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Glatiramer Acetate

Medically reviewed by Drugs.com. Last updated on Jul 4, 2020.

Pronunciation

(gla TIR a mer AS e tate)

Index Terms

  • Copolymer-1

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous:

Copaxone: 20 mg/mL (1 mL); 40 mg/mL (1 mL)

Glatopa: 20 mg/mL (1 mL) [contains mannitol]

Glatopa: 40 mg/mL (1 mL)

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Generic: 20 mg/mL (1 mL); 40 mg/mL (1 mL)

Brand Names: U.S.

  • Copaxone
  • Glatopa

Pharmacologic Category

  • Biological, Miscellaneous

Pharmacology

Glatiramer is a mixture of random polymers of four amino acids; L-alanine, L-glutamic acid, L-lysine, and L-tyrosine, the resulting mixture is antigenically similar to myelin basic protein, which is an important component of the myelin sheath of nerves; glatiramer is thought to induce and activate T-lymphocyte suppressor cells specific for a myelin antigen, it is also proposed that glatiramer interferes with the antigen-presenting function of certain immune cells opposing pathogenic T-cell function

Distribution

A small percentage of intact and partial hydrolyzed drug is presumed to enter lymphatic circulation.

Metabolism

SubQ: Large percentage hydrolyzed locally

Use: Labeled Indications

Multiple sclerosis, relapsing: Treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Contraindications

Hypersensitivity to glatiramer acetate, mannitol, or any component of the formulation

Dosing: Adult

Note:Glatiramer 20 mg/mL and 40 mg/mL formulations are not interchangeable.

Multiple sclerosis, relapsing: SubQ: 20 mg once daily or 40 mg 3 times per week administered at least 48 hours apart.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Administration

SubQ: For SubQ administration in the arms, abdomen, hips, or thighs; rotate injection sites to possibly minimize the occurrence of lipoatrophy. Do not administer IV. Administer the 40 mg dose on the same 3 days each week (eg, Monday, Wednesday, Friday) at least 48 hours apart. Allow syringe to stand at room temperature for 20 minutes prior to injection. Discard unused portions.

Storage

Store at 2°C to 8°C (36°F to 46°F). If needed, may store at 15°C to 30°C (59°F to 86°F) for up to 1 month (refrigeration is preferred). Avoid exposure to high temperatures; protect from intense light. Do not freeze. Discard if syringe freezes.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Cardiovascular: Vasodilation (3% to 20%), chest pain (2% to 13%)

Central nervous system: Pain (20%), anxiety (13%)

Dermatologic: Skin rash (2% to 19%), diaphoresis (15%)

Gastrointestinal: Nausea (2% to 15%)

Hypersensitivity: Immediate hypersensitivity (2% to 16%; postinjection, including flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria)

Immunologic: Development of IgG antibodies (3 months: ≥3 x baseline: 80%; 12 months: 90%; ≥3 x baseline: 30%)

Infection: Infection (30%)

Local: Inflammation at injection site (2% to 49%), erythema at injection site (22% to 43%), pain at injection site (10% to 40%), itching at injection site (6% to 27%), residual mass at injection site (6% to 27%), swelling (1% to 19%)

Neuromuscular & skeletal: Weakness (22%), back pain (12%)

Respiratory: Dyspnea (3% to 14%), flu-like symptoms (3% to 14%), nasopharyngitis (11%)

1% to 10%:

Cardiovascular: Palpitations (7% to 9%), edema (8%), tachycardia (5%), facial edema (3%), peripheral edema (3%), syncope (3%), hypertension (1%)

Central nervous system: Migraine (4%), chills (2% to 3%), nervousness (2%), speech disturbance (2%), abnormal dreams (1%), emotional lability (1%), stupor (1%)

Dermatologic: Hyperhidrosis (7%), pruritus (5%), erythema (2% to 4%), urticaria (3%), skin atrophy (≥1%), warts (≥1%), eczema (1%), pustular rash (1%)

Endocrine & metabolic: Weight gain (3%), amenorrhea (1%), hypermenorrhea (1%)

Gastrointestinal: Vomiting (7%), gastroenteritis (6%), dysphagia (2%), aphthous stomatitis (≥1%), bowel urgency (≥1%), dental caries (≥1%), enlargement of salivary glands (≥1%), oral candidiasis (≥1%)

Genitourinary: Urinary urgency (5%), vulvovaginal candidiasis (4%), abnormal Pap smear (≥1%), hematuria (≥1%), vaginal hemorrhage (≥1%), impotence (1%)

Hematologic & oncologic: Bruise (8%), lymphadenopathy (7%), benign skin neoplasm (2%)

Hypersensitivity: Hypersensitivity (3%)

Infection: Abscess (≥1%), herpes zoster (≥1%)

Local: Bleeding at injection site (5%), hypersensitivity reaction at injection site (4%), fibrosis at injection site (2%), lipoatrophy at injection site (≤2%), abscess at injection site (1%)

Neuromuscular & skeletal: Neck pain (8%), tremor (4%), laryngospasm (2%)

Ophthalmic: Diplopia (3%), visual field defect (1%)

Respiratory: Rhinitis (7%), bronchitis (6%), cough (6%), laryngismus (5%), viral respiratory tract infection (3%), hyperventilation (1%)

Miscellaneous: Fever (3% to 6%)

