fluorouracil (Rx)

Brand and Other Names:Adrucil
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50mg/mL

Colon and Rectum Cancer

400 mg/m² IVP on Day 1, followed by 2400-3000 mg/m² IV as a continuous infusion over 46 hr q2Weeks in combination with leucovorin with or without oxaliplatin/irinotecan

Breast Cancer

500 or 600 mg/m² IV on Days 1 and 8 q28Days for 6 cycles as a component of a cyclophosphamide-based multidrug regimen

Gastric Cancer

200-1000 mg/m²/day as a continuous infusion over 24 hr (as part of a platinum-containing regimen)

Duration and frequency of each cycle varies based on dose and regimen

Pancreatic Cancer

400 mg/m² IVP on Day 1, followed by 2400 mg/m² IV as a continuous infusion over 46 hr q2Weeks

Combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin, is 400 mg/m² IVP on Day 1, followed by 2400 mg/m² IV as a continuous infusion over 46 hr q2Weeks

Glioblastoma Multiforme (Orphan)

Orphan indication sponsor

  • Ethypharm SA; 194 Bureaux de la Colline - Batiment D; 92213 Saint-Cloud Cedex

Other Indications & Uses

Off-label use for cervical, bladder, hepatic, prostate, endometrial, and head and neck carcinoma

Safety & efficacy not established

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Interactions

Interaction Checker

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              Serious - Use Alternative (10)

              • adenovirus types 4 and 7 live, oral

                fluorouracil decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • deferiprone

                deferiprone, fluorouracil. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • erdafitinib

                fluorouracil will increase the level or effect of erdafitinib by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. If unable to avoid coadministration with strong CYP2C9 inhibitors, monitor closely for adverse reactions and consider decreasing dose accordingly. If strong CYP2C9 inhibitor is discontinued, consider increasing erdafitinib dose in the absence of any drug-related toxicities.

              • germanium

                germanium increases toxicity of fluorouracil by unspecified interaction mechanism. Contraindicated. Risk of toxicity, death with combination.

              • influenza virus vaccine quadrivalent, adjuvanted

                fluorouracil decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                fluorouracil decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • palifermin

                palifermin increases toxicity of fluorouracil by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • siponimod

                fluorouracil will increase the level or effect of siponimod by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Coadministration of siponimod with drugs that cause moderate CYP2C9 AND a moderate or strong CYP3A4 inhibition is not recommended. Caution if siponimod coadministered with moderate CYP2C9 inhibitors alone.

              • tinidazole

                tinidazole will increase the level or effect of fluorouracil by decreasing hepatic clearance. Avoid or Use Alternate Drug. If the concomitant use of tinidazole and fluorouracil cannot be avoided, monitor for fluorouracil-associated toxicities.

              • tofacitinib

                fluorouracil, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (40)

              • acalabrutinib

                acalabrutinib, fluorouracil. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • antithrombin III

                fluorouracil increases effects of antithrombin III by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              • argatroban

                fluorouracil increases effects of argatroban by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              • belatacept

                belatacept and fluorouracil both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • bivalirudin

                fluorouracil increases effects of bivalirudin by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              • cholera vaccine

                fluorouracil decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • dabigatran

                fluorouracil increases effects of dabigatran by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              • dalteparin

                fluorouracil increases effects of dalteparin by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              • dengue vaccine

                fluorouracil decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                fluorouracil, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • diclofenac

                fluorouracil will increase the level or effect of diclofenac by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Do not exceed diclofenac dose of 50 mg BID

              • dronabinol

                fluorouracil will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.

              • eluxadoline

                fluorouracil increases levels of eluxadoline by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. As a precautionary measure due to incomplete information on the metabolism of eluxadoline, use caution when coadministered with strong CYP2C9/10 inhibitors.

              • enoxaparin

                fluorouracil increases effects of enoxaparin by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              • ethotoin

                fluorouracil increases levels of ethotoin by unknown mechanism. Use Caution/Monitor. Based on case reports.

