Difference between revisions of "Fludarabine (Fludara)"

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==General information==
 
==General information==
−
Class/mechanism: Purine analog, antimetabolite; fludarabine is converted to the active compound, 2-fluoro-ara-ATP, which inhibits DNA synthesis by inhibiting DNA polymerase alpha, ribonucleotide reductase, and DNA primase. Relatively resistant to deamination by adenosine deaminase. The mechanism of action is not completely characterized and may be multi-faceted.<ref name="insert">[http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4067b1_15_fludarabine%20label.pdf Fludarabine (Fludara) package insert]</ref><ref>[[Media:Fludarabine.pdf | Fludarabine (Fludara) package insert (locally hosted backup)]]</ref>
+
Class/mechanism: Purine analog, antimetabolite; fludarabine is converted to the active compound, 2-fluoro-ara-ATP, which inhibits DNA synthesis by inhibiting DNA polymerase alpha, ribonucleotide reductase, and DNA primase. Relatively resistant to deamination by adenosine deaminase. The mechanism of action is not completely characterized and may be multi-faceted.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020038s032lbl.pdf Fludarabine (Fludara) package insert]</ref><ref>[[:File:Fludarabine.pdf | Fludarabine (Fludara) package insert (locally hosted backup)]]</ref>
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<br>Route: IV
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<br>Route: IV, PO ''Note: Oral fludarabine is no longer available in the US, at this time.''
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<br>Extravasation: no information
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<br>Extravasation: [[neutral]]
  
−
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>  
+
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>  
 +
 
 +
==Diseases for which it is established ''(work in progress)''==
 +
*Non-Hodgkin lymphoma
 +
**[[Follicular lymphoma]]
 +
**[[Mantle cell lymphoma]]
 +
**[[Marginal zone lymphoma]]
 +
**[[Waldenström macroglobulinemia]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Acute myeloid leukemia]]
 
*[[Acute myeloid leukemia]]
−
*[[Aggressive Non-Hodgkin lymphoma]]
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**[[Acute myeloid leukemia, FLT3-positive]]
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*[[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL)]]
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*[[Anaplastic large cell lymphoma]]
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*[[Follicular lymphoma]]
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*[[B-cell acute lymphoblastic leukemia]]
−
*[[Mantle cell lymphoma]]
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*[[B-cell lymphoma of mucosa-associated lymphoid tissue]]
−
*[[Marginal zone lymphoma]]
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*[[Chronic lymphocytic leukemia]]
−
*[[Transplant conditioning regimens]]
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*[[Cold agglutinin disease]]
−
*[[Waldenström macroglobulinemia]]
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*[[Diffuse large B-cell lymphoma]]
 +
*[[Classical Hodgkin lymphoma]]
 +
*[[NK- and T-cell lymphoma]]
 +
*[[Peripheral T-cell lymphoma]]
 +
*[[Primary mediastinal B-cell lymphoma]]
 +
*[[Transformed lymphoma]]
 +
 
 +
==Diseases for which it was used==
 +
*[[Multiple myeloma - historical|Multiple myeloma]]
 +
*[[Renal cell carcinoma - historical|Renal cell carcinoma]]
  
 
==Patient drug information==
 
==Patient drug information==
−
*[http://chemocare.com/chemotherapy/drug-info/fludarabine.aspx Fludarabine (Fludara) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/fludarabine.aspx Fludarabine (Fludara) patient drug information (Chemocare)]</ref>
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*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020038s032lbl.pdf Fludarabine (Fludara) package insert]<ref name="insert"></ref>
 +
*[https://chemocare.com/druginfo/fludarabine.aspx Fludarabine (Fludara) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/fludarabine.aspx Fludarabine (Fludara) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/fludarabine-patient-drug-information Fludarabine (Fludara) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/fludarabine-patient-drug-information Fludarabine (Fludara) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/fludarabine-patient-drug-information Fludarabine (Fludara) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/fludarabine-patient-drug-information Fludarabine (Fludara) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*4/18/1991: Initial FDA approval
+
*1991-04-18: Initial FDA approval for the treatment of patients with [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia (CLL)]] who have not responded to or whose disease has progressed during treatment with at least one standard [[:Category:Alkylating_agents|alkylating-agent]] containing regimen. ''(Based on Grever et al. 1990 & Keating et al. 1989)''
 +
==History of changes in EMA indication==
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*1994-08-11: EURD
 +
==History of changes in PMDA indication==
 +
*2007-01-26: New route of administation and additional indications for treatment of [[:Category:Indolent lymphomas|low-grade B-cell non-Hodgkin lymphoma]] and [[mantle cell lymphoma]].
 +
*2008-05-20: New indication and a new dosage for use as a conditioning prior to allogeneic hematopoietic stem cell transplantation in the following diseases: acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, chronic lymphocytic leukemia, malignant lymphoma, and multiple myeloma.
 +
*2009-11-06: New additional indication for the treatment of [[chronic lymphocytic leukemia]] with anemia or thrombocytopenia.
 +
*2009-11-06: New additional indications and a new dosage for the treatment of recurrent or refractory [[:Category:Indolent lymphomas|low-grade B-cell non-Hodgkin’s lymphoma]] and [[mantle cell lymphoma]].
 +
*2019-03-26: New indication for the treatment prior to tumor-specific T-cell infusion therapy.
 +
*2022-06-20: New indication and a new dosage for the treatment of relapsed or refractory [[acute myeloid leukemia]].
  
