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Glatiramer (Monograph)

Brand names: Copaxone, Glatopa [Web])
Drug class: Immunomodulatory Agents
- Immunomodulatory Agents
Chemical name: l-Glutamic acid polymer with l-alanine, l-lysine, and l-tyrosine, acetate
Molecular formula: C5H9NO4 • C3H7-5H9NO4 • C3H7NO2 • C6H14N2O2 • C9H11NO3)x • xC2H4O2)
CAS number: 147245-92-9

Medically reviewed by on Aug 19, 2022. Written by ASHP.


Synthetic polypeptide mixture containing 4 naturally occurring amino acids with immunomodulatory and disease-modifying activity in multiple sclerosis.

Uses for Glatiramer

Multiple Sclerosis (MS)

Treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS.

Glatiramer acetate is one of several disease-modifying therapies used in the management of relapsing forms of MS. Although not curative, these therapies have all been shown to modify several measures of disease activity, including relapse rates, new or enhancing MRI lesions, and disability progression.

The American Academy of Neurology (AAN) recommends that disease-modifying therapy be offered to patients with relapsing forms of MS who have had recent relapses and/or MRI activity. Clinicians should consider adverse effects, tolerability, method of administration, safety, efficacy, and cost of the drugs in addition to patient preferences when selecting an appropriate therapy.

Has been evaluated for primary progressive MS (PPMS) [off-label].

Glatiramer Dosage and Administration


Patient Monitoring

Dispensing and Administration Precautions


Administer only by sub-Q injection; do not administer IV.

Sub-Q Administration

Commercially available prefilled syringes intended for single use only; discard unused portion.

Allow prefilled syringes to reach room temperature by removing from refrigerator about 20 minutes prior to use.

Inject sub-Q into the arm, abdomen, hip, or thigh.

Localized lipoatrophy and skin necrosis reported; to minimize risk, follow proper injection technique and rotate injection sites with each injection.


Available as glatiramer acetate; dosage expressed in terms of the salt.


Multiple Sclerosis

Dosage recommendations differ based on dosage strength (20 or 40 mg/mL) used. Dosage strengths are not interchangeable.

If using the 20-mg/mL injection, recommended dosage is 20 mg once daily.

If using the 40-mg/mL injection, recommended dosage is 40 mg 3 times a week (administer injections at least 48 hours apart).

Special Populations

No special population dosage recommendations at this time.

Cautions for Glatiramer



Immediate Post-injection Reaction

Acute injection reactions reported after sub-Q injection. Symptoms, which are generally transient and self-limited and do not require treatment, include flushing, chest pain or tightness, palpitations, anxiety, dyspnea, constriction of the throat, tachycardia, and urticaria. Majority of symptoms occur within 1 hour, but may occur within seconds to minutes of administration.

Chest Pain

Transient chest pain reported, usually presenting >1 month after initiation of therapy. Some episodes occurred as part of immediate post-injection reactions, but many did not. Episodes generally last only a few minutes, often are not associated with other symptoms, and do not appear to produce clinically important sequelae. Some patients experience more than one such episode.

Lipoatrophy and Skin Necrosis

Localized lipoatrophy (i.e., loss of subcutaneous fat) and, rarely, skin necrosis at the injection site reported. Lipoatrophy may occur at various times after treatment initiation, sometimes after several months and is thought to be permanent. No known treatment for lipoatrophy.

Advise patients to follow proper injection technique and rotate injection sites daily to minimize risk.

Potential Effects on Immune Response

Possible modification of immune response and interference with useful immune function.

Possible interference with the recognition of foreign antigens, which may undermine the body’s tumor surveillance ability and defenses against infection.

Possibility of adverse effects resulting from continued alteration of cellular immunity associated with chronic administration of the drug.

Antibody Formation

Development of IgG antibodies to glatiramer reported in most patients; however, data to date indicate that antibodies do not neutralize therapeutic effects.

Animal studies suggest that immune complexes are deposited in renal glomeruli.

Hepatic Injury

Hepatic injury, including liver failure and hepatitis with jaundice, reported. May occur at various times after treatment initiation, most often within 1–3 months; generally self-limited after discontinuation of the drug.

Specific Populations


Insufficient information to determine whether there is a drug-associated risk when used during pregnancy. No fetal harm observed in animal reproduction studies.


Not known whether glatiramer is distributed into milk; the effects on nursing infants or on milk production also unknown. Consider benefits of breast-feeding along with mother's clinical need for glatiramer acetate and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.

Has been used for pediatric-onset MS (POMS) [off-label]; however, well-controlled studies with prolonged follow-up needed to assess long-term efficacy and safety.

Geriatric Use

Not studied in geriatric patients.

Renal Impairment

Pharmacokinetics not studied.

Common Adverse Effects

The most common adverse effects reported with glatiramer acetate 20 mg/mL (≥10%) include injection site reactions, vasodilatation, rash, dyspnea, and chest pain.

The most common adverse effect reported with glatiramer acetate 40 mg/mL (≥10%) was injection site reactions.

Drug Interactions

Interactions with other drugs not fully evaluated to date.

No clinically important interactions reported with drugs commonly used in MS, including concurrent corticosteroid therapy for up to 28 days. Not formally evaluated in combination with interferon beta.

Glatiramer Pharmacokinetics


Following sub-Q injection, some portion of the dose may enter the lymphatic circulation and some may enter systemic circulation. Does not appear to cross the blood-brain barrier.



Substantial portion of sub-Q dose appears to be hydrolyzed locally at injection site to small oligopeptides and free amino acids.





2–8°C; protect from light. May be stored at room temperature (15–30°C) for ≤1 month. Do not freeze.


Advice to Patients


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Glatiramer Acetate


Dosage Forms


Brand Names



Injection, for subcutaneous use

20 mg/1 mL*

Copaxone (available as 1-mL prefilled syringe)

Teva Neuroscience

Glatiramer Acetate Injection (available as 1-mL prefilled syringe)

Glatopa (available as 1-mL prefilled syringe)


40 mg/1 mL*

Copaxone (available as 1-mL prefilled syringe)

Teva Neuroscience

Glatiramer Acetate Injection (available as 1-mL prefilled syringe)

Glatopa (available as 1-mL prefilled syringe)


AHFS DI Essentials™. © Copyright 2024, Selected Revisions August 19, 2022. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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