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fluorouracil (Rx)Brand and Other Names:Adrucil

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50mg/mL
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Cancers of Colon, Breast, Ovary, Liver, Pancreas, Rectum, Stomach

Various protocols exist

500 mg/sq.meter IV on Days 1-5, OR 

450-600 mg/sq.meter IV weekly, OR

200-400 mg/sq.meter IV continuous infusion qD

Not to exceed 800 mg/day

Glioblastoma Multiforme (Orphan)

Orphan indication sponsor

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

Advanced Colorectal Carcinoma (Orphan)

Use in combination with recombinant interferon alpha-2a

Orphan indication sponsor

  • Hoffmann-La Roche, Inc; 340 Kingsland Street; Nutley, NJ 07110-1199

Esophageal Carcinoma (Orphan)

Use in combination with recombinant interferon alpha-2a

Orphan indication sponsor

  • Hoffmann-La Roche, Inc; 340 Kingsland Street; Nutley, NJ 07110-1199

Other Information

May use leucovorin concomitantly

Monitor: CBC

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

fluorouracil and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

            Hypersensitivity

            Poor nutritional status

            Myelosuppression

            Serious infection

            Recent serious surgery

            Dihydropyrimidine Dehydrogenase (DPD) deficiency

            Cautions

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

            Prior alkylating agent use, CAD, hepatic/renal impairment

            Avoid pregnancy

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excretion in milk unknown; do not nurse

            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

            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)

            Mechanism of Action

            Inhibits DNA synthesis during S phase by inhibition of thymidylate synthetase

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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

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            Formulary

            FormularyPatient Discounts

            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.
            Add or Remove Plans
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            Select a box to add or remove a plan.

            Select a class to view formulary status for similar drugs

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