 
==Also known as==
 
==Also known as==
−
Beneflur, FAMP, Fludarabine Phosphate, Fludara Lyophilisat, Oforta, Trav Fludarabine.
+
*'''Generic names:''' FAMP, fludarabine phosphate
 +
*'''Brand names:''' Beneflur, Fludabine, Fludara, Lymfuda, Oforta
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
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[[Category:Drugs]]
−
[[Category:Chemotherapy]]
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[[Category:Intravenous medications]]
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[[Category:DNA synthesis inhibitors]]
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[[Category:Oral medications]]
−
[[Category:Nucleic acid analogs]]
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[[Category:Neutral]]
 +
 
 +
[[Category:Human DNA synthesis inhibitors]]
 +
[[Category:Antimetabolites]]
 +
[[Category:Purine analogs]]
 +
 
 
[[Category:Acute myeloid leukemia medications]]
 
[[Category:Acute myeloid leukemia medications]]
−
[[Category:Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) medications]]
+
[[Category:Anaplastic large cell lymphoma medications]]
 +
[[Category:B-cell acute lymphoblastic leukemia medications]]
 +
[[Category:Chronic lymphocytic leukemia medications]]
 +
[[Category:Cold agglutinin disease medications]]
 +
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
 +
[[Category:Classical Hodgkin lymphoma medications]]
 +
[[Category:MALT lymphoma medications]]
 +
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Marginal zone lymphoma medications]]
 
[[Category:Marginal zone lymphoma medications]]
−
[[Category:Transplant medications]]
+
[[Category:NK- and T-cell lymphoma medications]]
 +
[[Category:Peripheral T-cell lymphoma medications]]
 +
[[Category:Primary mediastinal B-cell lymphoma medications]]
 +
[[Category:Transformed lymphoma medications]]
 +
[[Category:Waldenström macroglobulinemia medications]]
 +
 
 +
[[Category:Multiple myeloma medications (historic)]]
 +
[[Category:Renal cell carcinoma medications (historic)]]
 +
 
 +
[[Category:FDA approved in 1991]]
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[[Category:EMA approved in 1994]]
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[[Category:WHO Essential Cancer Medicine]]

Revision as of 13:26, 23 September 2023

General information

Class/mechanism: Purine analog, antimetabolite; fludarabine is converted to the active compound, 2-fluoro-ara-ATP, which inhibits DNA synthesis by inhibiting DNA polymerase alpha, ribonucleotide reductase, and DNA primase. Relatively resistant to deamination by adenosine deaminase. The mechanism of action is not completely characterized and may be multi-faceted.[1][2]
Route: IV, PO Note: Oral fludarabine is no longer available in the US, at this time.
Extravasation: neutral

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

  • 1991-04-18: Initial FDA approval for the treatment of 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. (Based on Grever et al. 1990 & Keating et al. 1989)

History of changes in EMA indication

  • 1994-08-11: EURD

History of changes in PMDA indication

  • 2007-01-26: New route of administation and additional indications for treatment of low-grade B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
  • 2008-05-20: New indication and a new dosage for use as a conditioning prior to allogeneic hematopoietic stem cell transplantation in the following diseases: acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, chronic lymphocytic leukemia, malignant lymphoma, and multiple myeloma.
  • 2009-11-06: New additional indication for the treatment of chronic lymphocytic leukemia with anemia or thrombocytopenia.
  • 2009-11-06: New additional indications and a new dosage for the treatment of recurrent or refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.
  • 2019-03-26: New indication for the treatment prior to tumor-specific T-cell infusion therapy.
  • 2022-06-20: New indication and a new dosage for the treatment of relapsed or refractory acute myeloid leukemia.

Also known as

  • Generic names: FAMP, fludarabine phosphate
  • Brand names: Beneflur, Fludabine, Fludara, Lymfuda, Oforta

References

  1. ↑ 1.0 1.1 1.2 Fludarabine (Fludara) package insert
  2. ↑ Fludarabine (Fludara) package insert (locally hosted backup)
  3. ↑ Fludarabine (Fludara) patient drug information (Chemocare)
  4. ↑ Fludarabine (Fludara) patient drug information (UpToDate)
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