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

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