Oxaliplatin: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag={{RB}}
|genericName=oxaliplatin
|aOrAn=a
|aOrAn=a
|drugClass=antineoplasic agent
|indicationType=treatment
|indication=stage III colon cancer in patients who have undergone complete resection of the primary tumor,  advanced colorectal cancer
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* Anaphylactic reactions to ELOXATIN have been reported, and may occur within minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.
 
|fdaLIADAdult=====Indications====
<!--Adult Indications and Dosage-->
* ELOXATIN, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:
 
:* adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
<!--FDA-Labeled Indications and Dosage (Adult)-->
:* treatment of advanced colorectal cancer.
|fdaLIADAdult======Condition1=====
====Dosage====
 
* Administer ELOXATIN in combination with 5-fluorouracil/leucovorin every 2 weeks. For advanced disease, treatment is recommended until disease progression or unacceptable toxicity. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):
* Dosing Information
* Day 1: ELOXATIN 85 mg/m2 intravenous infusion in 250–500 mL 5% Dextrose injection, USP and leucovorin 200 mg/m2 intravenous infusion in 5% Dextrose Injection, USP both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
 
* Day 2: Leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
:* Dosage
: [[File:Oxaliplatin dosage.png|none|500px]]
 
* The administration of ELOXATIN does not require prehydration. Premedication with antiemetics, including 5-HT3 blockers with or without dexamethasone, is recommended.
=====Condition2=====
* For information on 5-fluorouracil and leucovorin, see the respective package inserts.
 
=====Dose Modification Recommendations=====
* Dosing Information
* Prior to subsequent therapy cycles, patients should be evaluated for clinical toxicities and recommended laboratory test. Prolongation of infusion time for ELOXATIN from 2 hours to 6 hours may mitigate acute toxicities. The infusion times for 5-fluorouracil and leucovorin do not need to be changed.
 
======Adjuvant Therapy in Patients with Stage III Colon Cancer======
:* Dosage
* Neuropathy and other toxicities were graded using the NCI CTC scale version 1.
 
* For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of ELOXATIN to 75 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-fluorouracil/leucovorin regimen need not be altered.
=====Condition3=====
* A dose reduction of ELOXATIN to 75 mg/m2 and infusional 5-fluorouracil to 300 mg/m2 bolus and 500 mg/m2 22 hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥1.5 × 109/L and platelets ≥75 × 109/L.
 
* Dose Modifications in Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer
* Dosing Information
* Neuropathy was graded using a study-specific neurotoxicity scale. Other toxicities were graded by the NCI CTC, Version 2.0.
 
* For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of ELOXATIN to 65 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The 5-fluorouracil/leucovorin regimen need not be altered.
:* Dosage
* A dose reduction of ELOXATIN to 65 mg/m2 and 5-fluorouracil by 20% (300 mg/m2 bolus and 500 mg/m2 22-hour infusion) is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥1.5 × 109/L and platelets ≥75 × 109/L.
 
* Dose Modifications in Therapy for Patients with Renal Impairment
=====Condition4=====
* In patients with normal renal function or mild to moderate renal impairment, the recommended dose of ELOXATIN is 85 mg/m2. In patients with severe renal impairment, the initial recommended ELOXATIN dose should be reduced to 65 mg/m2.
 
=====Preparation of Infusion Solution=====
* Dosing Information
* Do not freeze and protect from light the concentrated solution.
 
A final dilution must never be performed with a sodium chloride solution or other chloride-containing solutions.
:* Dosage
* The solution must be further diluted in an infusion solution of 250-500 mL of 5% Dextrose Injection, USP.
 
* After dilution with 250-500 mL of 5% Dextrose Injection, USP, the shelf life is 6 hours at room temperature [20-25°C (68-77°F)] or up to 24 hours under refrigeration [2-8°C (36-46°F)].
<!--Off-Label Use and Dosage (Adult)-->
* After final dilution, protection from light is not required.
 
* ELOXATIN is incompatible in solution with alkaline medications or media (such as basic solutions of 5-fluorouracil) and must not be mixed with these or administered simultaneously through the same infusion line. The infusion line should be flushed with 5% Dextrose Injection, USP prior to administration of any concomitant medication.
<!--Guideline-Supported Use (Adult)-->
* Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and discarded if present.
* Needles or intravenous administration sets containing aluminum parts that may come in contact with ELOXATIN should not be used for the preparation or mixing of the drug. Aluminum has been reported to cause degradation of platinum compounds.
====DOSAGE FORMS AND STRENGTHS====
* ELOXATIN is supplied in single-use vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


Line 56: Line 63:


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=* Breast Cancer<ref>{cite web|url=http://www.ncbi.nlm.nih.gov/pubmed/?term=Zelek+L%2C+Cottu+P%2C+Tubiana-Hulin+M%2C+et+al%3A+Phase+II+study+of+oxaliplatin+and+fluorouracil+in+taxane-+and+anthracycline-+pretreated+breast+cancer+patients.+J+Clin+Oncol+2002%3B+20%3A2551-2558.|Title=Phase II study of oxaliplatin and fluorouracil in taxane- and anthracycline-pretreated breast cancer patients.}</ref>
 
* 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=====
|fdaLIADPed======Condition1=====


Revision as of 14:42, 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]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Anaphylactic reactions to ELOXATIN have been reported, and may occur within minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.

