Monograph
L01BB05 - Fludarabine |
Propably not porphyrinogenic |
PNP |
Rationale
Non-CYP metabolism. Side effects such as nausea, vomiting and anorexia may be potentially porphyrinogenic through reduction in caloric intake.
Chemical description
Fluorinated nucleotide analogue administered as phosphate, slightly soluble in water.
Therapeutic characteristics
Fludarabine is an antimetabolite antineoplastic agent used to treat chronic lymphatic leucemia of B-cell type in patients with sufficient bone marrow reserve. Administered orally or as an infusion. Common adverse reactions of fludarabine that can be confused with an acute porphyric attack are nausea, vomiting and peripheral neuropathy common. Side effects such as nausea, vomiting and anorexia may be potentially porphyrinogenic through reduction in caloric intake.
Metabolism and pharmacokinetics
Fludarabine phosphate is rapidly dephosphorylated followed by selective distribution to leucemic cells, whereit is rephosphorylated to the active triphosphate nucleotide. This is eliminated from target cells with a half life of about 23 hours. The active metabolite F-ara-A formed on dephosphorylation of fludarabine is largely eliminatd by renal excretion (Ganhi et al, 2002). Not reported by Rendic (2002) as CYP-inductor or inhibitor.
IPNet drug reports
No.
References
# | Citation details | PMID |
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* | Scientific articles | |
1. | Gandhi, V., Plunkett, W. Cellular and Clinical Pharmacology of Fludarabine. Clin Pharmacokinet 2002; 41(2): 93-103.
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11888330 |
2. | Rendic, S. Summary of information on human CYP enzymes: human P450 metabolism. Drug metabolism reviews 2002; 34(1&2), 83-448.
|
11996015 |
* | Drug reference publications | |
3. | McEvoy GK, editor. Fludarabine. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (03.12.09).
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|
4. | Sweetman SC, editor. Martindale: The complete drug reference. Fludarabine. Pharmaceutical Press 2009.
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|
* | Summary of Product Characteristics | |
5. | Norwegian medicines agency. Summary of Product Characteristics (SPC). FLUDARA.
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Similar drugs
Tradenames and packages
From some sources, we get a list of packages (United Kingdom, Ireland, Estonia).
Other sources contain more or less "clean" versions of the trade name (Denmark, Finland, Iceland, Lithuania, Norway).
What you see here is the raw data we get from each country, so there will appear to be duplicates. The bold names
are the searchable terms. The gray names that follow are all mapped to the bolded term.
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Netherlands
Fludara · Fludara 10 mg, filmomhulde tabletten · Fludara, poeder voor oplossing voor injectie of infusie 50 mg/flacon · Fludarabine · Fludarabine Sandoz 25 mg/ml, concentraat voor oplossing voor injectie of infusie · Fludarabinefosfaat · Fludarabinefosfaat - PCH 25 mg/ml, concentraat voor oplossing voor injectie/infusie · Fludarabinefosfaat Accord 25 mg/ml, concentraat voor oplossing voor injectie of infusieBelgium
Fludarabine · Fludarabine Accord Healthcare 25 mg/ml sol. inj./perf. (sol., à diluer) i.v. flac. · Fludarabine Sandoz 25 mg/ml sol. inj./perf. (sol., à diluer) i.v. flac. · Fludarabine Teva 25 mg/ml sol. inj./perf. (sol., à diluer) i.v. flac.United Kingdom
Fludara · Fludara 10mg tablets · Fludara 50mg powder for solution for injection vials · Fludarabine · Fludarabine phosphate 50mg powder for solution for injection vials · Fludarabine phosphate 50mg/2ml concentrate for solution for injection vials · Fludarabine phosphate · Fludarabine phosphate 50mg/2ml solution for injection vialsDenmark
Fludara · Fludarabinphosphat · Fludarabinphosphat "Ebewe" · Fludarabinphosphat "Teva"Norway
Fludara · Fludarabin Ebewe · Fludarabine Phosphate TevaPoland
Fludara · Fludarabine AccordLuxembourg
FLUDARABINE · FLUDARABINE TEVAIceland
Fludara · Fludarabin · Fludarabin Actavis · Fludarabin TevaFinland
Fludara · Fludarabin Ebewe · Fludarabine AccordLatvia
FludaraSerbia
Fludarabin · Fludarabin Ebewe® · Fludarabin Pliva
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