              • eucalyptus

                eucalyptus increases levels of fluorouracil by Other (see comment). Use Caution/Monitor. Comment: Applies to topical preparations only. Mechanism: enhanced transdermal absorption.

              • fingolimod

                fluorouracil increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • fondaparinux

                fluorouracil increases effects of fondaparinux by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              • fosphenytoin

                fluorouracil increases levels of fosphenytoin by unknown mechanism. Use Caution/Monitor. Based on case reports.

              • glyburide

                fluorouracil increases levels of glyburide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Strong CYP2C9 inhibitors may decrease glyburide metabolism.

              • heparin

                fluorouracil increases effects of heparin by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              • hydroxyurea

                fluorouracil, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • influenza A (H5N1) vaccine

                fluorouracil decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                fluorouracil decreases effects of influenza virus vaccine (H5N1), adjuvanted by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • lacosamide

                fluorouracil increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.

              • lesinurad

                fluorouracil will increase the level or effect of lesinurad by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • leucovorin

                leucovorin increases toxicity of fluorouracil by pharmacodynamic synergism. Use Caution/Monitor.

              • meningococcal group B vaccine

                fluorouracil decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • metronidazole

                metronidazole increases toxicity of fluorouracil by decreasing elimination. Use Caution/Monitor.

              • ofatumumab SC

                ofatumumab SC, fluorouracil. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                fluorouracil and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • ospemifene

                fluorouracil increases levels of ospemifene by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • oxaliplatin

                oxaliplatin will increase the level or effect of fluorouracil by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

              • phenytoin

                fluorouracil increases levels of phenytoin by unknown mechanism. Use Caution/Monitor. Based on case reports.

              • siponimod

                siponimod and fluorouracil both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                fluorouracil decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • terbinafine

                fluorouracil will increase the level or effect of terbinafine by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.

              • trastuzumab

                trastuzumab, fluorouracil. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, fluorouracil. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • warfarin

                fluorouracil increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

              Minor (4)

              • maitake

                maitake increases effects of fluorouracil by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).

              • taurine

                fluorouracil decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.

              • vitamin A

                vitamin A, fluorouracil. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

              • vitamin E

                vitamin E, fluorouracil. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

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              Adverse Effects

              1-10%

              Loss of appetite

              Headache

              Nausea

              Vomiting

              Diarrhea

              Mucositis

              Myelosuppression

              Alopecia

              Photosensitivity

              Hand-foot syndrome

              Maculopapular eruption (pruritic)

              Frequency Not Defined

              Angina

              Coronary arteriosclerosis

              Thrombophlebitis

              Darkening of veins

              Gastrointestinal ulcer

              Increased alkaline phosphatase

              Increased LFTs

              Hyperbilirubinemia

              Hypercholesterolemia (increased LDH)

              Anaphylaxis

              Nystagmus

              Ophthalmic findings

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              Warnings

              Black Box Warnings

              The drug should be administered under the supervision of an experienced cancer chemotherapy physician because of the possibility of severe toxic reactions

              Patient should be hospitalized for initiation of the therapy because of the risk for severe toxic reactions

              Contraindications

              None

              Cautions

              Discontinue in case of stomatitis, esophagopharyngitis, leukopenia, thrombocytopenia, intractable vomiting, GI bleeding, hemorrhage

              Severe diarrhea may occur; withhold fluorouracil for Grade 3 or 4 diarrhea until resolved or decreased in intensity to Grade 1, then resume fluorouracil at a reduced dose; administer fluids, electrolyte replacement, or antidiarrheal treatments as necessary

              Therapy can cause neurologic toxicity, including acute cerebellar syndrome and other neurologic events, based on postmarketing reports; neurologic symptoms included confusion, disorientation, ataxia, or visual disturbances; withhold fluorouracil for neurologic toxicity; there are insufficient data on risks of resumption of fluorouracil in patients with neurologic toxicity that has resolved

              Treatment can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure; reported risk factors for cardiotoxicity are administration by continuous infusion rather than intravenous bolus and presence of coronary artery disease; withhold fluorouracil for cardiotoxicity; risks of resumption of fluorouracil in patients with cardiotoxicity that has resolved not established

