fludarabine

Contraindicated in:

Hypersensitivity to fludarabine, mannitol, or sodium hydroxide;
Patients taking pentostatin;
OB: 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.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema

Derm: rashes

EENT: hearing loss, visual disturbances

Endo: gonadal suppression

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

GU: dysuria, hematuria, urinary tract infection

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

MS: myalgia

Neuro: fatigue, agitation, coma, confusion, headache, malaise, NEUROTOXICITY, peripheral neuropathy, weakness

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

Misc: fever, tumor lysis syndrome

Interactions ⬆ ⬇

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).

Availability ⬆ ⬇

(Generic available)

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

Route/Dosage ⬆ ⬇

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.

Renal Impairment

PO IV (Adults ): CCr 30–70 mL/min: ↓dose by 20%.

Renal Impairment

PO (Adults ): CCr <30 mL/min: ↓dose by 50%.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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

Therapeutic effects:

Death of rapidly replicating cells, particularly malignant ones.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites

Pharmacokinetics ⬆ ⬇

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).

Time/Action Profile ⬆ ⬇

(effects on blood counts)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	13–16 days	unknown
IV	7 wk‡	13–16 days	unknown

‡Median time to response.

Patient/Family Teaching ⬆ ⬇

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.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

24201- Leucadia Pharmaceuticals
- 24201-237- fludarabine phosphate
  - 24201-237-01- 1 VIAL in 1 CARTON (24201-237-01) > 2 mL in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-242- Fludarabine Phosphate
  - 25021-242-02- 1 VIAL in 1 CARTON (25021-242-02) > 2 mL in 1 VIAL

45963- Actavis Pharma, Inc.
- 45963-609- Fludarabine phosphate
  - 45963-609-55- 1 VIAL, GLASS in 1 CARTON (45963-609-55) > 2 mL in 1 VIAL, GLASS

45963- Actavis Pharma, Inc.
- 45963-621- Fludarabine phosphate
  - 45963-621-51- 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-621-51) > 2 mL in 1 VIAL, SINGLE-DOSE

61703- Hospira, Inc.
- 61703-344- Fludarabine Phosphate
  - 61703-344-18- 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-344-18) > 2 mL in 1 VIAL, SINGLE-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-192- Fludarabine
  - 63323-192-02- 1 VIAL in 1 BOX (63323-192-02) > 2 mL in 1 VIAL

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Indications ⬇

Contraind./Precautions ⬆ ⬇