Parenteral Manual

Fludarabine (NON-FORMULARY)

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Alternate Name(s): 
FLUDARA, F-araAMP
Classification: 
Antimetabolite antineoplastic -CYTOTOXIC
Original Date: 
August 2005
Revised Date: 
December 2020
Indications: 
  • Relapsed or refractory acute leukemia

THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.

Reconstitution and Stability: 
  • Refrigerate vials
  • Available as a 25 mg/mL single use, preservative-free solution in a 2 mL vial
  • Infusion solutions, diluted to 1 mg/mL or less, are stable for 24 hours at room temperature or 48 hours under refrigeration
Compatibility: 

- Solutions Compatible: D5W, 0.9% NaCl

- Additives/Above Cassette Compatible: no information

- Y-site Compatible: allopurinol, cytarabine, diphenhydramine, dexamethasone, fluconazole, gentamicin, heparin, hydrocortisone, hydromorphone, magnesium, mannitol, mesna, methylprednisolone, metoclopramide, morphine, ondansetron, potassium chloride, ranitidine, sodium bicarbonate

- Incompatible: acyclovir, amphotericin, chlorpromazine, daunorubicin and ganciclovir

 

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Push NO
IV Intermittant Infusion YES
Usual dilution: dilute in 25-100 mL D5W or NS
Infusion time: 30-60 minutes
IV Continuous Infusion YES,
Usual dilution: dilute in 250-500 mL D5W or NS over 24 hours

 

 

Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

Maximum of 4-6 courses.

Acute leukemia:

  • Loading dose: 10 mg/m2/dose IV followed by continuous infusion
  • Continuous IV infusion: 30.5 mg/m2/24 hours x 2-5 days
  • 25 - 30 mg/m IV daily x 5 days

Solid tumors:

  • 9 mg/m2 bolus, followed by 27 mg/m2/day continuously x 5 days

** Dosage may differ according to protocol

Dose adjustment in renal impairment:

  • CrCl  30-70 mL/minute:  Decrease dose by 50%
  • CrCl  < 30 mL/minute:  Not recommended
Potential hazards of parenteral administration: 
  • The dose-limiting toxicity of fludarabine is myelosuppression.  The nadir is approximately 8 days for WBCs and 15 days for platelets.                                 
  • Severe, potentially irreversible or fatal neurologic effects have been seen with high doses of fludarabine (77 mg/m2 daily for 5-7 days), occurring 21-60 days after treatment.  This toxicity manifests as visual deficits, dysarthria (difficulty with speech), paresthesia, weakness and seizures, apparently due to progressive demyelination in the CNS.  These effects are rare at lower doses.
  • Adverse neurological effects that may occur at all dosages include weakness, pain, malaise, fatigue, paresthesia, visual disturbances, hearing disturbances, sleep disorder or headaches.
  • Adverse respiratory effects have occurred including:  pneumonia, cough, dyspnea, upper respiratory infections, pharyngitis, interstitial pneumonitis (these effects are rare).
  • Hyperuricemia, hyperkalemia, hypocalcemia (Tumor Lysis Syndrome): for first course in patients with large tumor burden.
  • Autoimmune hemolytic anemia (rare)
  • Non-vesicant
  • Nausea and/or vomiting is generally mild.  Anorexia, diarrhea, GI bleeding and stomatitis may occur
  • Transiently increased liver function tests (mild).
  • Fever/chills have been reported in up to 69% of patients
  • Rash, fatigue

- Treatment for unusual side effects available through the study chair identified on the front page of the protocol and/or pharmacy

Notes: 
  • Give fludarabine before cytarabine (enhancement of cytarabine's activity).  If cytarabine is given first the activity of fludarabine is inhibited.
  • Do not give fludarabine and pentostatin concurrently, severe pulmonary toxicity may develop
  • Use with caution in patients with pre-existing neurologic problems
References: 
  1. Fludarabine Product Monograph. Accord Healthcare Inc. Version March 11, 2015. Accessed 20Nov2020.
  2. Cancer Drug Manual. BC Cancer. Accessed 20Nov2020.

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