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Onivyde

irinotecan liposomal
Topoisomerase I Inhibitor (Liposomal) FDA Approved 2015 Ipsen
Route
IV
Half-Life
~27 hrs
FDA Approved
2015
Manufacturer
Ipsen
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1. Indications and Usage

Pancreatic cancer: With 5-FU/LV after gemcitabine-based therapy.

2. Dosage and Administration

70 mg/m² IV Q2W. UGT1A1*28 homozygous: 50 mg/m².

3. Dosage Forms and Strengths

Injection: 43 mg/10 mL vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Severe Neutropenia: Fatal sepsis reported.
  • Severe Diarrhea: Early and late.
  • ILD: Fatal events reported.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (59%), Fatigue (56%), Vomiting (52%), Neutropenia (52%), Nausea (51%), Decreased Appetite (44%), Anemia (43%), Abdominal Pain (23%)

Diarrhea
59%
Fatigue
56%
Vomiting
52%
Neutropenia
52%
Nausea
51%
Decreased Appetite
44%
Anemia
43%
Abdominal Pain
23%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

CYP3A4 Inhibitors/Inducers: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Liposomal irinotecan converts to SN-38, inhibiting topoisomerase I causing lethal DNA breaks.

Pharmacokinetics

Liposomal irinotecan t½: 26.8h. SN-38 t½: 68h.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Onivyde Trials on ClinicalTrials.gov ↗ 📚 PubMed: Onivyde Clinical Trials ↗
FDA-Approved Tumor Types

Onivyde has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Pancreatic Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Onivyde. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Onivyde (irinotecan liposomal) approved for?

Onivyde (irinotecan liposomal) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Onivyde (irinotecan liposomal) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Onivyde (irinotecan liposomal) work?

Liposomal irinotecan converts to SN-38, inhibiting topoisomerase I causing lethal DNA breaks.

What are the most common side effects?

Diarrhea (59%), Fatigue (56%), Vomiting (52%), Neutropenia (52%), Nausea (51%), Decreased Appetite (44%), Anemia (43%), Abdominal Pain (23%) Diarrhea 59% Fatigue 56% Vomiting 52% Neutropenia 52% Nausea 51% Decreased Appetite 44% Anemia 43% Abdominal Pain 23%

← All Therapies Full Prescribing Information ↗