pharmacopeia
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/api/v1/drug/floxuridine

Boxed warning

It is recommended that floxuridine be given only by or under the supervision of a qualified physician who is experienced in cancer chemotherapy and intra-arterial drug therapy and is well versed in the use of potent antimetabolites. Because of the possibility of severe toxic reactions, all patients should be hospitalized for initiation of the first course of therapy.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.

Nucleic Acid Synthesis

Indications

Sourced from openFDA
  • Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.

Contraindications

Sourced from openFDA
  • Floxuridine therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function or those with potentially serious infections.contraindicated

Dosage & administration

Sourced from openFDA

Each vial must be reconstituted with 5 mL of sterile water for injection to yield a solution containing approximately 100 mg of floxuridine/mL. The calculated daily dose(s) of the drug is then diluted with 5% dextrose or 0.9% sodium chloride injection to a volume appropriate for the infusion apparatus to be used. The administration of floxuridine is best achieved with the use of an appropriate pump to overcome pressure in large arteries and to ensure a uniform rate of infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The recommended therapeutic dosage schedule of floxuridine by continuous arterial infusion is 0.1 to 0.6 mg/kg/day. The higher dosage ranges (0.4 to 0.6 mg) are usually employed for hepatic artery infusion because the liver metabolizes the drug, thus reducing the potential for systemic toxicity. Therapy can be given until adverse reactions appear. (See PRECAUTIONS section.) When these side effects have subsided, therapy may be resumed. The patient should be maintained on therapy as long as response to floxuridine continues. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Warnings & precautions

Sourced from openFDA

BECAUSE OF THE POSSIBILITY OF SEVERE TOXIC REACTIONS, ALL PATIENTS SHOULD BE HOSPITALIZED FOR THE FIRST COURSE OF THERAPY. Floxuridine should be used with extreme caution in poor risk patients with impaired hepatic or renal function or a history of high-dose pelvic irradiation or previous use of alkylating agents. The drug is not intended as an adjuvant to surgery. Floxuridine may cause fetal harm when administered to a pregnant woman. It has been shown to be teratogenic in the chick embryo, mouse (at doses of 2.5 to 100 mg/kg) and rat (at doses of 75 to 150 mg/kg). Malformations included cleft palates; skeletal defects; and deformed appendages, paws and tails. The dosages which were teratogenic in animals are 4.2 to 125 times the recommended human therapeutic dose. There are no adequate and well-controlled studies with floxuridine in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Combination Therapy Any form of therapy which adds to the stress of the patient, interferes with nutrition or depresses bone marrow function will increase the toxicity of floxuridine.

Adverse reactions

Sourced from openFDA

Adverse reactions to the arterial infusion of floxuridine are generally related to the procedural complications of regional arterial infusion. The more common adverse reactions to the drug are nausea, vomiting, diarrhea, enteritis, stomatitis and localized erythema. The more common laboratory abnormalities are anemia, leukopenia, thrombo-cytopenia and elevations of alkaline phosphatase, serum transaminase, serum bilirubin and lactic dehydrogenase. Other adverse reactions are: Gastrointestinal: duodenal ulcer, duodenitis, gastritis, bleeding, gastroenteritis, glossitis, pharyngitis, anorexia, cramps, abdominal pain; possible intra- and extrahepatic biliary sclerosis, as well as acalculous cholecystitis. Dermatologic: alopecia, dermatitis, nonspecific skin toxicity, rash. Cardiovascular: myocardial ischemia. Miscellaneous Clinical Reactions: fever, lethargy, malaise, weakness. Laboratory Abnormalities: BSP, prothrombin, total proteins, sedimentation rate and thrombopenia. Procedural Complications of Regional Arterial Infusion: arterial aneurysm; arterial ischemia; arterial thrombosis; embolism; fibromyositis; thrombophlebitis; hepatic necrosis; abscesses; infection at catheter site; bleeding at catheter site; catheter blocked, displaced or leaking. The following adverse reactions have not been reported with floxuridine but have been noted following the administration of 5-fluorouracil.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: Pregnancy Category D See WARNINGS section. Floxuridine has been shown to be teratogenic in the chick embryo, mouse (at doses of 2.5 to 100 mg/kg) and rat (at doses of 75 to 150 mg/kg). Malformations included cleft palates, skeletal defects and deformed appendages, paws and tails. The dosages which were teratogenic in animals were 4.2 to 125 times the recommended human therapeutic dose. There are no adequate and well-controlled studies with floxuridine in pregnant women. While there is no evidence of teratogenicity in humans due to floxuridine, it should be kept in mind that other drugs which inhibit DNA synthesis (e.g., methotrexate and aminopterin) have been reported to be teratogenic in humans. Floxuridine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Floxuridine has not been studied in animals for its effects on peri- and postnatal development. However, compounds which inhibit DNA, RNA and protein synthesis might be expected to have adverse effects on peri- and postnatal development.

Overdosage

Sourced from openFDA

The possibility of overdosage with floxuridine is unlikely in view of the mode of administration. Nevertheless, the anticipated manifestations would be nausea, vomiting, diarrhea, gastrointestinal ulceration and bleeding, bone marrow depression (including thrombocytopenia, leukopenia and agranulocytosis). No specific antidotal therapy exists. Patients who have been exposed to an overdosage of floxuridine should be monitored hematologically for at least 4 weeks. Should abnormalities appear, appropriate therapy should be utilized. The acute intravenous toxicity of floxuridine is as follows: LD 50 Species (mg/kg ± S.E.) Mouse 880 ± 51 Rat 670 ± 73 Rabbit 94 ± 19.6 Dog 157 ± 46

Approval history

Sourced from openFDA
  • Apr 6, 2000ANDAANDA075387Hikma
  • Feb 22, 2001ANDAANDA075837Fresenius Kabi Usa

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
143 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective149.8%
  2. 2Diarrhoea139.1%
  3. 3Hepatic Steatosis139.1%
  4. 4Steatohepatitis128.4%
  5. 5Alanine Aminotransferase Increased107.0%
  6. 6Tachycardia96.3%
  7. 7Death85.6%
  8. 8Nausea85.6%
  9. 9Neutropenia85.6%
  10. 10Aspartate Aminotransferase Increased74.9%
  11. 11Abdominal Pain64.2%
  12. 12Tumour Lysis Syndrome64.2%
  13. 13Blood Alkaline Phosphatase Increased53.5%
  14. 14Bone Marrow Failure53.5%
  15. 15Hepatic Failure53.5%

Literature

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Recent PubMed references pinned to Floxuridine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 68 ClinicalTrials.gov registrations naming Floxuridine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Floxuridine work?
Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.
What is Floxuridine used for?
According to FDA labeling, Floxuridine carries indications including: Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Floxuridine?
Floxuridine is classified as Pyrimidine analogues, Antimetabolite, Nucleic Acid Synthesis Inhibitors, Decreased DNA Integrity, Decreased Hematopoiesis, Decreased RNA Integrity.
What are the contraindications for Floxuridine?
Floxuridine labeling lists contraindications including: Floxuridine therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function or those with potentially serious infections.. Always consult the full prescribing information and a clinician.
Note. Data for floxuridine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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