Our latest edition of the Guidelines+ Monographs Series will delve into the medication irinotecan liposome injection, marketed under the brand name Onivyde® by Ipsen. Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan used in the treatment of pancreatic adenocarcinoma. Onivyde is indicated in combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma and in combination with fluorouracil and leucovorin, as well as for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. It was initially approved in 1996.
In the following sections, we will provide a comprehensive overview of irinotecan liposome injection and analyze its positioning across various guidelines for its approved indications.
Note* – This Guidelines+ Monographs for irinotecan liposome injection (Onivyde) is current as of December 2024. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview
- Brand name: Onivyde
- Generic name: irinotecan liposome injection
- Manufacturer(s): Ipsen
- Initial FDA Approval: 1996
Indications and FDA Approval Details
| Indicated Condition | Indicated | Age Range | Date Approved |
|---|---|---|---|
| Influenza | for the treatment of Influenza in Children Aged Five and Older and to prevent influenza in children aged five and older following contact with an infected person. | 5 years of age and older | August 11, 2022 |
| Influenza | as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). | 12 years of age and older | November 23, 2020 |
| Influenza | for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. | 12 years of age and older | October 17, 2019 |
| Influenza | for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. | 12 years of age and older | October 24, 2018 |
WARNING: SEVERE NEUTROPENIA and SEVERE DIARRHEA
See full prescribing information for complete boxed warning
- Neutropenia
- Severe or life-threatening neutropenia , including fatal neutropenic sepsis and fatal neutropenic fever, has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Withhold ONIVYDE for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.
- Diarrhea
- Severe and life-threatening diarrhea has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Do not administer ONIVYDE to patients with bowel obstruction. Withhold ONIVYDE for diarrhea of Grade 2-4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.
Dosage and Administration
Do not substitute ONIVYDE for other drugs containing irinotecan HCl.
ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin:
- Recommended dose of ONIVYDE is 50 mg/m² intravenous infusion over 90 minutes every two weeks.
- Recommended starting dose of ONIVYDE in patients homozygous for UGT1A1*28 is 50 mg/m2 every two weeks.
- There is no recommended dose of ONIVYDE for patients with serum bilirubin above the upper limit of normal.
- ONIVYDE in combination with fluorouracil and leucovorin:
- Recommended dose of ONIVYDE is 70 mg/m2 intravenous infusion over 90 minutes every two weeks.
- Recommended starting dose of ONIVYDE in patients homozygous for UGT1A1*28 is 50 mg/m2 every two weeks.
- There is no recommended dose of ONIVYDE for patients with serum bilirubin above the upper limit of normal.
- Premedicate with a corticosteroid and an anti-emetic 30 minutes prior to ONIVYDE.
Dosage Forms and Strengths
- Injection: 43 mg/10 mL (4.3 mg/mL) single dose vial
Contraindications
Severe hypersensitivity reaction to ONIVYDE or irinotecan HCl.
Warnings and Precautions
- Interstitial lung disease (ILD): Fatal ILD has occurred in patients receiving irinotecan HCl. Discontinue ONIVYDE if ILD is diagnosed.
- Severe hypersensitivity reaction: Permanently discontinue ONIVYDE for severe hypersensitivity reactions.
- Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Adverse Reactions
The most common adverse reactions (reported in ≥ 20% of patients) were for: • ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin: diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight. The most common laboratory abnormalities (≥ 10% Grade 3 or 4) were decreased neutrophils, decreased potassium, decreased lymphocytes, and decreased hemoglobin. (6.1) • ONIVYDE in combination with fluorouracil and leucovorin: diarrhea, fatigue/asthenia, vomiting, nausea, decreased appetite, stomatitis, and pyrexia. The most common laboratory abnormalities (≥ 10% Grade 3 or 4) were lymphopenia and neutropenia.
Drug Interactions
- Strong CYP3A4 Inducers: Avoid the use of strong CYP3A4 inducers if possible. Substitute non-enzyme inducing therapies at least 2 weeks prior to initiation of ONIVYDE. (7.1)
- Strong CYP3A4 Inhibitors: Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible; discontinue strong CYP3A4 inhibitors at least 1 week prior to starting therapy.
Now that we’ve covered the basic monograph information for Onivyde, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Irinotecan Liposome Injection in the Guidelines
- Pancreatic Adenocarcinoma
- Version 2.2021, NCCN Clinical Practice Guidelines in Oncology
- Publication Date: 01 April 1 2021
- The FDA has approved the use of Irinotecan liposomal injection in combination with 5-FU/leucovorin as a secondary treatment option for patients with metastatic disease following gemcitabine-based therapy. This regimen is recommended by the panel for patients who have a good performance status and are experiencing disease progression.
- Metastatic Pancreatic Cancer
- American Society of Clinical Oncology
- Publication: August 05, 2020
- Recommendation 3.7. Gemcitabine or fluorouracil can be considered as second-line therapy for patients who have either an ECOG PS of 2 or a comorbidity profile that precludes more aggressive regimens and who wish to pursue cancer-directed therapy (the addition of nab-paclitaxel to gemcitabine or nanoliposomal irinotecan to fluorouracil may be offered in this setting, with proactive dose and schedule adjustments to minimize toxicities).
This concludes our Guidelines+ Monographs for irinotecan liposome injection (Onivyde). This list is current as of December 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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