Glatiramer acetate: Difference between revisions

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:*COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable.
:*COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable.
|fdaLIADPed======Condition1=====
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Glatiramer acetate in adult patients.
 
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Glatiramer acetate in adult patients.
* Dosing Information
|fdaLIADPed=*The safety and efficacy have not been established in pediatric patients
 
:* 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
|contraindications=* Condition1


Revision as of 19:36, 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

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Overview

Glatiramer acetate is a immunologic adjuvant that is FDA approved for the treatment of relapsing forms of multiple sclerosis.. Common adverse reactions include injection site reactions, vasodilatation, rash, dyspnea, and chest pain.

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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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)

  • The safety and efficacy have not been established in pediatric patients

Off-Label Use and Dosage (Pediatric)

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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