FLOXURIDINE

Post-LOE

floxuridine

Hikma

ANDAINJECTIONINJECTABLE

Approved

Apr 2000

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

FLOXURIDINE (floxuridine) by Hikma is clinical pharmacology when floxuridine is given by rapid intra-arterial injection it is apparently rapidly catabolized to 5-fluorouracil. Approved for antimetabolite [epc]. First approved in 2000.

Drug data last refreshed 19h ago

Mechanism of Action

CLINICAL PHARMACOLOGY When floxuridine is given by rapid intra-arterial injection it is apparently rapidly catabolized to 5-fluorouracil. Thus, rapid injection of floxuridine produces the same toxic and antimetabolic effects as does 5-fluorouracil. The primary effect is to interfere with the…

Pharmacologic Class:

Antimetabolite

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (5)

NCT04251715Phase 2Active Not Recruiting

mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma

Started Apr 2021

5 enrolled

Liver and Intrahepatic Bile Duct CarcinomaStage III Intrahepatic Cholangiocarcinoma AJCC v8Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8+3 more

NCT00361842Phase 2Completed

Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer

Started Jul 2006

65 enrolled

Colorectal Neoplasms

NCT00645710Phase 1/2Completed

Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery

Started Feb 2005

NCT00063960Phase 2Completed

Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer

Started Aug 2003

94 enrolled

Colorectal CancerMetastatic Cancer

NCT00695201Phase 1Completed

Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer

Started Aug 2000

52 enrolled

Colon CancerRectal Cancer

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.