Section 04 · Monograph

Glatiramer acetate

Reviewed Nov 2026FDA label

CopaxoneImmunomodulator

Black Box Warning

WARNING: ANAPHYLACTIC REACTIONS — Life-threatening and fatal anaphylaxis has been reported with Copaxone. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose up to years after initiation of treatment

Treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive diseaseFDA-labeled

The mechanism(s) by which glatiramer acetate exerts its effects in MS patients are not fully understood, per FDA labeling
Glatiramer acetate is thought to act by modifying immune processes believed to be responsible for the pathogenesis of MS; this is supported by studies of experimental autoimmune encephalomyelitis (EAE), an animal model of MS
Animal and in vitro studies suggest that, upon administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery
Because glatiramer acetate can modify immune function, there is a theoretical concern about altering naturally occurring immune responses; the FDA label notes there is no evidence this occurs, but it has not been systematically evaluated

Two non-interchangeable subcutaneous regimens are available: 20 mg/mL given once daily, or 40 mg/mL given three times weekly with injections at least 48 hours apart
Allow prefilled syringe/autoinjector to reach room temperature (approximately 20 minutes) before injecting
Inspect solution for particulate matter or discoloration before use; rotate injection sites (abdomen, arms, hips, thighs) with each dose
First injection should be administered under the supervision of a healthcare provider, with the patient observed for at least 30 minutes afterward given risk of immediate post-injection reaction/anaphylaxis
Only autoinjectors specifically validated/compatible with the Copaxone prefilled syringe should be used, to avoid dosing errors

No specific drug-drug interactions are documented in the Copaxone prescribing information

Anaphylaxis — life-threatening and fatal cases reported (see boxed warning); can occur at any point during treatment
Immediate post-injection reaction — flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, or urticaria within seconds to minutes of injection; reported in approximately 16% of patients on the 20 mg/mL daily regimen
Chest pain — may occur as an isolated symptom, transient, unrelated to cardiac disease, but must be distinguished from cardiac etiology
Injection site reactions — erythema (43%), pain (40%), pruritus (27%) with 20 mg/mL daily dosing; lower rates with 40 mg/mL TIW regimen (22% erythema, 10% pain)
Lipoatrophy (localized loss of fat tissue, ~2% at 20 mg/mL) and rare skin necrosis at injection sites
Vasodilatation (20%), rash (19%), dyspnea (14%), nausea (15%)
Hepatic injury, including rare cases of hepatitis and liver failure
Glatiramer acetate-reactive antibodies form in most patients; clinical significance of this immune response is not established

Observe patients for at least 30 minutes after the first injection for signs of anaphylaxis or immediate post-injection reaction
Monitor for chest pain and distinguish from cardiac causes as clinically indicated
Periodic assessment of injection sites for lipoatrophy, necrosis, or persistent skin changes
Monitor liver function periodically and assess for signs/symptoms of hepatic dysfunction
Educate patients on recognizing anaphylaxis symptoms and to seek immediate medical care if they occur, given the reaction can develop at any time during therapy

Pregnancy: available data have not identified a drug-associated risk of major birth defects; administration to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development
Lactation: low systemic maternal exposure suggests minimal exposure to a breastfed infant; developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for Copaxone and any potential adverse effects on the infant
Pediatric use: safety and effectiveness not established in patients under 18 years
Renal impairment: pharmacokinetics not specifically determined in patients with renal impairment