Glatiramer

The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS.

• Glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatopa is indicated for the treatment of relapsing-forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).ICD-10: G35

• Glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.contraindicated

• For subcutaneous injection only; doses are not interchangeable ( 2.1 ) • Glatopa 20 mg/mL per day ( 2.1 ) • Glatopa 40 mg/mL three times per week ( 2.1 ) • Before use, allow the solution to warm to room temperature ( 2.2 ) 2.1 Recommended Dose Glatopa is for subcutaneous use only. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are: • Glatopa 20 mg per mL: administer once per day or • Glatopa 40 mg per mL: administer three times per week and at least 48 hours apart. Glatopa 20 mg per mL and Glatopa 40 mg per mL are not interchangeable. 2.2 Instructions for Use Remove one blister-packaged pre-filled syringe from the refrigerated carton. Let the pre-filled 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 pre-filled syringe is for single use only. Discard unused portions.

• Immediate Post-Injection Reaction (flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and/or urticaria), may occur within seconds to minutes after injection and are generally transient and self-limiting ( 5.1 ) • Chest pain, usually transient ( 5.2 ) • Lipoatrophy and skin necrosis may occur. Instruct patients in proper injection technique and to rotate injection sites ( 5.3 ) • Glatopa can modify immune response ( 5.4 ) • Hepatic Injury: if signs or symptoms of hepatic dysfunction occur, consider discontinuing Glatopa ( 5.5 ) 5.1 Immediate Post-Injection Reaction Approximately 16% of patients exposed to glatiramer acetate injection 20 mg per mL in the five placebo-controlled trials compared to 4% of those on placebo, and approximately 2% of patients exposed to glatiramer acetate injection 40 mg per mL in a placebo-controlled trial compared to none on placebo, experienced a constellation of symptoms that may occur immediately (within seconds to minutes, with the majority of symptoms observed within 1 hour) after injection and included at least two of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, constriction of the throat, and urticaria. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience one or several episodes of these symptoms. Whether or not any of these symptoms actually represent a specific syndrome is uncertain.

The following serious adverse reactions are described elsewhere in the labeling: • Immediate Post-Injection Reaction [see Warnings and Precautions ( 5.1 )] • Chest Pain [see Warnings and Precautions ( 5.2 )] • Lipoatrophy and Skin Necrosis [see Warnings and Precautions ( 5.3 )] • Potential Effects on Immune Response [see Warnings and Precautions ( 5.4 )] • Hepatic Injury [see Warnings and Precautions ( 5.5 )] • In controlled studies of glatiramer acetate injection 20 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 ) • In a controlled study of glatiramer acetate injection 40 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Incidence in Controlled Clinical Trials Glatiramer Acetate Injection 20 mg per mL per day Among 563 patients treated with glatiramer acetate injection in blinded placebo-controlled trials, approximately 5% of the subjects discontinued treatment because of an adverse reaction.

8.1 Pregnancy Risk Summary Available human data on the use of Glatopa in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryo-fetal or offspring development ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data There are no adequate and well-controlled studies of Glatopa in pregnant women. The available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. Animal Data In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryo-fetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m 2 basis).

Metabolism

Results obtained in pharmacokinetic studies performed in humans (healthy volunteers) and animals support that a substantial fraction of the therapeutic dose delivered to patients subcutaneously is hydrolyzed locally. Larger fragments of glatiramer acetate can be recognized by glatiramer acetate-reactive antibodies.

• Dec 20, 1996NDANDA020622Teva Pharms Usa
• Apr 16, 2015ANDAANDA090218Sandoz
• Oct 3, 2017ANDAANDA091646Mylan
• Oct 3, 2017ANDAANDA206936Mylan
• Feb 12, 2018ANDAANDA206921Sandoz
• Sep 25, 2024ANDAANDA203857Synthon Pharms Inc
• Sep 25, 2024ANDAANDA206873Synthon Pharms Inc
• May 7, 2025ANDAANDA208468Chemi Spa

1. 1Multiple Sclerosis Relapse5,3408.6%
2. 2Injection Site Pain5,3398.6%
3. 3Drug Ineffective4,1836.8%
4. 4Injection Site Reaction3,5865.8%
5. 5Fatigue3,4185.5%
6. 6Multiple Sclerosis3,2545.3%
7. 7Dyspnoea3,0254.9%
8. 8Injection Site Erythema2,6764.3%
9. 9Fall2,6244.2%
10. 10Injection Site Mass2,2673.7%
11. 11Gait Disturbance2,1953.5%
12. 12Pain2,1323.4%
13. 13Nausea2,0283.3%
14. 14Dizziness1,9813.2%
15. 15Headache1,8843.0%