              Mucositis, stomatitis or esophagopharyngitis, which may lead to mucosal sloughing or ulceration, can occur with fluorouracil; the incidence is reported to be higher with administration by intravenous bolus compared with administration by continuous infusion; withhold administration for Grade 3 or 4 mucositis; resume fluorouracil at a reduced dose once mucositis has resolved or decreased in severity to Grade 1

              Clinically significant elevations in coagulation parameters have been reported during concomitant use of warfarin and fluorouracil; closely monitor patients receiving concomitant coumarin-derivative anticoagulants such as warfarin for INR or prothrombin time in order to adjust anticoagulant dose accordingly

              Myelosuppression

              • Treatment can cause severe and fatal myelosuppression which may include neutropenia, thrombocytopenia, and anemia
              • The nadir in neutrophil counts commonly occurs between 9 and 14 days after drug administration; obtain complete blood counts prior to each treatment cycle, weekly if administered on a weekly or similar schedule, and as needed
              • Withhold fluorouracil until Grade 4 myelosuppression resolves; resume fluorouracil at a reduced dose when myelosuppression has resolved or improved to Grade 1 in severity

              Palmar-plantar erythrodysesthesia

              • Therapy can cause palmar-plantar erythrodysesthesia, also known as hand-foot syndrome (HFS)
              • Symptoms of HFS include a tingling sensation, pain, swelling, and erythema with tenderness, and desquamation; HFS occurs more commonly when fluorouracil is administered as a continuous infusion than when administered as a bolus injection, and has been reported to occur more frequently in patients with previous exposure to chemotherapy
              • HFS is generally observed after 8 to 9 weeks of drug administration but may occur earlier; institute supportive measures for symptomatic relief of HFS; withhold administration for Grade 2 or 3 HFS; resume fluorouracil at a reduced dose when HFS is completely resolved or decreased in severity to Grade 1

              Patients with low or absent dipyrimidine dehydrogenase activity

              • Based on postmarketing reports, patients with certain homozygous or certain compound heterozygous mutations in the DPD gene that result in complete or near complete absence of DPD activity are at increased risk for acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by fluorouracil (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity)
              • Patients with partial DPD activity may also have increased risk of severe, life-threatening, or fatal adverse reactions caused by fluorouracil
              • Withhold or permanently discontinue fluorouracil based on clinical assessment of the onset, duration and severity of the observed toxicities in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity
              • No fluorouracil dose has been proven safe for patients with complete absence of DPD activity; there is insufficient data to recommend a specific dose in patients with partial DPD activity as measured by any specific test

              Hyperammonemic encephalopathy

              • Drug can cause hyperammonemic encephalopathy in absence of liver disease or other identifiable cause, based on postmarketing reports
              • Signs or symptoms of hyperammonemic encephalopathy reported to start within 72 hours after initiation of fluorouracil infusion; these included altered mental status, confusion, disorientation, coma, or ataxia, in the presence of concomitant elevated serum ammonia level
              • Withhold fluorouracil for hyperammonemic encephalopathy and initiate ammonia-lowering therapy; the risks of resumption of fluorouracil in patients with hyperammonemic encephalopathy that has resolved have not been established
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              Pregnancy & Lactation

              Pregnancy

              There are no adequate and well-controlled studies with fluorouracil in pregnant women; based on its mechanism of action, the drug can cause fetal harm when administered to a pregnant woman

              If this drug is used during pregnancy, or patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus

              Contraception

              • Females: Based on mechanism of action, drug can cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment with fluorouracil and for up to 3 months following cessation of therapy
              • Males: Fluorouracil may damage spermatozoa; advise males with female partners of reproductive potential to use effective contraception during and for 3 months following cessation of therapy

              Infertility

              • Females: Advise females of reproductive potential that, based on animal data, fertility may be impaired while receiving fluorouracil
              • Males: Advise males of reproductive potential that, based on animal data, fertility may be impaired while receiving fluorouracil

