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Fludarabine

Oral
Intravenous
Class
Antimetabolites
Subclass
Purine analogs
Substance name
Fludarabine phosphate
Common formulations
Film-coated tablet
Indications for use
Labeled indications
Adults
•
Treatment of B-cell chronic lymphocytic leukemia
Safety risks
Boxed warnings
Acute lung injury
•
Use extreme caution with chronic lymphocytic leukemia and received fludarabine in combination with pentostatin.
Chemotherapy-induced bone marrow suppression
•
Use extreme caution with risk factors for anemia, neutropenia, thrombocytopenia, and pancytopenia or myelosuppression.
Tumor lysis syndrome
•
Use extreme caution with large tumor burdens.
Warnings and precautions
Autoimmune disorders
•
Use caution with signs or symptoms of hemolysis.
Reactivation of infections
•
Use caution with a history of opportunistic infection and viral infection (e.g., herpes infection (zoster), Epstein-Barr, and JC viruses).
Seizures
•
Use caution with a history of seizure disorder.
Specific populations
Renal impairment
eGFR 30-70 mL/min/1.73 m²
•
Use with caution. Reduce dose by 25%-50%.
eGFR 10-30 mL/min/1.73 m²
•
Use with caution. Reduce dose by 25%-50%.
eGFR < 10 mL/min/1.73 m²
•
Use with caution. Reduce dose by 50%.
Renal replacement therapy
Continuous renal replacement
•
Dose as in eGFR 10-30 mL/min/1.73 m². Reduce dose by 25%-50%.
Intermittent hemodialysis
•
Dose as in eGFR < 10 mL/min/1.73 m². Reduce dose by 50%.
Peritoneal dialysis
•
Dose as in eGFR < 10 mL/min/1.73 m². Reduce dose by 50%.
Hepatic impairment
Any severity
•
No guidance available. Monitor serum aminotransferases.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans.
Breastfeeding
Little information available on breastfeeding safety.
•
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Anemia, ↓ blood neutrophil count, ↓ platelet count, diaphoresis, gastrointestinal bleeding, chills, cough, diarrhea, dyspnea, fatigue, fever, loss of appetite, myalgia, nausea, paresthesia, skin rash, visual disturbances, vomiting, weakness
Common 1-10%
•
Acute liver failure, AT, alopecia, cerebellar syndrome, cholelithiasis, dehydration, esophagitis, heart failure, ↑ blood glucose, ↑ liver enzymes, ↑ urine protein, low oxygen levels, myocardial infarction, osteoporosis, pharyngitis, phlebitis, pneumonitis, renal failure, angina pectoris, arthralgia, constipation, depression, dysphagia, dysuria, headache, hearing loss, hematuria, hemoptysis, itching, malaise, nosebleed, sinusitis, stomatitis, stroke, thrombosis, tumor lysis syndrome
Unknown frequency
•
Acute respiratory distress syndrome, agitation, coma, ↓ serum calcium, erythema multiforme, hemolytic anemia, hemorrhagic cystitis, ICH, ↑ serum amylase, ↑ serum phosphate, ↑ serum potassium, ↑ serum uric acid, leukoencephalopathy, metabolic acidosis, nephrolithiasis, optic neuritis, pancytopenia, pemphigus vulgaris, pericardial effusion, peripheral neuropathy, pulmonary fibrosis, purpura, confusion, seizure, respiratory depression, Stevens-Johnson syndrome, toxic epidermal necrolysis
Interactions
Drug(s)
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