Fludarabine
Purine Analogues
- Drug class
- Purine Analogues
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 10
Overview
Plain-language summary, compiled from the cited regulatory records
Fludarabine phosphate is a nucleotide metabolic inhibitor [1]. It belongs to the drug class of purine analogues [1].
Fludarabine phosphate injection is approved for treating adult patients with B-cell chronic lymphocytic leukemia (CLL) [1]. This indication is for patients whose disease has progressed or who have not responded to at least one prior treatment regimen containing an alkylating agent [1]. The benefit of fludarabine phosphate in patients who have not previously received treatment or whose disease has not progressed during treatment has not been established [1].
This medication is available under various brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 7 | May 1, 2026 |
| CA Canada | Health Canada | 2 | June 10, 2025 |
| US United States | FDA | 1 | January 31, 2023 |
GBUnited Kingdom· MHRA
7 products
Uses
Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult patients with sufficient bone marrow reserves. First line treatment with Fludara oral should only be initiated in adult patients with advanced disease, Rai stages III/IV (Binet stage C) or Rai stages I/II (Binet stage A/B) where the patient has disease related symptoms or evidence of progressive disease.
How to take
CACanada· Health Canada
2 products
Uses
FLUDARABINE PHOSPHATE FOR INJECTION (fludarabine phosphate) is indicated for: • Second-line treatment in patients with chronic lymphocytic leukemia (CLL) and low- grade non-Hodgkin's lymphoma (Lg-NHL) who have failed other conventional therapies.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Since there are limited data for the use of fludarabine phosphate in elderly persons (> 75 years), caution should be exercised with the administration of FLUDARABINE PHOSPHATE FOR INJECTION in these patients.
The total body clearance of the principal plasma metabolite 2F- ara-A shows a correlation with creatinine clearance, indicating the importance of the renal excretion pathway for the elimination of the compound. Patients with reduced kidn ey function demonstrated an increased total body exposure (area under the curve [AUC] of 2F-ara-A).
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.
Benefit in treatment-naïve or non-refractory CLL patients is not established. 1 Indication Fludarabine Phosphate Injection is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.
The safety and effectiveness of Fludarabine Phosphate Injection in previously untreated or non-refractory patients with CLL have not been established.
Drug interactions
Known interactions involving Fludarabine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 321. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL123750040 · revised April 17, 2026
- [2]Health Canada (DPD) · 02283859 · revised June 10, 2025
- [3]FDA DailyMed · 0170c0f4-d502-4f… · revised January 31, 2023 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.