Glatiramer

Glatiramer
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: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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
• 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.

• Instructions for Use

• Remove one blister-packaged prefilled syringe from the refrigerated carton. Let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Visually inspect the syringe for particulate matter and discoloration prior to administration. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe.
• Areas for subcutaneous self-injection include arms, abdomen, hips, and thighs. The prefilled syringe is for single use only. Discard unused portions.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• The safety and effectiveness of COPAXONE have not been established in patients under 18 years of age.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

• Copaxone®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

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

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