregnant. Use an effective birth control method during this time. Talk to your healthcare professional for advice on effective methods of birth control.
• Do NOT take ONIVYDE if you are breast-feeding or planning to breast-feed. In addition, you should not breast-feed until one month after your last dose of ONIVYDE. Ask your healthcare professional if you are unsure.
• Prior to taking this medicine talk with your healthcare professional about the possible risks with this medicine and the options that may preserve your ability to have children.

Men:

• Use condoms if you have sex during your treatment and for at least four months after your last dose.

Driving and using machines:

ONIVYDE may affect your ability to drive or use machines. Before doing tasks which require special attention like driving, wait until you are feeling well again.

Testing and monitoring:

• ONIVYDE may cause abnormal blood test results.
• Your healthcare professional will monitor your health before, during, and after your treatment with ONIVYDE. This may include doing blood tests, monitoring signs of infections, and monitoring your lung function. Your healthcare professional may adjust your dose of ONIVYDE, delay treatment, or stop your treatment based on the results of these tests.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ONIVYDE:

• antibiotics, medicines used to treat bacterial infections (e.g., rifampin, rifabutin, azithromycin, clarithromycin, erythromycin, ciprofloxacin, and norfloxacin).
• antiepileptics, medicines used to treat and prevent seizures (e.g., carbamazepine, phenytoin, and phenobarbital).
• antifungals, medicines used to treat fungal infections (e.g., ketoconazole, fluconazole, itraconazole, and voriconazole)
• antiretrovirals, medicines used to treat HIV/AIDS (e.g., indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and atazanavir)
• calcium channel blockers, medicines used to treat high blood pressure and chest pain (e.g., diltiazem, verapamil, and nifedipine).
• cimetidine, a medicine used to treat stomach and intestine ulcers.
• gemfibrozil, a medicine used to treat high fat levels in the blood
• glucocorticoids, steroid medicines used to reduce inflammation.

• grapefruit juice. Do NOT drink grapefruit juice while receiving ONIVYDE.

• nefazodone, a medicine used to treat depression.
• St. John’s Wort, a herbal medicine.
• telaprevir, a medicine used to treat Hepatitis C.

How to take ONIVYDE:

• ONIVYDE will be prepared and given to you by a healthcare professional with experience in the use of cancer chemotherapy medicines.
• You will receive ONIVYDE into your veins (i.e., “intravenously” or “IV) over a period of 90 minutes. Your healthcare professional will then give you two other cancer medicines, leucovorin (LV) and 5-fluorouracil (5-FU).
• Follow all instructions given to you by your healthcare professional.
• Your healthcare professional may also give you other medicines to prevent nausea, vomiting, diarrhea, or allergic reactions.

Usual dose:

Your healthcare professional will decide how much and how long you should be treated with ONIVYDE. Your dose may depend on your condition, weight, age, if you are taking other medicines, and how you respond to ONIVYDE. Your dose will be repeated every two weeks.

Overdose:

What are possible side effects from using ONIVYDE?

These are not all the possible side effects you may have when taking ONIVYDE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of ONIVYDE may include:

• hair loss

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Your healthcare professional will store the unopened ONIVYDE vials for you in a refrigerator between 2^oC to 8^oC. ONIVYDE will be protected from light and freezing.

ONIVYDE is a cytotoxic drug. All applicable special handing and disposable procedures must be followed.

Keep out of reach and sight of children.

If you want more information about ONIVYDE:

• Talk to your healthcare professional.

• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website

  • (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website www.ipsen.ca or by calling 1-855-215-2288.

ONIVYDE and the ONIVYDE logo are trademarks of Ipsen Biopharm Ltd. used under license.

Last Revised: JUL 07, 2025