Floxuridine: Drug information

For additional information see "Floxuridine: Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Experienced physician:

It is recommended that floxuridine be given only by or under the supervision of a qualified health care provider who is experienced in cancer chemotherapy and intra-arterial drug therapy and is well versed in the use of potent antimetabolites.

Appropriate use:

Because of the possibility of severe toxic reactions, all patients should be hospitalized for initiation of the first course of therapy.

Pharmacologic Category

Antineoplastic Agent, Antimetabolite;
Antineoplastic Agent, Antimetabolite (Pyrimidine Analog)

Dosing: Adult

Cholangiocarcinoma, intrahepatic metastases, unresectable

Cholangiocarcinoma, intrahepatic metastases, unresectable (off-label use/combination): Hepatic artery infusion (HAI): 0.12 mg/kg/day (with dexamethasone and heparin) as a continuous infusion for 14 days starting on day 1 of a 4-week cycle (in combination with gemcitabine and oxaliplatin; IV chemotherapy administered on day 15 of cycle 1 [MSKCC regimen] or on days 1 and 15 of cycle 1 [Washington University regimen] and on days 1 and 15 of each subsequent 4-week cycle) until disease progression or unacceptable toxicity (Ref).

Colorectal cancer, intrahepatic metastases

Colorectal cancer, intrahepatic metastases:

Colorectal cancer, intrahepatic metastases, unresectable (off-label combination): HAI: 0.12 mg/kg/day (with dexamethasone and heparin) as a continuous infusion for 14 days starting on day 1 of a 4-week cycle (in combination with irinotecan and oxaliplatin or irinotecan, fluorouracil, and leucovorin; IV chemotherapy administered on days 1 and 15 of each 4-week cycle) until resectability, disease progression, or unacceptable toxicity (Ref).

Colorectal cancer, intrahepatic metastases, resectable (off-label combination): Note: Begin treatment at least 4 weeks following resection of liver metastases. HAI: 0.14 mg/kg/day (with dexamethasone and heparin) as a continuous infusion for 14 days beginning on day 15 of a 5-week cycle for 6 cycles (in combination with 6 cycles of fluorouracil and leucovorin; IV chemotherapy administered on day 1 of each 5-week cycle) (Ref), or 0.12 mg/kg/day (with dexamethasone and heparin) as a continuous infusion for 14 days beginning on day 1 of a 5-week cycle for 6 cycles (in combination with 6 cycles of oxaliplatin, fluorouracil, and leucovorin or irinotecan, fluorouracil, and leucovorin; IV chemotherapy administered on days 15 and 29 of each 5-week cycle) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with extreme caution.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with extreme caution. The following dosage adjustments have been described in literature (refer to articles for more detail).

**Floxuridine Recommended Dosage Modifications for Hepatic Impairment**
AST^a
Baseline value^b	Current value^c	Floxuridine dosage modification
^aZalcberg 2004.
^b Baseline value: Laboratory value obtained on the day the patient received the last floxuridine dose.
^c Current value: Laboratory value obtained on pump emptying day or on the day of planned treatment (whichever is higher).
^d Floyd 2006.
Baseline AST ≤50 units/L	<3 × baseline	Administer 100% of the floxuridine dose.
	3 to <4 × baseline	Administer 80% of the floxuridine dose.
	4 to <5 × baseline	Administer 50% of the floxuridine dose.
	≥5 × baseline	Withhold floxuridine until AST <4 × baseline; resume at 50% of last dose administered.
Baseline AST >50 units/L	<2 × baseline	Administer 100% of the floxuridine dose.
	2 to <3 × baseline	Administer 80% of the floxuridine dose.
	3 to <4 × baseline	Administer 50% of the floxuridine dose.
	≥4 × baseline	Withhold floxuridine until AST <3 × baseline; resume at 50% of last dose administered.
Alkaline phosphatase^a
Baseline value^b	Severity	Floxuridine dosage modification
Baseline alkaline phosphatase ≤90 units/L	<1.5 × baseline	Administer 100% of the floxuridine dose.
	1.5 to <2 × baseline	Administer 50% of the floxuridine dose.
	≥2 × baseline	Withhold floxuridine until alkaline phosphatase <1.5 × baseline; resume at 25% of last dose administered.
Baseline alkaline phosphatase >90 units/L	<1.2 × baseline	Administer 100% of the floxuridine dose.
	1.2 to 1.5 × baseline	Administer 50% of the floxuridine dose.
	≥1.5 × baseline	Withhold floxuridine until alkaline phosphatase <1.2 × baseline; resume at 25% of last dose administered.
Serum bilirubin^a
Baseline value^b	Severity	Floxuridine dosage modification
Baseline serum bilirubin ≤1.2 mg/dL	<1.5 × baseline	Administer 100% of the floxuridine dose.
	1.5 to <2 × baseline	Administer 50% of the floxuridine dose.
	≥2 × baseline	Withhold floxuridine until serum bilirubin <1.5 × baseline; resume at 25% of last dose administered.
Baseline serum bilirubin >1.2 mg/dL	<1.2 × baseline	Administer 100% of the floxuridine dose.
	1.2 to <1.5 × baseline	Administer 50% of the floxuridine dose.
	≥1.5 × baseline	Withhold floxuridine until alkaline phosphatase <1.2 × baseline; resume at 25% of last dose administered.
Serum bilirubin, transaminases, or alkaline phosphatase^d
Serum bilirubin ≥1.2 × ULN to <1.5 × ULN or alkaline phosphatase ≥1.2 × ULN to <1.5 × ULN		Administer 80% of the floxuridine dose.
Serum bilirubin ≥1.5 × ULN to <2 × ULN, transaminases 3 × baseline, or alkaline phosphatase ≥1.5 × ULN to <2 × ULN		Administer 50% of the floxuridine dose.
Serum bilirubin ≥2 × ULN, transaminases >3 × baseline, or alkaline phosphatase ≥2 × ULN		No recommendation is available.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m²: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m²; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref). Note: Some studies and clinical experience recommend the use of ideal body weight (IBW) (or actual body weight if less than IBW) or an adjusted body weight in patients ≥25% above IBW (Ref). Refer to individual protocols for dosing weight recommendations.