Recent PubMed references pinned to Glatiramer as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Glatiramer Acetate Therapy Induces DNA Methylation Changes in Immune Cells of Multiple Sclerosis Patients: A Pilot Study.
  International journal of molecular sciences · 2026 · Kiselev I, Kulakova O, Baturina O, et al.
  PMID 42196591DOI 10.3390/ijms27104615
• Industry Payments and Prescribing of Brand-Name Multiple Sclerosis Medications in Medicare.
  Neurology · 2026 · Patel AN, Kesselheim AS, Rome BN, et al.
  PMID 41941704DOI 10.1212/WNL.0000000000214834
• Glatiramer acetate stimulates phagocytosis and intracellular killing of Escherichia coli by macrophages and microglial cells.
  Frontiers in immunology · 2026 · Seele J, Häusler D, Heidemann R, et al.
  PMID 41878423DOI 10.3389/fimmu.2026.1761044
• Pharmacogenomics of response to interferon-beta and glatiramer acetate in Multiple Sclerosis: A multi-centric study.
  Multiple sclerosis (Houndmills, Basingstoke, England) · 2026 · Corona A, Clarelli F, Pääkkönen K, et al.
  PMID 41776383DOI 10.1177/13524585261417130
• Real-world evaluation of the transition between originator and follow-on glatiramer acetate in people with multiple sclerosis: the "GA transition" study.
  Multiple sclerosis and related disorders · 2026 · Schiavetti I, Annovazzi P, Cordioli C, et al.
  PMID 41740479DOI 10.1016/j.msard.2026.107088
• GA Depot, a long-acting glatiramer acetate, vs placebo in patients with relapsing multiple sclerosis: A randomized phase 3 clinical trial.
  Multiple sclerosis (Houndmills, Basingstoke, England) · 2026 · Miller A, Cohen JA, Karni A, et al.
  PMID 41705515DOI 10.1177/13524585251405101
• Lyophilized formulation development and characterization of stable glatiramer acetate/oligonucleotide polyplexes at clinically therapeutic strengths.
  International journal of pharmaceutics · 2026 · Gong H, Luan X, Daniel Griffin J, et al.
  PMID 41662999DOI 10.1016/j.ijpharm.2026.126659
• Anaphylaxis and glatiramer acetate.
  Multiple sclerosis (Houndmills, Basingstoke, England) · 2025 · Kim TB, Lee JY, Brinker A, et al.
  PMID 41139841DOI 10.1177/13524585251382397

The 10 most recently updated of 126 ClinicalTrials.gov registrations naming Glatiramer as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
  Active not recruiting · Observational · 1,178 enrolled · Biogen
  NCT05688436updated 2026-06-04
• A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
  Recruiting · Observational · 800 enrolled · Novartis Pharmaceuticals
  NCT05344469updated 2026-06-01
• Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS
  Terminated · Phase 2 · Interventional · 30 enrolled · Mapi Pharma Ltd.
  NCT03362294updated 2026-04-23
• Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS
  Completed · Phase 3 · Interventional · 185 enrolled · Novartis Pharmaceuticals
  NCT04788615updated 2026-03-03
• Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis
  Completed · Interventional · 77 enrolled · University Hospital, Rouen
  NCT04821596updated 2026-02-18
• Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation
  Enrolling by invitation · Interventional · 24 enrolled · University of Pennsylvania
  NCT05162638updated 2026-01-09
• A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
  Terminated · Phase 3 · Interventional · 16 enrolled · Genzyme, a Sanofi Company
  NCT03368664updated 2025-11-26
• A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
  Active not recruiting · Observational · 10,500 enrolled · Biogen
  NCT05767736updated 2025-10-16
• Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
  Active not recruiting · Interventional · 900 enrolled · Johns Hopkins University
  NCT03500328updated 2025-10-14
• A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
  Not yet recruiting · Phase 3 · Interventional · 250 enrolled · University Hospital, Montpellier
  NCT07189325updated 2025-09-23

Frequently asked questions

How does Glatiramer work?

The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS.

What is Glatiramer used for?

According to FDA labeling, Glatiramer carries indications including: Glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatopa is indicated for the treatment of relapsing-forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Glatiramer?

Glatiramer is classified as Immunologic Adjuvants, Decreased Immunologically Active Molecule Activity.

What are the brand names for Glatiramer?

Glatiramer is marketed under brand names including Copaxone, Glatopa.

What are the contraindications for Glatiramer?

Glatiramer labeling lists contraindications including: Glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.. Always consult the full prescribing information and a clinician.