• B-cell chronic lymphocytic leukemia unresponsive to standard therapy.

Unlabeled Uses:

• Non-Hodgkin's lymphoma.

Contraindicated in:

• Hypersensitivity to fludarabine, mannitol, or sodium hydroxide
• Patients taking pentostatin
• OB: Lactation: Pregnancy or lactation
• Severe renal impairment (CCr <30 mL/min) (for intravenous).

Use Cautiously in:

• Moderate renal impairment (↓ dose if CCr <70 mL/min)
• OB: Patients with childbearing potential
• Bone marrow depression
• Pedi: Safety not established.

CNS: NEUROTOXICITY, fatigue, agitation, coma, confusion, headache, malaise, weakness.

EENT: hearing loss, visual disturbances.

Resp: PULMONARY HYPERSENSITIVITY, cough, pneumonia, dyspnea, sinusitis.

CV: edema.

GI: GI BLEEDING, diarrhea, nausea, anorexia, esophagitis, mucositis, stomatitis, vomiting.

GU: dysuria, hematuria, urinary tract infection.

Derm: rashes.

Endo: gonadal suppression.

Hemat: PANCYTOPENIA, anemia, leukopenia, thrombocytopenia, hemolytic anemia.

MS: myalgia.

Neuro: peripheral neuropathy.
Misc: fever, tumor lysis syndrome.

Drug-Drug:

• ↑bone marrow suppression with other antineoplastics or radiation therapy.
• Concomitant use with pentostatin↑ risk of potentially fatal pulmonary toxicity (concurrent use not recommended).

(Generic available)

• Tablets: 10 mg;
• Powder for injection: 50 mg/vial;
• Solution for injection: 25 mg/mL;

• PO (Adults): 40 mg/m² daily for 5 days; repeat course every 28 days.
• IV (Adults): 25 mg/m² daily for 5 days; repeat course every 28 days.

Fludara, Oforta

• Converted intracellularly to an active phosphorylated metabolite that inhibits DNA synthesis.

• Death of rapidly replicating cells, particularly malignant ones.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites

Absorption: Bioavailability of active metabolite, 2–fluoro-ara-A, is 50–65%.

Distribution: Extensively distributed.

Metabolism/Excretion: Following administration, rapidly converted to an active metabolite (2–fluoro-ara-A), which, when phosphorylated intracellularly, exerts antineoplastic activity; 40% of initial active metabolite excreted unchanged by the kidneys.

Half-life: 20 hr (for initial active metabolite).

(effects on blood counts)

†Median time to response.

• Instruct patient to take fludarabine as directed. Avoid handling tablets; wash hands with soap and water if touching tablet or powder from tablets. Notify health care professional if a dose is missed.
• Caution patient to avoid crowds and persons with known infections. Health care professional should be informed immediately if symptoms of infection (chills, cough, or burning pain on urination) occur.
• Instruct patient to report unusual bleeding. Advise patient of thrombocytopenia precautions (use soft toothbrush and electric razor; avoid contact sports and other situations in which injury might occur). Do not drink alcoholic beverages or take medication containing aspirin or NSAIDs; may precipitate gastric bleeding.
• Instruct patient to inspect oral mucosa for redness and ulceration. If mouth sores occur, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Consult health care professional if pain interferes with eating. Stomatitis pain treatment may require opioid analgesics.
• Advise patient that this medication may have teratogenic effects. Contraception should be used during therapy and for at least 6 mo after therapy is concluded.
• Emphasize the need for periodic lab tests to monitor for side effects.

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