Overview

Oxaliplatin is a antineoplasic agent that is FDA approved for the treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor, advanced colorectal cancer. There is a Black Box Warning for this drug as shown here. Common adverse reactions include peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • ELOXATIN, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:
  • adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
  • treatment of advanced colorectal cancer.

Dosage

  • Administer ELOXATIN in combination with 5-fluorouracil/leucovorin every 2 weeks. For advanced disease, treatment is recommended until disease progression or unacceptable toxicity. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):
  • Day 1: ELOXATIN 85 mg/m2 intravenous infusion in 250–500 mL 5% Dextrose injection, USP and leucovorin 200 mg/m2 intravenous infusion in 5% Dextrose Injection, USP both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
  • Day 2: Leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
  • The administration of ELOXATIN does not require prehydration. Premedication with antiemetics, including 5-HT3 blockers with or without dexamethasone, is recommended.
  • For information on 5-fluorouracil and leucovorin, see the respective package inserts.
Dose Modification Recommendations
  • Prior to subsequent therapy cycles, patients should be evaluated for clinical toxicities and recommended laboratory test. Prolongation of infusion time for ELOXATIN from 2 hours to 6 hours may mitigate acute toxicities. The infusion times for 5-fluorouracil and leucovorin do not need to be changed.
Adjuvant Therapy in Patients with Stage III Colon Cancer
  • Neuropathy and other toxicities were graded using the NCI CTC scale version 1.
  • For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of ELOXATIN to 75 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-fluorouracil/leucovorin regimen need not be altered.
  • A dose reduction of ELOXATIN to 75 mg/m2 and infusional 5-fluorouracil to 300 mg/m2 bolus and 500 mg/m2 22 hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥1.5 × 109/L and platelets ≥75 × 109/L.
  • Dose Modifications in Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer
  • Neuropathy was graded using a study-specific neurotoxicity scale. Other toxicities were graded by the NCI CTC, Version 2.0.
  • For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of ELOXATIN to 65 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The 5-fluorouracil/leucovorin regimen need not be altered.
  • A dose reduction of ELOXATIN to 65 mg/m2 and 5-fluorouracil by 20% (300 mg/m2 bolus and 500 mg/m2 22-hour infusion) is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥1.5 × 109/L and platelets ≥75 × 109/L.
  • Dose Modifications in Therapy for Patients with Renal Impairment
  • In patients with normal renal function or mild to moderate renal impairment, the recommended dose of ELOXATIN is 85 mg/m2. In patients with severe renal impairment, the initial recommended ELOXATIN dose should be reduced to 65 mg/m2.
Preparation of Infusion Solution
  • Do not freeze and protect from light the concentrated solution.

A final dilution must never be performed with a sodium chloride solution or other chloride-containing solutions.

  • The solution must be further diluted in an infusion solution of 250-500 mL of 5% Dextrose Injection, USP.
  • After dilution with 250-500 mL of 5% Dextrose Injection, USP, the shelf life is 6 hours at room temperature [20-25°C (68-77°F)] or up to 24 hours under refrigeration [2-8°C (36-46°F)].
  • After final dilution, protection from light is not required.
  • ELOXATIN is incompatible in solution with alkaline medications or media (such as basic solutions of 5-fluorouracil) and must not be mixed with these or administered simultaneously through the same infusion line. The infusion line should be flushed with 5% Dextrose Injection, USP prior to administration of any concomitant medication.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and discarded if present.
  • Needles or intravenous administration sets containing aluminum parts that may come in contact with ELOXATIN should not be used for the preparation or mixing of the drug. Aluminum has been reported to cause degradation of platinum compounds.

DOSAGE FORMS AND STRENGTHS

  • ELOXATIN is supplied in single-use vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.

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

  • Breast Cancer[1]

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:
  • Anaphylactic reactions to ELOXATIN have been reported, and may occur within minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.
  • 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. ↑ {cite web|url=http://www.ncbi.nlm.nih.gov/pubmed/?term=Zelek+L%2C+Cottu+P%2C+Tubiana-Hulin+M%2C+et+al%3A+Phase+II+study+of+oxaliplatin+and+fluorouracil+in+taxane-+and+anthracycline-+pretreated+breast+cancer+patients.+J+Clin+Oncol+2002%3B+20%3A2551-2558.%7CTitle=Phase II study of oxaliplatin and fluorouracil in taxane- and anthracycline-pretreated breast cancer patients.}
  2. ↑ Empty citation (help)
  3. ↑ "http://www.ismp.org". External link in |title= (help)

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