fludarabine (Rx)Brand and Other Names:Fludara, Oforta

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 25mg/mL

powder for injection

  • 50mg

tablet

  • 10mg
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B-Cell Chronic Lymphocytic Leukemia

25 mg/sq.meter IV infusion over 30 minutes qD x5 days (up to 30 mg/sq.meter) 

40 mg/sq.meter PO x5 days

Repeat q28Days

Renal impairment

  • CrCl 30-70 mL/min: reduce by 20%
  • CrCl <30 mL/min: IV not recommended; PO reduce 50%

Non-Hodgkin Lymphoma (Orphan)

Treatment and management of non-Hodgkin lymphoma

Orphan indication sponsor

  • Berlex Laboratories, Inc; 15049 San Pablo Avenue, P.O. Box 4099; Richmond, CA 94804-0099

Other Information

Monitor: CBC, chemistries, pulmonary function

Other Indications & Uses

Off-label: hairy cell leukemia, NHL, prolymphocytic leukemia, mycosis fungoides, Hodgkin's disease

Safety and efficacy not established

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Interactions

Interaction Checker

fludarabine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Fever (69%)

            Objective weakness (65%)

            Anemia (60%)

            Neutropenia (60%)

            Thrombocytopenia (55%)

            Leukopenia (partly therapeutic)

            Infection (44%-not necessarily drug-induced)

            Cough (44%)

            Pain (44%)

            Fatigue (38%)

            N/V (36%)

            Anorexia (34%)

            Malaise (22%)

            Dyspnea (22%)

            Pneumonia (9-22%)

            Edema (19%)

            Myalgia (16%)

            URI (16%)

            UTI (15%)

            Rash (15%)

            Diarrhea (15%)

            Visual disturbances (15%)

            Diaphoresis (13%)

            GI bleeding (13%)

            Paresthesia (12%)

            1-10% (selected)

            Abdominal pain (10%)

            Back pain (9%)

            Headache (9%)

            Pharyngitis (9%)

            Stomatitis (9%)

            Flu like syndrome (5-9%)

            Malaise (6%)

            Angina (6%)

            Hearing Loss (2-6%)

            Peripheral edema (7%)

            Alopecia (3%)

            Constipation (1-3%)

            Arrhythmia (3%)

            DVT (1%)

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            Bone marrow suppression may occur. Fludarabine has been associated with severe neurologic effects, including blindness, coma when high doses were used in patients with acute leukemia. Agitation, coma, confusion, and seizures have been reported in patients treated at recommended doses for the treatment of chronic lymphocytic leukemia

            If one or more cycles of treatment with fludarabine administered, autoimmune phenomena including acquired hemophilia, autoimmune thrombocytopenia/thrombocytopenic purpura, Evan syndrome, and hemolytic anemia may occur. Monitor patients closely for hemolysis

            Fludarabine in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia is not recommended due to a high incidence of fatal pulmonary toxicity

            Contraindications

            Hypersensitivity

            Concomitant pentostatin: risk of fatal pulmonary toxicity

            IV: severe renal impairment

            Cautions

            Bone marrow depression, renal impairment, elderly

            Allopurinol and hydration recommended for patients newly diagnosed with CLL or those at risk of tumor lysis syndrome

            Very high doses (and rarely, normal doses) have caused irreversible or fatal neurotoxicity manifesting after 21-60 days

            Risk of potentially fatal autoimmune hemolytic anemia

            Avoid pregnancy

            No efficacy in children

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk, 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

            Peak plasma time: 2 hr

            Vd: 96-98 L/sq.meter

            Protein bound: 19-29%

            Metabolites: 2-fluoro-ara-ATP

            Clearance: 8.9 L/hr/sq.meter

            Excretion: urine

            Mechanism of Action

            Fluorinated purine analog, inhibits DNA polymerase alpha

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            Administration

            IV Incompatibilities

            Y-site: acyclovir, amphotericin B, chlorpromazine, daunorubicin, ganciclovir, hydroxyzine, prochlorperazine

            IV Compatibilities

            Y-site (partial list): allopurinol, ampicillin, bleomycin, carboplatin, most cephalosporins, cisplatin, dactinomycin, doxorubicin, fluconazole, hydromorphone, imipenem-cilastatin, lorazepam, MgSO4, metoclopramide, morphine SO4, KCl, NaHCO3, TMP-SMX, vancomycin, zidovudine

            IV Preparation

            Reconstitute powder for inj with 2 mL SWI to result in a concentration of 25 mg/mL

            Standard IV dilution: dose/100 mL D5W or NS

            IV Administration

            IV infusion over 30 min recommended by Mfr; has been given as continuous infusion or by rapid injection but risk of toxicity may be higher

            Storage

            Store intact vials under refrigeration

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            Images

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            Formulary

            FormularyPatient Discounts

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            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.
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            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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