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Onivyde Side Effects

Generic name: irinotecan liposomal

Medically reviewed by Drugs.com. Last updated on Feb 27, 2025.

Note: This document provides detailed information about Onivyde Side Effects associated with irinotecan liposomal. Some dosage forms listed on this page may not apply specifically to the brand name Onivyde.

Applies to irinotecan liposomal: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Fatal neutropenic sepsis occurred in 0.8% of patients receiving irinotecan liposome.

Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving irinotecan liposome in combination with fluorouracil and leucovorin.

Withhold irinotecan liposome for absolute neutrophil count below 1500/mm(3) or neutropenic fever.

Monitor blood cell counts periodically during treatment.Severe diarrhea occurred in 13% of patients receiving irinotecan liposome in combination with fluorouracil and leucovorin.

Do not administer irinotecan liposome to patients with bowel obstruction.

Withhold irinotecan liposome for diarrhea of Grade 2 to 4 severity.

Administer loperamide for late diarrhea of any severity.

Administer atropine, if not contraindicated, for early diarrhea of any severity.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 7 months after the last dose. Male patients who have female partners should use effective birth control (eg, condoms) during treatment with this medicine and for 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Tell your doctor if you are using a medicine that contains irinotecan. Do not use Onivyde™ to substitute for other medicines containing irinotecan.

This medicine will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause severe diarrhea. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may cause a serious lung or breathing problem (eg, interstitial lung disease). Check with your doctor right away if you have cough, difficult breathing, or fever.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Serious side effects of Onivyde

Along with its needed effects, irinotecan liposomal (the active ingredient contained in Onivyde) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking irinotecan liposomal:

More common side effects

  • confusion
  • decreased urination
  • diarrhea (severe)
  • dizziness
  • dry mouth
  • fainting
  • fever
  • lightheadedness
  • pale skin
  • rapid breathing
  • sunken eyes
  • thirst
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • wrinkled skin

Less common side effects

  • black, tarry stools
  • chest pain or discomfort
  • chills
  • confusion
  • cough
  • fast heartbeat
  • lightheadedness, dizziness, or fainting
  • lower back or side pain
  • painful or difficult urination
  • rapid, shallow breathing
  • slow or irregular heartbeat
  • sore throat
  • trouble breathing
  • ulcers, sores, or white spots in the mouth

Incidence not known

  • chest tightness
  • hives, itching, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • reddening of the skin, especially around the ears

Other side effects of Onivyde

Some side effects of irinotecan liposomal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • decreased appetite
  • hair loss or thinning of the hair
  • lack or loss of strength
  • vomiting
  • weight loss

Less common side effects

  • feeling of warmth
  • increased sweating
  • sneezing
  • stomach pain
  • stuffy or runny nose
  • tearing of the eyes
  • watering of the mouth
  • weakness

For healthcare professionals

Applies to irinotecan liposomal: intravenous dispersion.

Gastrointestinal adverse events

Dermatologic

Hematologic

Hepatic

Local

Metabolic

Nervous system

Other

Renal

Immunologic

Musculoskeletal

Psychiatric

Respiratory

Cardiovascular

See also:

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2015) "Product Information. Onivyde (irinotecan liposomal)." Merrimack Pharmaceuticals

Further information

Onivyde side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.