              Animal data

              • Administration to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity; malformations included cleft palate and skeletal defects
              • In monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion

              Lactation

              Not known whether fluorouracil or its metabolites are present in human milk; because many drugs are present in human milk and because of potential for serious adverse reactions in nursing infants from fluorouracil, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account importance of drug to the mother

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Inhibits DNA synthesis during S phase by inhibition of thymidylate synthetase

              Pharmacokinetics

              Half-Life: 16 min

              Onset: 2-7 d, but may take up to 12 wk

              Duration: 24 hr

              Metabolism: liver

              Metabolites: urea, fluorouracil, dihydrofluorouracil, expired CO2 metabolite

              Excretion: urine

              Pharmacogenomics

              Dihydropyrimidine dehydrogenase (DPD), an enzyme encoded by the DPYD gene, is the rate-limiting step in pyrimidine catabolism and deactivates >80% of 5FU standard doses and the 5FU prodrug capecitabine

              Contraindicated in patients with DPD deficiency; causes severe toxicity with conventional doses (ie, grade III/IV toxicity and potentially fatal neutropenia, mucositis, and diarrhea)

              Because true DPD deficiency is rare and because the clinical implications of partial deficiency are still unclear, screening for mutations prior to initiating therapy is not warranted

              Genetic testing laboratories

              • The following companies currently offer testing for DPYD*2A mutations
              • EntroGen (http://www.entrogen.com)
              • Myriad (http://www.myriadtests.com)
              • LabCorp (http://www.labcorp.com)
              • Molecular Diagnostics Laboratories (http://www.mdl-labs.com)
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              Administration

              IV Incompatibilities

              Additive: carboplatin, cisplatin, cytarabine, diazepam, doxorubicin, epirubicin, fentanyl, leucovorin, metoclopramide, morphine sulfate

              Syringe: doxorubicin (at high conc of doxo & 5FU, compatible at lower conc), droperidol, epirubicin

              Y-site: aldesleukin, amphotericin B cholesteryl SO4, droperidol, filgrastim, ondansetron(?), topotecan, vinorelbine

              IV Compatibilities

              Solution: compatible w/ most common solvents

              Additive: bleomycin, cyclophosphamide, cyclophosphamide/methotrexate, etoposide, floxuridine, hydromorphone, ifosfamide, methotrexate, mitoxantrone, vincristine

              Syringe: bleomycin, cisplatin, cyclophosphamide, furosemide, heparin, leucovorin, methotrexate, metoclopramide, mitomycin, vinblastine, vincristine

              Y-site: (partial list) allopurinol, furosemide, granisetron, heparin, hydrocortisone-Na-succinate, leucovorin, linezolid, metoclopramide, piperacillin/tazobactam, KCl, propofol, vit B/C

              IV Preparation

              IV Push: dose/syringe (concentration: 50 mg/mL); max syringe size for IVP is 30 mL syringe and syringe should be <75% full

              Continuous IV Infusion/IVPB: dose/50-1000 mL D5W or NS; syringe and solution are stable for 72 hr at 4 to 25°C

              IV Administration

              Direct IV push injection (50 mg/mL solution needs no further dilution) or by IV infusion

              Toxicity may be reduced by giving the drug as a constant infusion

              Bolus doses may be administered by slow IVP or IVPB

              Warm to body temperature before using

              Continuous IV infusion may be administered in D5W or NS

              Solution should be protected from direct sunlight

              5-FU may also be administered intra-arterially or intra-hepatically

              Use plastic IV containers for continuous infusions (stable in plastic IV bags than in glass bottles)

