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{{drugbox | IUPAC_name = 5-(6-amino-2-chloro-purin-9-yl) -4-fluoro-2- (hydroxymethyl)oxolan-3-ol | image = Clofarabine.svg | CAS_number = 123318-82-1 | ATC_prefix = L01 | ATC_suffix = BB06 | ATC_supplemental = | PubChem = 119182 | DrugBank = APRD00878 | C = 10 | H = 1 | Cl = 1 | F = 1 | N = 5 | O = 3 | molecular_weight = 303.677 g/mol | bioavailability = | protein_bound =  | metabolism = | elimination_half-life = | pregnancy_category = | legal_status = | routes_of_administration = }}
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* Content


==Overview==
<!--Adult Indications and Dosage-->
'''Clofarabine''' is a substance that is being studied in the treatment of [[cancer]]. It is a [[purine]] [[nucleoside]] [[antimetabolite]].  It is marketed in the [[United States|U.S.]] and [[Canada]] as '''Clolar'''. In [[Europe]] and [[Australia]]/[[New Zealand]] the product is marketed under the name '''Evoltra'''.


It is used in [[paediatric]]s to treat a type of [[leukaemia]] called relapsed or refractory [[acute lymphoblastic leukaemia]] (ALL), only after at least two other types of treatment have failed.  It is not known if extends life expectancy.  Some investigations of effectiveness in cases of  [[acute myeloid leukaemia]] (AML) and juvenile myelomonocytic leukaemia (JMML) have been carried out.
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====


==Side effects==
* Dosing Information
* [[Tumor lysis syndrome]] (TLS). Clofarabine quickly kills leukaemia cells in the blood. The body may react to this. Symptoms include fast breathing, fast heartbeat, low blood pressure, and fluid in the lungs. TLS is very serious and can lead to death if it is not treated right away.
*Bone marrow problems (suppression). Clofarabine can stop the bone marrow from making enough [[red blood cells]], [[white blood cells]], and [[platelets]]. Serious side effects that can happen because of bone marrow suppression include severe infection ([[sepsis]]), bleeding, and [[anemia]].
*Effects on [[pregnancy]] and [[breastfeeding]]. Girls and women should not become pregnant or breastfeed during treatment which harm the baby.
*[[Dehydration]] and [[low blood pressure]]. Clofarabine can cause [[vomit]]ing and [[diarrhea]] which may lead to low body fluid (dehydration). Signs and symptoms of dehydration include dizziness, lightheadedness, fainting spells, or decreased [[urination]].
*Other side effects. The most common side effects are stomach problems (including vomiting, diarrhea, and [[nausea]]), and effects on blood cells (including low red blood cells count, low white blood cell count, low platelet count, [[fever]], and infection. Clofarabine can also cause [[tachycardia]] and can affect the [[liver]] and [[kidneys]].


==Contraindications==
:* Dosage
*pregnancy or planned pregnancy
*breast-feeding
*liver problems
*kidney problems


==Drug interactions==
=====Condition2=====
*nephrotoxic drugs
*hepatotoxic drugs


==Delivery==
* Dosing Information
*By [[intravenous infusion]].
*Dosage is a 2 hour infusion (52 mg/m²) every day for five days. The cycle is repeated every 2 to 6 weeks.
*Regular blood tests to monitor his or her blood cells, kidney function, and liver function.


==Results of clinical trials==
:* Dosage
Efficacy and safety were demonstrated in a single multi-center trial that enrolled 40 patients aged 2-19. The patients were suffering  with relapsed or refractory acute lymphoblastic leukaemia (ALL) (An additional 9 patients suffering with [[acute myelogenous leukaemia]] (AML) had similar [[pharmacokinetics]] but are not included in the figure below.) Most patients had received 2 to 4 prior regimens and 15/49 (31%) had undergone at least one [[transplant]].  The median age was 12 years.  Clofarabine was given at a dose of 52 mg/m<sup>2</sup>, intravenously, over 2 hours daily x 5 repeated every 2 to 6 weeks following recovery or return to baseline organ function.  The study endpoints were the rate of complete response (CR) and the rate of complete response without platelet recovery (CRp).  The former was defined as no evidence of circulating [[blast]]s or extramedullary disease, an M1 [[bone marrow]], and recovery of peripheral platelet and absolute [[neutrophil]] counts; the latter was defined as meeting all criteria for CR except for platelet count recovery.  Response rates were determined by an Independent Response Review Panel (IRRP).


Six patients (12%) achieved a CR and 4 patients (8%) achieved a CRp, and 5 patients (10%) achieved a PR.  Of the 15 responding patients, 6 had post-clofarabine bone marrow transplantation.  Hence, response durations could not be determined.  In the patients who were not transplanted, the response durations for CR were 43, 50, 82, 93+, and 160+ days; for CRp the response duration was 32 days.
=====Condition3=====


The principal clofarabine toxicities were nausea, vomiting, hematologic toxicity, [[febrile neutropenia]], [[hepatobiliary toxicity]], infections and renal toxicity. Clofarabine can produce [[systemic inflammatory response syndrome]]/[[capillary leak syndrome]] (SIRS), manifested by the rapid development of [[tachypnea]], tachycardia, [[hypotension]], shock, and multi-organ failure. Cardiac toxicity was characterized as [[left ventricle|left ventricular]] [[systolic dysfunction]]; tachycardia may also occur.
* Dosing Information


==Approval==
:* Dosage
Clolar [[Food and Drug Administration]] (FDA) Approved [[28 december]] [[2004]]. (Under accelerated approval regulations requiring further clinical studies.)


==Patents==
=====Condition4=====
*{{US patent|4751221}}
*{{US patent|4918179}}
*{{US patent|5384310}}
*{{US patent|5661136}}
*{{US patent|6680382}}


==External links==
* Dosing Information
* [http://www.cancerbackup.org.uk/Treatments/Chemotherapy/Individualdrugs/Clofarabine Clofarabine information on Cancerbackup.]
* [http://www.fda.gov/cder/foi/label/2004/021673lbl.pdf FDA usage leaflet.]
* [http://www.clolar.com/home/clo_homepage.asp Clolar.com homepage.]
* [http://www.genzymeoncology.com/onc/products/clolar/onc_p_clolar.asp FDA approval notice.]
{{Chemotherapeutic agents}}


[[Category:Chemotherapeutic agents]]
:* Dosage
[[Category:Organofluorides]]
 
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[[Category:Drug]]

Revision as of 20:41, 17 February 2015

Clofarabine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Clofarabine is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. 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 Clofarabine in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clofarabine 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 Clofarabine 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 Clofarabine in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clofarabine in pediatric patients.

Contraindications

  • Condition1

Warnings

ConditionName:
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 Clofarabine 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 Clofarabine 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

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clofarabine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Clofarabine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Clofarabine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Clofarabine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Clofarabine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Clofarabine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Clofarabine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Clofarabine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Clofarabine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Clofarabine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Clofarabine in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Clofarabine in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Clofarabine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Clofarabine in the drug label.

Pharmacology

There is limited information regarding Clofarabine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Clofarabine01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Clofarabine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Clofarabine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Clofarabine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Clofarabine in the drug label.

How Supplied

Storage

There is limited information regarding Clofarabine Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Clofarabine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Clofarabine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Clofarabine in the drug label.

Precautions with Alcohol

  • Alcohol-Clofarabine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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