Dosing: Adjustment for Toxicity: Adult

Withhold therapy for adverse reactions; may resume if adverse reaction subsides.

Hematologic: Discontinue for white blood count <3,500/mm³ (or with rapid decline) or for platelet count <100,000/mm³.

Nonhematologic toxicity: Discontinue for myocardial ischemia, stomatitis/esophagopharyngitis, vomiting (intractable), diarrhea (or frequent/watery stools), gastrointestinal ulceration/bleeding, hemorrhage (from any site).

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Diarrhea (may be dose limiting), stomatitis

Hematologic & oncologic: Anemia, bone marrow depression (nadir: 7-10 days; may be dose limiting), leukopenia, thrombocytopenia

1% to 10%:

Dermatologic: Alopecia, dermatitis, localized erythema, skin hyperpigmentation, skin photosensitivity

Gastrointestinal: Anorexia, biliary sclerosis, cholecystitis

Hepatic: Jaundice

<1%, postmarketing, and/or case reports: Abdominal cramps, abdominal pain, BSP abnormality, change in prothrombin time, decreased erythrocyte sedimentation rate, decreased serum total protein, duodenal ulcer, duodenitis, enteritis, fever, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal ulcer, glossitis, hemorrhage, hepatic abscess, increased erythrocyte sedimentation rate, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum bilirubin, increased serum total protein, increased serum transaminases, infusion related reaction (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), ischemic heart disease, lethargy, malaise, nausea, pharyngitis, skin rash, vomiting, weakness

Contraindications

Poor nutritional states; depressed bone marrow function; potentially serious infections.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Floxuridine may cause severe hematologic toxicity; anemia, leukopenia, and thrombocytopenia commonly occur. The nadir is usually at 7 to 10 days (Perry 2012).

• Cardiovascular toxicity: Myocardial ischemia has been reported with floxuridine treatment.

• GI toxicity: May cause GI toxicity, including diarrhea, intractable vomiting, stomatitis, esophagopharyngitis, GI ulceration, and GI hemorrhage.

• Hemorrhage: Bleeding may occur with floxuridine treatment.

• Severe toxic reactions: The manufacturer recommends that patients be hospitalized for initiation of the first treatment course. Severe toxicities may occur with floxuridine; cases may be fatal. Severe toxicities are more likely to occur in poor-risk patients, patients with prior pelvic irradiation, or in those who have received prior alkylating agents; use with extreme caution.

Concurrent drug therapy issues:

• Bevacizumab: In clinical studies, the addition of IV bevacizumab to floxuridine administered as a hepatic artery infusion resulted in increased biliary toxicity without evidence of improvement in clinical outcomes (Cercek 2014; D’Angelica 2015).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection:

Generic: 0.5 g (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (reconstituted) (Floxuridine Injection)

0.5 g (per each): $4,679.89

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Intra-arterial: Administer as a continuous hepatic intra-arterial infusion using an infusion pump. Floxuridine should be given only by or under the supervision of a qualified health care provider who is experienced in cancer chemotherapy and intra-arterial drug therapy.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Use: Labeled Indications

Colorectal cancer, intrahepatic metastases: Palliative management of hepatic metastases of colorectal cancer (administered by continuous regional hepatic intra-arterial infusion) in select patients considered incurable by surgical resection or other means.

Limitation of use: Patients with known disease extending beyond an area capable of a single artery infusion should (in most cases) be considered for systemic therapy with other chemotherapy agents.