              Storage

              Store intact vials at room temp & protect from light

              Slight discoloration does not usually denote decomposition

              Don't use cloudy solutions

              • If crystals form, redissolve by warming

              Don't refrigerate

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Adrucil intravenous
              -
              5 gram/100 mL vial
              Adrucil intravenous
              -
              500 mg/10 mL vial
              Adrucil intravenous
              -
              2.5 gram/50 mL vial
              fluorouracil topical
              -
              0.5 % cream
              fluorouracil topical
              -
              5 % cream
              fluorouracil topical
              -
              5 % cream
              fluorouracil topical
              -
              5 % solution
              fluorouracil topical
              -
              2 % solution
              fluorouracil topical
              -
              5 % cream
              fluorouracil topical
              -
              5 % cream
              Carac topical
              -
              0.5 % cream
              Fluoroplex topical
              -
              1 % cream
              Efudex topical
              -
              5 % cream
              fluorouracil intravenous
              -
              500 mg/10 mL vial
              fluorouracil intravenous
              -
              1 gram/20 mL vial
              fluorouracil intravenous
              -
              1 gram/20 mL vial
              fluorouracil intravenous
              -
              5 gram/100 mL vial
              fluorouracil intravenous
              -
              500 mg/10 mL vial
              fluorouracil intravenous
              -
              500 mg/10 mL vial
              fluorouracil intravenous
              -
              5 gram/100 mL vial
              fluorouracil intravenous
              -
              2.5 gram/50 mL vial
              fluorouracil intravenous
              -
              5 gram/100 mL vial
              fluorouracil intravenous
              -
              2.5 gram/50 mL vial
              fluorouracil intravenous
              -
              2.5 gram/50 mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Select a drug:
              Patient Education
              fluorouracil topical

              FLUOROURACIL - TOPICAL

              (flewr-oh-YOUR-uh-sill)

              COMMON BRAND NAME(S): Efudex, Fluoroplex

              USES: This medication is used on the skin to treat pre-cancerous and cancerous skin growths. Fluorouracil belongs to a class of medications known as anti-metabolites. It works by blocking the growth of abnormal cells that cause the skin condition.

              HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Use this medication as directed by your doctor. Before you apply this medication to the skin, clean the affected area and dry well. Wait 10 minutes, then apply a small amount of medication to the affected skin, using just enough to cover the area with a thin film. Wash your hands immediately after applying this medication, even if you have used gloves.The treated area may become unsightly during treatment and in some cases for several weeks after treatment. Do not cover the area with tight dressings or plastic bandages. Check with your doctor whether you may cover the treated area loosely with gauze.Avoid applying this medication in or around the eyes or eyelids. Also, do not apply this medication inside the nose or mouth. If you do get the medication in these areas, rinse with plenty of water.Use this medication exactly as prescribed. Do not stop using this medication without consulting your doctor. Do not increase your dose or use it more often than directed. Your condition will not clear faster, but side effects will be increased.If your condition worsens or does not improve, consult your doctor or pharmacist promptly.

              SIDE EFFECTS: Skin irritation, burning, redness, dryness, pain, swelling, tenderness, or changes in skin color may occur at the site of application. Eye irritation (e.g., stinging, watering), trouble sleeping, irritability, temporary hair loss, or abnormal taste in the mouth may also occur.If any of these effects persist or worsen, contact your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these rare but very serious side effects occur: stomach/abdominal pain, bloody diarrhea, vomiting, signs of infection (e.g., fever, chills, persistent sore throat), easy bruising/bleeding, mouth sores.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using fluorouracil, tell your doctor or pharmacist if you are allergic to it; or to flucytosine; or to capecitabine; or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain enzyme deficiency (dihydropyrimidine dehydrogenase - DPD).Before using this medication, tell your doctor or pharmacist your medical history, especially of: red/irritated/infected/open sores on skin.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. After using fluorouracil cream, wait 2 hours before applying sunscreen or moisturizer to the treated area. Do not use other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor to do so. Tell your doctor right away if you get sunburned or have skin blisters/redness.This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor right away. Consult your doctor for more details and to discuss reliable forms of birth control.It is not known if this medication passes into breast milk. Due to the potential risk to a nursing infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

              OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.This medication must be used under close medical supervision. Be sure to keep all your medical appointments so your doctor can monitor your progress or any side effects.Discard any unused medication when the treatment is finished. Do not use it for any other skin conditions unless directed to do so by your doctor.There are different brands and forms of this medication available. Not all have identical effects. Do not change brands or forms without consulting your doctor or pharmacist.

              MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.