Oxaliplatin: Difference between revisions

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| IUPAC_name = ethanedioate;platinum(+2)cation; (2-aminocyclohexyl)amine
|authorTag=<!--Overview-->
| image = Oxaliplatin-2D-skeletal.png | width = 200 px
|aOrAn=a
| image2 = Oxaliplatin-3D-balls.png | width2 = 200
|hasBlackBoxWarning=Yes
| CAS_number = 63121-00-6
|adverseReactions=<!--Black Box Warning-->
| ATC_prefix = L01
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| ATC_suffix = XA03
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
| ATC_supplemental =
| PubChem = 77994
| DrugBank = APRD00186
| C=8 | H=14 | N=2 | O=4 | Pt=1
| molecular_weight = 395.27 g/mol
| bioavailability = Complete
| protein_bound =
| metabolism =
| elimination_half-life = ~10 - 25 minutes <ref>Ehrsson H, Wallin I, Yachnin J. ''Medical Oncology''. 2002; '''19''':251-265.</ref>
| pregnancy_category =
| legal_status =
| routes_of_administration = Intravenous
| excretion = Renal }}
{{SI}}


* Content


==Overview==
<!--Adult Indications and Dosage-->
'''Oxaliplatin''' is a [[platinum]]-based [[chemotherapy]] [[medication|drug]] in the same family as [[cisplatin]] and [[carboplatin]].  It is typically administered in combination with [[fluorouracil]] and [[leucovorin]] in a combination known as [[FOLFOX]] for the treatment of [[colorectal cancer]]. Compared to cisplatin the two [[amine]] groups are replaced by cyclohexyldiamine for improved antitumour activity. The chlorine ligands are replaced by the oxalato [[bidentate]] derived from [[oxalic acid]] in order to improve water solubility.


Oxaliplatin is marketed by [[Sanofi-Aventis]] under the trademark '''Eloxatin'''®.
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====


== Mechanism of action and efficacy ==
* Dosing Information


The exact mechanism of action of oxaliplatin is not known. In vivo studies showed oxaliplatin has anti-tumor activity against colon carcinoma through its (non-targeted) [[cytotoxic]] effects. Median patient survival is approximately 5 months greater compared to the previous standard treatment.
:* Dosage


== Side-effects ==
=====Condition2=====
Side-effects of oxaliplatin treatment can potentially include:
* [[Neuropathy]], (both an acute, reversible sensitivity to cold and numbness in the hands and feet and a chronic, possibly irreversible foot/leg, hand/arm numbness, often with deficits in [[proprioception]])<ref name=pasetto>Pasetto LM, D'Andrea MR, Rossi E, Monfardini S. Oxaliplatin-related neurotoxicity: how and why? Crit Rev Oncol Hematol. 2006 Aug;59(2):159-68. Epub 2006 Jun 27. PMID 16806962.</ref>
* [[Fatigue (physical)|Fatigue]]
* [[Nausea]], [[vomiting]], and/or [[diarrhea]]
* [[Neutropenia]]
* [[Ototoxicity]] (hearing loss)


In addition, some patients may experience an [[allergy|allergic reaction]] to platinum-containing drugs.
* Dosing Information


Oxaliplatin has less ototoxicity and [[nephrotoxicity]] than cisplatin and carboplatin.<ref name=pasetto/>
:* Dosage


==History==
=====Condition3=====
Oxaliplatin was discovered in 1976 at Nagoya City University in Japan by Professor Yoshinori Kidani, who was granted U.S. Patent 4,169,846 over the drug in 1979. Oxaliplatin was subsequently in-licensed by Debiopharm, a Swiss drug company headquartered in Lausanne and developed as an advanced colorectal cancer treatment. Debio licensed the drug to [[Sanofi-Aventis]] in 1994. Eloxatin gained European approval in 1999 and [[FDA]] approval in 2004.


== Patent information ==
* Dosing Information
Eloxatin is covered by patent numbers 5338874 (Expiry Apr 07,2013), 5420319 (Expiry Aug 08,2016), 5716988 (Expiry Aug 07,2015) and 5290961 (Expiry Jan 12, 2013) (see Electronic Orange Book patent info for Eloxatin).<ref name=021759>Orange Book. accessdata.fda.gov. URL: [http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021759&Product_No=001&table1=OB_Rx http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021759&Product_No=001&table1=OB_Rx]. Accessed on: July 22, 2007.</ref> Exclusivity code I-441, which expires on Nov 04, 2007, is for use combination with infusional 5-FU/LV for adjuvant treatment stage III colon cancer patients who have undergone complete resection primary tumor-based on improvement in disease free survival with no demonstrated benefit overall survival after 4 years.  Exclusivity code NCE, New Chemical Entity, expires on Aug 09, 2007.<ref name=021759/>


== References ==
:* Dosage
<references/>


==Additional sources==
=====Condition4=====
* {{cite journal | author = Graham J, Mushin M, Kirkpatrick P | title = Oxaliplatin. | journal = Nat Rev Drug Discov | volume = 3 | issue = 1 | pages = 11-2 | year = 2004 | id = PMID 14756144 | url=http://www.dresources.com/nature/ntr_0104.pdf | format=PDF}}


==External links==
* Dosing Information
* [http://www.eloxatin.com Eloxatin] - web site of manufacturer.
* [http://www.virtualcancercentre.com/drugs.asp?drugid=1777 Virtual Cancer Centre: Oxaliplatin/Eloxatin]
* [http://www.cancer.gov/cancertopics/druginfo/oxaliplatin NCI Drug Information Summary on Oxaliplatin]


{{Chemotherapeutic agents}}
:* Dosage


[[Category:Chemotherapeutic agents]]
<!--Off-Label Use and Dosage (Adult)-->
[[Category:Platinum compounds]]
[[Category:Coordination compounds]]


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Revision as of 14:20, 23 January 2015

Oxaliplatin
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

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Black Box Warning

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

Overview

Oxaliplatin is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} 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 Oxaliplatin in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxaliplatin 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 Oxaliplatin 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 Oxaliplatin 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 Oxaliplatin in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Oxaliplatin01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Oxaliplatin 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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