Classifications: antineoplastic; antimetabolite, purine antagonist; immunosuppressant; Therapeutic:antineoplastic; antimetabolite; immunosuppressant
Pregnancy Category: D
50 mg powder for injection; 25 mg/mL solution for injection
Believed to act by inhibiting DNA polymerase alpha, ribonucleotide reductase, and DNA primase, thus inhibiting DNA synthesis
in tumor-sensitive cells.
Fludarabine has cytotoxic effects on lymphocytic leukemia and lymphoma as well as immunosuppressant properties.
Treatment of B-cell chronic lymphocytic leukemia (CLL) in patients who fail to respond to a regimen containing at least one
standard alkylating agent.
Non-Hodgkin's lymphoma; in combination therapy for the treatment of primary resistant or relapsing acute myelogenous leukemia
(AML), acute lymphoblastic leukemia (ALL), and secondary AML; cutaneous T-cell lymphoma; macroglobulinemia; myelodysplastic
syndrome; prolymphocytic leukemia (PLL); stem-cell transplant preparation.
Hypersensitivity to fludarabine; concomitant administration of pentostatin; pregnancy (category D); lactation. Safety and
efficacy in children have not been established.
Renal impairment; patients at risk for tumor lysis syndrome; history of herpes or viral infection.
Route & Dosage
|Treatment of Unresponsive B-cell Chronic Lymphocytic Leukemia
Adult: IV 25 mg/m2 q.d. x 5 d; repeat q28d
Clcr 3070 mL/min/1.73 m2: 20% dose reduction; <30 mL/min/1.73 m2: should not receive fludarabine
PREPARE: IV Infusion: Exercise caution in the preparation and handling of fludarabine. Avoid exposure by inhalation or direct contact with skin
or mucous membranes. Reconstitute each 50 mg vial by adding 2 mL of sterile water for injection to yield 25 mg/mL. The solution
should dissolve within 15 s and have a pH of 7.2-8.2. Further dilute in 100125 mL of D5W or NS. Administer within 8
h of reconstitution.
ADMINISTER: IV Infusion: Give over 30 min.
INCOMPATIBILITIES Y-site: Acyclovir, amphotericin B, chlorpromazine, daunorubicin, ganciclovir, hydroxyzine, prochlorperazine.
- Store unreconstituted vials at 2°8° C (36°46° F). Discard any unused reconstituted product.
Adverse Effects (≥1%)Body as a Whole: Fever, chills, fatigue, infection, pain,
malaise, diaphoresis, anaphylaxis, hyperglycemia, dehydration. CNS: Weakness,
paresthesia. CV: Edema
. GI: Nausea, vomiting, diarrhea, anorexia, stomatitis,
GI bleeding, esophagitis, mucositis. Hematologic: Neutropenia, thrombocytopenia, hemolytic anemia
Myalgia. Respiratory: Cough, pneumonia, dyspnea, sinusitis
, pharyngitis, upper respiratory tract infection
. Skin: Rash,
pruritus. Special Senses:
Visual disturbance, hearing loss. Urogenital:
Dysuria, urinary infection, hematuria.
Use with pentostatin
increases risk of severe pulmonary toxicity. Do not give live vaccines
due to decreased immune response.
Rapid conversion to active metabolite (2-fluoro-ara-A). Elimination:
Assessment & Drug Effects
- Review creatinine clearance values prior to drug administration. A 20% dose reduction is recommended for Clcr 3070 mL/min. Withhold drug and notify physician if Clcr <30 mL/min.
- Monitor for and report S&S of hemolysis, infection, tumor lysis syndrome (e.g., flank pain, hematuria), peripheral neuropathy,
or respiratory distress.
- Lab tests: Baseline CBC with differential and platelet count, repeat prior to each treatment cycle, and more often as indicated;
periodic serum electrolytes, serum uric acid, and renal function tests.
Patient & Family Education
- Report any of the following to a health care provider: fever, chills, cough, sore throat, or other signs of infection; pain
or difficulty passing urine; signs of bleeding such as easy bruising, black, tarry stools, nosebleeds; signs of anemia such
as excessive weakness, lightheadedness, or confusion; difficulty breathing or shortness of breath; decreased vision; mouth
sores or skin rash.
- Avoid activities that could cause physical injury and predispose to severe bleeding.
- Women of childbearing age should avoid becoming pregnant while receiving fludarabine.