The Pharmacokinetics and Pharmacodynamics of Fludarabine Phosphate in Patients with Renal Impairment: A Prospective Dose Adjustment Study

Lichtman, Stuart M.; Etcubanas, Erlinda; Budman, Daniel R.; Eisenberg, Peter D.; Zervos, George; D'Amico, Paul; O'Mara, Vivian; Musgrave, Kimberly; Cascella, Peter J.; Melikian, A M; Hinderling, Peter H.; Ferrer, Jorge; Williams, Gary J.

doi:10.1081/cnv-120005903

Cited by 63 publications

(34 citation statements)

References 13 publications

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“…This is an important question because of the number of reported FC protocols, and also because FC dosage is frequently modified as part of planned or unplanned decision making because of the frequency of FC-induced neutropenia and the interference between F and renal insufficiency. 15 …”

Section: Introductionmentioning

confidence: 99%

Impact of dose intensity on outcome of fludarabine, cyclophosphamide, and rituximab regimen given in the first-line therapy for chronic lymphocytic leukemia

et al. 2012

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Section: Introductionmentioning

confidence: 99%

Impact of dose intensity on outcome of fludarabine, cyclophosphamide, and rituximab regimen given in the first-line therapy for chronic lymphocytic leukemia

et al. 2012

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“…when possible, melphalan should be replaced by cyclophosphamide, which is better tolerated by patients with impaired renal function [31]. in terms of immunomodulators, thalidomide should be used as a first-line drug before lenalidomide because it does not require dose reduction in patients with impaired kidney function [32]. Fludarabine, an adenine nucleoside analogue, should be avoided in patients with severe renal impairment [32].…”

Section: Treatment Elimination Of Monoclonal B Clonementioning

confidence: 99%

“…in terms of immunomodulators, thalidomide should be used as a first-line drug before lenalidomide because it does not require dose reduction in patients with impaired kidney function [32]. Fludarabine, an adenine nucleoside analogue, should be avoided in patients with severe renal impairment [32]. Bendamustine is not metabolised in the kidneys and may be given to patients with MGrS without modification due to renal function parameters [33,34].…”

Section: Treatment Elimination Of Monoclonal B Clonementioning

confidence: 99%

Monoclonal gammopathy with renal significance

Sysakiewicz¹,

Czyż²,

Ksieniewicz³

et al. 2016

Medical Research Journal

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Monoclonal gammopathy of unknown significance (MGUS) is a benign condition that carries a risk of progression to haematological malignancy. It is accepted that MGUS should not be treated until progression to multiple myeloma or another lymphoid malignancy. Recently, growing evidence has started to show that even small monoclonal clones can be responsible for renal impairment. Long-term observation of patients with monoclonal gammopathy and abnormal renal function showed that this condition can significantly affect renal and overall survival. Patients with monoclonal gammopathy with renal impairment have also higher risk of relapse after kidney transplantation. Among patients with monoclonal gammopathy of unknown significance there is a group of defined monoclonal component-related diseases, which includes:light-chain amyloidosis, monoclonal immunoglobulin deposition disease, crystal-storing histiocytosis, cryoglobulinaemias, and some others. They can be diagnosed on the base of clinical features and on histological examination. In patients with monoclonal protein and deposition of fragments or whole particle of monoclonal immunoglobulin with distinct localisation and substructural organisation can be found.The treatment strategy is targeting of B cell clones, which requires administration of chemotherapeutics or other medications that are used for the treatment of lymphoid malignancy or myeloma. The choice of therapeutic agent should take into account the current kidney status. Treatment of renal disease should not differ from other patients with similar conditions not related to monoclonal protein. The expert opinion is that the presence of monoclonal gammapathy is not a contraindication to kidney transplantation.

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“…After intravenous administration, fludarabine is rapidly dephosphorylated to the primary metabolite, 9-β-D-arabinofuranosyl-2-fluoroadenine (F-ara-A), which is re-phosphorylated intracellularly by deoxycytidine kinase to fludarabine and subsequently to the active metabolite, 9-β-D-arabinofuranosyl-2-fluoroadenine triphosphate (F-ara-ATP). This active metabolite acts by inhibiting DNA polymerase α, ribonucleotide reductase and DNA primase, thus inhibiting DNA and RNA synthesis and apoptosis [2,5].…”

Section: Introductionmentioning

confidence: 99%

The stability of fludarabine phosphate in concentrate and diluted with sodium chloride 0.9%

Szałek¹,

Kamińska²,

Urjasz³

et al. 2011

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Background: To determine the stability of fludarabine phosphate in concentrate in glass containers and diluted with sodium chloride 0.9% in polyethylene (PE) bags. Material and methods: Solutions of fludarabine phosphate 25 mg/ml (concentrate) in glass containers (n = 6) were opened and stored at refrigerator temperature (2-8°C) and at room temperature (15-25°C). Another six solutions of fludarabine phosphate were diluted in NaCl 0.9% and stored in PE bags in the same conditions (2-8°C and 15-25°C). Samples of each solution from the 12 containers were analysed for fludarabine phosphate concentration initially and after 0.5, 1, 1.5, 2, 2.5, 3, 13 and 15 days of storage. Samples were assayed by a high performance liquid chromatographic (HPLC) method with ultraviolet detection (λ = 265 nm) to determine the fludarabine phosphate concentration at each time of sampling. Results: The concentration of fludarabine phosphate at each sampling time in the analysed solutions remained within 93.3-102.0% of the initial concentration, regardless of the storage temperature and container. Conclusions: Fludarabine phosphate, both undiluted in glass containers and diluted with NaCl 0.9% in PE bags, remains stable (< 10% degradation) for at least 15 days at room and refrigerator temperature.

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The Pharmacokinetics and Pharmacodynamics of Fludarabine Phosphate in Patients with Renal Impairment: A Prospective Dose Adjustment Study

Abstract: The CLcr-based fludarabine dose adjustments used in this study provided reasonably equivalent F-ara-A exposure with acceptable safety in patients with varying degrees of renal function.

Cited by 63 publications

References 13 publications

Impact of dose intensity on outcome of fludarabine, cyclophosphamide, and rituximab regimen given in the first-line therapy for chronic lymphocytic leukemia

Impact of dose intensity on outcome of fludarabine, cyclophosphamide, and rituximab regimen given in the first-line therapy for chronic lymphocytic leukemia

Monoclonal gammopathy with renal significance

The stability of fludarabine phosphate in concentrate and diluted with sodium chloride 0.9%

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