Use: Off-Label: Adult

Cholangiocarcinoma, intrahepatic metastases, unresectable

Medication Safety Issues

Sound-alike/look-alike issues:

Floxuridine may be confused with Fludara, fludarabine, fluorouracil

FUDR may be confused with Fludara

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Administration issues:

Floxuridine is highly toxic with a narrow margin of safety. Use care when prescribing and/or administering floxuridine solution via hepatic artery infusion (HAI). HAI devices may have variable reservoir volumes and flow rates. Refer to specific protocol and infusion device instructions for use to ensure patient receives the intended dose of HAI floxuridine.

Metabolism/Transport Effects

Inhibits CYP2C9 (Weak);

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Allopurinol: May decrease active metabolite exposure of Fluorouracil Products. Risk X: Avoid

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Amisulpride (Oral): May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Fluorouracil Products. Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cimetidine: May increase serum concentration of Fluorouracil Products. Risk C: Monitor

Cladribine: Agents that Undergo Intracellular Phosphorylation may decrease therapeutic effects of Cladribine. Risk X: Avoid

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: May increase QTc-prolonging effects of Fluorouracil Products. Fluorouracil Products may increase myelosuppressive effects of CloZAPine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Dabrafenib: Fluorouracil Products may increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Domperidone: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Domperidone. Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Fexinidazole: Fluorouracil Products may increase myelosuppressive effects of Fexinidazole. Fexinidazole may increase QTc-prolonging effects of Fluorouracil Products. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Fluorouracil Products: May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Folic Acid: May increase adverse/toxic effects of Fluorouracil Products. Risk C: Monitor

Fosphenytoin-Phenytoin: CYP2C9 Inhibitors (Weak) may increase serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor

Gimeracil: May increase serum concentration of Fluorouracil Products. Risk X: Avoid

Haloperidol: May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Interferons (Alfa): May increase serum concentration of Fluorouracil Products. Risk C: Monitor

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Leucovorin Calcium-Levoleucovorin: May increase adverse/toxic effects of Fluorouracil Products. Risk C: Monitor

Levoketoconazole: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Levoketoconazole. Risk X: Avoid

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

MetroNIDAZOLE (Systemic): May increase serum concentration of Fluorouracil Products. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Ondansetron: May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification

Pentamidine (Systemic): May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Pimozide: May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk X: Avoid

Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor

Piperaquine: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

QT-prolonging Agents (Highest Risk): May increase QTc-prolonging effects of Fluorouracil Products. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Antidepressants (Moderate Risk): Fluorouracil Products may increase QTc-prolonging effects of QT-prolonging Antidepressants (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Antipsychotics (Moderate Risk): May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Kinase Inhibitors (Moderate Risk): Fluorouracil Products may increase QTc-prolonging effects of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Miscellaneous Agents (Moderate Risk): May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Quinolone Antibiotics (Moderate Risk): May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sertindole: May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Thioridazine: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

TOLBUTamide: CYP2C9 Inhibitors (Weak) may increase serum concentration of TOLBUTamide. Risk C: Monitor

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vitamin K Antagonists: Fluorouracil Products may increase serum concentration of Vitamin K Antagonists. Management: Monitor INR and for signs/symptoms of bleeding closely when a fluorouracil product is combined with a vitamin K antagonist (eg, warfarin). Anticoagulant dose adjustment will likely be necessary. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Patients who could become pregnant should avoid pregnancy during floxuridine treatment.

Pregnancy Considerations

Adverse effects have been observed in animal reproduction studies. In utero exposure to floxuridine may cause fetal harm. Medications that inhibit DNA synthesis are known to be teratogenic in humans.

Breastfeeding Considerations

It is not known if floxuridine is present in breast milk.

The manufacturer recommends against breastfeeding during floxuridine treatment.

Monitoring Parameters

Monitor CBC with differential; liver function (bilirubin, alkaline phosphatase, and transaminases); monitor for signs/symptoms of stomatitis/esophagopharyngitis, gastrointestinal ulceration/bleeding, hemorrhage, vomiting, and/or diarrhea.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Floxuridine is catabolized to fluorouracil after intra-arterial administration, resulting in activity similar to fluorouracil; inhibits thymidylate synthetase and disrupts DNA and RNA synthesis.

Pharmacokinetics (Adult Data Unless Noted)

Metabolism: Hepatic; Active metabolites: Floxuridine monophosphate (FUDR-MP) and fluorouracil; Inactive metabolites: Urea, CO₂, α-fluoro-β-alanine, α-fluoro-β-guanidopropionic acid, α-fluoro-β-ureidopropionic acid, and dihydrofluorouracil

Excretion: Urine (as fluorouracil, urea, α-fluoro-β-alanine, α-fluoro-β-guanidopropionic acid, α-fluoro-β-ureidopropionic acid, and dihydrofluorouracil; Respiratory (as exhaled gases [CO₂])

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(FR) France: Fudr;
(IN) India: Fudr;
(PR) Puerto Rico: Fudr

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Topic 8942 Version 256.0

خرید پکیج

Floxuridine: Drug information