<1%, postmarketing, and/or case reports (Limited to important or life-threatening): Amyotrophy, anaphylactoid reaction, anemia, angina pectoris, angioedema, aphasia, arthritis, asthma, ataxia, atrial fibrillation, blepharoptosis, blindness, bradycardia, bursitis, carcinoma (breast, bladder, lung, ovarian), cardiac arrhythmia, cardiac failure, cardiomegaly, cardiomyopathy, cataract, cerebral edema, cerebrovascular accident, cholecystitis, cholelithiasis, CNS neoplasm, colitis, coma, corneal ulcer, coronary occlusion, Cushing's syndrome, cyanosis, decreased libido, deep vein thrombophlebitis, depersonalization, dermatitis, dry eye syndrome, duodenal ulcer, eosinophilia, erythema nodosum, esophageal ulcer, esophagitis, facial paralysis, fibrocystic breast disease, fourth heart sound, fungal dermatitis, furunculosis, gastrointestinal carcinoma, gastrointestinal hemorrhage, gastrointestinal ulcer, genitourinary neoplasm, glaucoma, gout, hallucination, hematemesis, hepatic cirrhosis, hepatitis, hepatomegaly, hernia, hydrocephalus, hypercholesterolemia, hyperthyroidism, hypokinesia, hypotension, hypothyroidism, hypoventilation, increased appetite, leukemia, leukopenia, lupus erythematosus, lymphedema, maculopapular rash, malignant neoplasm of cervix, malignant neoplasm of skin, mania, memory impairment, meningitis, mitral valve prolapse syndrome, moon face, muscle spasm, mydriasis, myelitis, myocardial infarction, myoclonus, nephrolithiasis, nephrosis, neuralgia, optic neuritis, oral mucosa ulcer, orthostatic hypotension, osteomyelitis, otitis externa, ovarian cyst, pancreatitis, pancytopenia, paraplegia, pericardial effusion, peripheral vascular disease, photophobia, pneumonia, priapism, pseudolymphoma, psoriasis, psychotic depression, pulmonary embolism, pyelonephritis, rectal hemorrhage, renal failure, seizures, sepsis, serum sickness, skin hypertrophy, skin photosensitivity, skin pigmentation, splenomegaly, stomatitis, suicidal tendencies, systemic lupus erythematosus, systolic heart murmur, tenosynovitis, thrombocytopenia, thrombophlebitis, thrombosis, tissue necrosis at injection site, urethritis, vesicobullous rash, weight loss, xeroderma

Warnings/Precautions

Concerns related to adverse effects:

• Chest pain: May or may not occur with the immediate postinjection reaction; described as a transient pain usually resolving in a few minutes; often unassociated with other symptoms. Episodes usually begin ≥1 month after initiation of treatment.

• Hepatic toxicity: Liver failure and hepatitis with jaundice (sometimes severe) have occurred from days to years after initiation of therapy; consider discontinuation of therapy if signs and symptoms occur.

• Hypersensitivity reactions: Anaphylactoid reactions (rare) have been reported.

• Immune response: Although there has not been a systematic evaluation of glatiramer’s potential to affect other immune functions, it may interfere with recognition of foreign antigens undermining the body's tumor surveillance and defense system against infection.

• Lipoatrophy: May occur locally at injection site at various times after treatment (sometimes after several months) and may not resolve; to possibly minimize occurrence, advise patients to follow proper injection technique and rotate site with each injection. Skin necrosis has also been observed.

• Systemic reactions: Postinjection systemic reactions may occur immediately (within seconds to minutes of injection; majority of reactions observed within 1 hour) and in a substantial percentage of patients (~16% [20 mg/mL] and ~2% [40 mg/mL] in studies); symptoms (anxiety, chest pain, constriction of the throat, dyspnea, flushing, palpitations, tachycardia, urticaria) are usually self-limited and transient. These symptoms generally occur several months after initiation of treatment.

Other warnings/precautions:

• Antigenic: Glatiramer acetate is antigenic and may possibly lead to the induction of untoward host responses. Glatiramer acetate-reactive antibodies (IgG subtype) form in most patients.

Reproductive Considerations

In general, disease-modifying therapies for multiple sclerosis (MS) are stopped prior to a planned pregnancy, except in females at high risk of MS activity (AAN [Rae-Grant 2018]). When disease-modifying therapy is needed in females planning a pregnancy (eg, high risk of disease reactivation), glatiramer acetate may be considered until pregnancy is confirmed. Delaying pregnancy is recommended for females with persistent high disease activity (ECTRIMS/EAN [Montalban 2018]).

Pregnancy Considerations

Information related to the use of glatiramer acetate in pregnancy is available (Fragoso 2014; Herbstritt 2016; MacDonald 2019; Nguyen 2019; Sandberg-Wollheim 2018).

In general, disease-modifying therapies for multiple sclerosis (MS) are not initiated during pregnancy, except in females at high risk of MS activity (AAN [Rae-Grant 2018]). When disease-modifying therapy is needed in females planning a pregnancy (eg, high risk of disease reactivation), glatiramer acetate may be considered until pregnancy is confirmed, and in select cases (eg, women with active disease), use may be continued during pregnancy (ECTRIMS/EAN [Montalban 2018]).

Patient Education

What is this drug used for?

• It is used to lower the number of setbacks with MS (multiple sclerosis).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nausea

• Vomiting

• Loss of strength and energy

• Back pain

• Injection site irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Chest pain

• Fast heartbeat

• Passing out

• Abnormal heartbeat

• Flushing

• Anxiety

• Sweating a lot

• Dizziness

• Shortness of breath

• Swollen glands

• Injection site pain, skin discoloration, temperature change, or dent

• Swelling

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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