Glatiramer acetate: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=
|authorTag={{DB}}
 
|genericName=Glatiramer acetate
 
|aOrAn=a
<!--Overview-->
|drugClass=immunologic adjuvant
 
|indicationType=treatment
|genericName=
|indication=relapsing forms of multiple sclerosis.
 
|adverseReactions=<!--Black Box Warning-->
 
|blackBoxWarningTitle=Title
 
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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* Content
* Content
Line 42: Line 15:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Multiple sclerosis=====


|fdaLIADAdult=
*COPAXONE is indicated for the treatment of patients with relapsing forms of multiple sclerosis.


=====Condition1=====
* Dosing Information


* Dosing Information
:* COPAXONE is for subcutaneous use only. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are:
:*COPAXONE 20 mg per mL: administer once per day or
:*COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart


:* Dosage
COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable.


=====Condition2=====
=====Condition2=====
Line 72: Line 48:


<!--Guideline-Supported Use (Adult)-->
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport=
 
=====Condition1=====


* Developed by:  
* Developed by:  
Line 92: Line 65:


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=
 
=====Condition1=====


* Dosing Information
* Dosing Information
Line 108: Line 78:


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed======Condition1=====
|fdaLIADPed=
 
=====Condition1=====


* Dosing Information
* Dosing Information
Line 124: Line 91:


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=
 
=====Condition1=====


* Developed by:  
* Developed by:  
Line 144: Line 108:


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=
 
=====Condition1=====


* Dosing Information
* Dosing Information
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<!--Contraindications-->
<!--Contraindications-->
 
|contraindications=* Condition1
|contraindications=
 
* Condition1


<!--Warnings-->
<!--Warnings-->
 
|warnings=* Description
|warnings=
 
* Description


====Precautions====
====Precautions====
Line 176: Line 131:


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
 
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====
=====Body as a Whole=====
Line 246: Line 198:


<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
 
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====
=====Body as a Whole=====
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|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInGeri=
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|administration=
 
* Oral


* Intravenous
* Intravenous
 
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|monitoring=
 
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* Description
* Description


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|IVCompat=
 
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<!--Overdosage-->
<!--Overdosage-->
 
|overdose====Acute Overdose===
|overdose=
 
===Acute Overdose===


====Signs and Symptoms====
====Signs and Symptoms====
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: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
 
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|PD=
 
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<!--Pharmacokinetics-->
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|PK=
 
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<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
 
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<!--Clinical Studies-->
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|fdaPatientInfo=
 
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<!--Precautions with Alcohol-->
<!--Precautions with Alcohol-->
 
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
 
|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>
|brandNames=
 
* ®<ref>{{Cite web | title =  | url =  }}</ref>


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|lookAlike=
 
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


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{{PillImage
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<!--Label Display Image-->
<!--Label Display Image-->


{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


{{LabelImage
 
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
 
}}


<!--Category-->
<!--Category-->


[[Category:Drug]]
[[Category:Drug]]

Revision as of 19:27, 10 September 2014

Glatiramer acetate
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: Deepika Beereddy, MBBS [2]

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.

Overview

Glatiramer acetate is a immunologic adjuvant that is FDA approved for the treatment of relapsing forms of multiple sclerosis.. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Multiple sclerosis
  • COPAXONE is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
  • Dosing Information
  • COPAXONE is for subcutaneous use only. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are:
  • COPAXONE 20 mg per mL: administer once per day or
  • COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart

COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable.

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 Glatiramer acetate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Glatiramer acetate 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 Glatiramer acetate 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 Glatiramer acetate in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Glatiramer acetate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Glatiramer acetate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Glatiramer acetate Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Glatiramer acetate 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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Retrieved from "https://www.wikidoc.org/index.php?title=Glatiramer_acetate&oldid=1020184"