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Fludarabine

    DEA Class; Rx

    Common Brand Names; Fludara, Oforta

    • Antineoplastics, Antimetabolite

    Purine nucleoside antineoplastic agent
    Used for the treatment of adult patients with B-cell chronic lymphocytic leukemia who have not responded to or whose disease has progressed during treatment with at least 1 standard alkylating agent-containing regimen
    Life-threatening or fatal autoimmune reactions have been reported; monitor for hemolysis

    Indicated for the treatment of chronic lymphocytic leukemia (CLL).

    For the treatment of prolymphocytic leukemia (PLL).
    For the treatment of non-Hodgkin’s lymphoma (NHL).
    For the treatment of acute myelogenous leukemia (AML).
    For use in stem cell transplant preparation.

    Hypersensitivity

    Concomitant pentostatin: risk of fatal pulmonary toxicity

    IV: severe renal impairment

    • 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%)

    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

    Pregnancy Category: D

    Lactation: not known if excreted in breast milk, do not nurse

    Adults

    25 mg/m2 IV daily for 5 days repeated every 28 days; 30 mg/m2 IV daily for 5 days has been studied for off-label uses.

    Geriatric

    25 mg/m2 IV daily for 5 days repeated every 28 days; 30 mg/m2 IV daily for 5 days has been studied for off-label uses.

    Adolescents

    Safety and efficacy not established.

    Children

    Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    Fludarabine phosphate

    injectable solution

    • 25mg/mL

    powder for injection

    • 50mg

    tablet

    • 10mg