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Topoisomerase Inhibitor • Prescription (Rx)

Irinotecan Hydrochloide

Brand Names: Irinotecan Hydrochloide Generic

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-08-26 • RxNorm RxCUI 1726319 • 9 Linked .gov / PubMed Citations • Governance: Dr. Marcus Thorne, MD, FACC (NPI #1184629314)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Irinotecan Hydrochloide Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

76%
Patient “Worth It” (17)
$28.75
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Irinotecan Hydrochloide Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1726319 • NDC 68001-480

Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for: ; First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum.

12.1 Mechanism of Action Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks. Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN-38.

Clinical clearance of Irinotecan Hydrochloide (Topoisomerase Inhibitor) relies on primary cyp3a4 cytochrome processing paired with glucuronide elimination for irinotecan hydrochloide with a 6 to 12 hours terminal elimination (Irinotecan Hydrochloide SPL) half-life; patients absorbing at Complete (~100%) parenteral systemic delivery for Irinotecan Hydrochloide (20 mg/mL Injection) bioavailability typically observe target onset around rapid intravascular/parenteral onset within 15–45 minutes after irinotecan hydrochloide administration.

FDA clinical labeling for Irinotecan Hydrochloide restricts administration in 4 contraindications; irinotecan hydrochloride injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.; hypersensitivity to irinotecan hydrochloride injection or its excipients (4) across 20 mg/mL Injection, 125 mg, 20 mg, with self-reported patient tracking dominated by nausea (11% of reports), diarrhea (8.3% of reports), constipation (5.5% of reports).

CYP450 & Metabolic Pathways: CYP3A4
Key Monitored Interactions:
CYP3A4 Metabolic Inhibitors & Inducers Moderate

Potent CYP3A4 modulators alter hepatic clearance of Irinotecan Hydrochloide, shifting steady-state plasma concentrations.

Duplicate Topoisomerase Inhibitor Agents Moderate

Avoid overlapping topoisomerase inhibitor prescriptions alongside Irinotecan Hydrochloide to prevent cumulative receptor toxicity.

Half-Life
6 to 12 hours terminal elimination (Irinotecan Hydrochloide SPL)
Bioavailability
Complete (~100%) parenteral systemic delivery for Irinotecan Hydrochloide (20 mg/mL Injection)
Metabolism & Clearance
Primary CYP3A4 cytochrome processing paired with glucuronide elimination for Irinotecan Hydrochloide
Clinical Onset
Rapid intravascular/parenteral onset within 15–45 minutes after Irinotecan Hydrochloide administration

Standard Adult Titration & Dosages

20 mg/mL Injection 125 mg 20 mg

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS
  • Irinotecan hydrochloride injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.
  • Hypersensitivity to irinotecan hydrochloride injection or its excipients (4)

Logged Side-Effect Incidence (17 Reports)

Nausea 11%
Diarrhea 8.3%
Constipation 5.5%
Vomiting 4.6%
Decreased appetite 3.9%
Abdominal discomfort 3.8%
Elena Rostova (AI Biostatistician & openFDA Quant)

Irinotecan Hydrochloide Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (17)
Nausea FAERS: 11% • Logs: 11%
Diarrhea FAERS: 8.3% • Logs: 8.3%
Vomiting FAERS: 4.6% • Logs: 4.6%
Constipation FAERS: 5.5% • Logs: 5.5%
Decreased appetite FAERS: 3.9% • Logs: 3.9%
Abdominal discomfort FAERS: 3.8% • Logs: 3.8%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Irinotecan Hydrochloide)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Predicting acute diarrhoea in rectal cancer chemoradiotherapy: Secondary analysis

The multi-institutional cohort of 73 centres strengthens the reliability of these findings, demonstrating the model's potential as a strategic tool to individualise rectal cancer treatment while mitigating severe diarrhoea.

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology • 2025-09-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 40618901 ↗
Can This Approach Help? Inside the Latest Research on Differences in efficacy of biweekly irinotecan plus cisplatin versus irinotecan

BIRIP was an effective treatment option that may improve survival outcomes among patients with AGC without previous gastrectomy.

International journal of clinical oncology • 2025-02-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 39585516 ↗
Can This Approach Help? Inside the Latest Research on Modeling Tumor Growth Using Partly Conditional Survival Models: A Case Study in

The PC modeling approach offers flexible characterization of associations between longitudinal covariates, such as serially assessed tumor burden, and survival time.

JCO clinical cancer informatics • 2023-09-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 37713655 ↗
Can This Approach Help? Inside the Latest Research on Phase III randomized trial comparing systemic versus intra-arterial oxaliplatin,

This study is planned to include 348 patients to demonstrate the superiority of HAI-ox over systemic oxaliplatin in first-line CRCLM treatment (NCT02885753).

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver • 2022-03-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 35027324 ↗
New Insights on Phase III Trial of Ramucirumab Beyond Progression Plus Irinotecan in Patients: What a 202-Participant Study Found

Adding ramucirumab to irinotecan does not provide a significant advantage in OS over irinotecan alone in patients with AGC who have progressed during ramucirumab-containing chemotherapy.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology • 2025-07-15 • Phase III Randomized Trial
N = 202 82/100 PMID 40408613 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Irinotecan Hydrochloide Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1726319
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.5000/unit (~$15.00/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $70.44 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 17 Anonymous DotMD Community Micro-Logs $28.75 / mo View logs ↓

Irinotecan Hydrochloide Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Irinotecan Hydrochloide RxNorm Concept ID 1726319 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.5000 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $70.44 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $28.75 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 76.00% Worth It (17 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Irinotecan Hydrochloide Patient Community, Cohort Filters & Dosage Logs

Cross-verified Irinotecan Hydrochloide (topoisomerase inhibitor) monograph synthesizing RxNorm 1726319, openFDA FAERS signals, and $28.75–$70.44 cash benchmarks.

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