There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=
=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=
* Condition1
<!--Warnings-->
|warnings=
* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=
* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=
* '''Pregnancy Category'''
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=
* Oral
* Intravenous
|monitoring=
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose=
===Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=
<!--Mechanism of Action-->
|mechAction=
*
<!--Structure-->
|structure=
*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
<!--Pharmacodynamics-->
|PD=
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
|PK=
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
<!--Nonclinical Toxicology-->
|nonClinToxic=
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
<!--Clinical Studies-->
|clinicalStudies=
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
<!--How Supplied-->
|howSupplied=
*
<!--Patient Counseling Information-->
|fdaPatientInfo=
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
<!--Precautions with Alcohol-->
|alcohol=
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Brand Names-->
|brandNames=
* ®<ref>{{Cite web | title = | url = }}</ref>
==Overview==
<!--Look-Alike Drug Names-->
'''Fludarabine''' (marketed as '''fludarabine phosphate''' under the trade name '''Fludara''') is a [[chemotherapy]] drug used in the treatment of [[hematological malignancy|hematological malignancies]].
==Indications==
|lookAlike=
Fludarabine is highly effective in the treatment of chronic lymphocytic leukemia, producing higher response rates than [[alkylating antineoplastic agent|alkylating agent]]s such as [[chlorambucil]] alone.<ref name=Rai>Rai KR et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med 2000;343:1750-7. PMID 11114313</ref>
Fludarabine is used in various combinations with [[cyclophosphamide]], [[mitoxantrone]], [[dexamethasone]] and [[rituximab]] in the treatment of indolent [[lymphoma|non-Hodgkins lymphomas]]. As part of the ''FLAG'' regimen, fludarabine is used together with [[cytarabine]] and [[granulocyte colony-stimulating factor]] in the treatment of [[acute myeloid leukaemia]]. Because of its immunosuppressive effects, fludarabine is also used in some conditioning regimens prior to [[bone marrow transplant|non myeloablative allogeneic stem cell transplant]].
==Pharmacology==
* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
Fludarabine is a [[purine]] [[analog (chemistry)|analog]], and can be given both orally and intravenously. Fludarabine inhibits [[DNA synthesis]] by interfering with [[ribonucleotide reductase]] and [[DNA polymerase]]. It is active against both dividing and resting cells.
==Side effects==
<!--Drug Shortage Status-->
Fludarabine is associated with profound lymphopenia, and as a consequence, increases the risk of [[opportunistic infection]]s significantly. Patients who have been treated with fludarabine will usually be asked to take [[co-trimoxazole]] or to use monthly nebulised [[pentamidine]] to prevent [[Pneumocystis jiroveci pneumonia|''Pneumocystis jiroveci'' pneumonia]]. The profound lymphopenia caused by fludarabine renders patients susceptible to [[transfusion-associated graft versus host disease]], a fatal complication of [[blood transfusion]]. For this reason, all patients who have ever received fludarabine should only be given [[irradiation|irradiated]] blood components.
Fludarabine causes anemia, thrombocytopenia and [[neutropenia]], requiring regular blood count monitoring. Some patients require blood and [[platelet]] transfusion, or [[granulocyte colony-stimulating factor|G-CSF]] injections to boost [[neutrophil]] counts.
|drugShortage=
}}
Fludarabine is associated with the development of severe [[autoimmune hemolytic anemia]] in a proportion of patients.<ref name=Gonzalez>Gonzalez H et al. Severe autoimmune hemolytic anemia in eight patients treated with fludarabine. Hematol Cell Ther. 1998;40:113-8. PMID 9698219</ref>
<!--Pill Image-->
Difficulties are often encountered when harvesting peripheral blood stem cells from patients previously treated with fludarabine.<ref name=Tournilhac>Tournilhac O et al. Impact of frontline fludarabine and cyclophosphamide combined treatment on peripheral blood stem cell mobilization in B-cell chronic lymphocytic leukemia. Blood 2004;103:363-5. PMID 12969985</ref>
{{PillImage
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
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==References==
<!--Label Display Image-->
<references/>
==External links==
{{LabelImage
* [http://www.fludara.com/ Fludara webpage]
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}
{{Chemotherapeutic agents}}
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Fludarabine (injection) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Fludarabine (injection) in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fludarabine (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Fludarabine (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Fludarabine (injection) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fludarabine (injection) in pediatric patients.
Contraindications
Condition1
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Fludarabine (injection) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Fludarabine (injection) in the drug label.