Classes
DEA Class; Rx
Common Brand Names; Fludara, Oforta
- Antineoplastics, Antimetabolite
Description
Purine nucleoside antineoplastic agent
Used for the treatment of adult patients with B-cell chronic lymphocytic leukemia who have not responded to or whose disease has progressed during treatment with at least 1 standard alkylating agent-containing regimen
Life-threatening or fatal autoimmune reactions have been reported; monitor for hemolysis
Indications
Indicated for the treatment of chronic lymphocytic leukemia (CLL).
Contraindications
Hypersensitivity
Concomitant pentostatin: risk of fatal pulmonary toxicity
IV: severe renal impairment
Adverse Effects
- Fever (69%)
- Objective weakness (65%)
- Anemia (60%)
- Neutropenia (60%)
- Thrombocytopenia (55%)
- Leukopenia (partly therapeutic)
- Infection (44%-not necessarily drug-induced)
- Cough (44%)
- Pain (44%)
- Fatigue (38%)
- N/V (36%)
- Anorexia (34%)
- Malaise (22%)
- Dyspnea (22%)
- Pneumonia (9-22%)
- Edema (19%)
- Myalgia (16%)
- URI (16%)
- UTI (15%)
- Rash (15%)
- Diarrhea (15%)
- Visual disturbances (15%)
- Diaphoresis (13%)
- GI bleeding (13%)
- Paresthesia (12%)
Warnings
Bone marrow depression, renal impairment, elderly
Allopurinol and hydration recommended for patients newly diagnosed with CLL or those at risk of tumor lysis syndrome
Very high doses (and rarely, normal doses) have caused irreversible or fatal neurotoxicity manifesting after 21-60 days
Risk of potentially fatal autoimmune hemolytic anemia
Avoid pregnancy
No efficacy in children
Pregnancy and Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, do not nurse
Maximum Dosage
25 mg/m2 IV daily for 5 days repeated every 28 days; 30 mg/m2 IV daily for 5 days has been studied for off-label uses.
25 mg/m2 IV daily for 5 days repeated every 28 days; 30 mg/m2 IV daily for 5 days has been studied for off-label uses.
Safety and efficacy not established.
Safety and efficacy not established.
Safety and efficacy not established.
How supplied
Fludarabine phosphate
injectable solution
- 25mg/mL
powder for injection
- 50mg
tablet
- 10mg