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Glatiramer acetate: Drug information

Glatiramer acetate: Drug information
(For additional information see "Glatiramer acetate: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Copaxone;
  • Glatopa
Brand Names: Canada
  • Copaxone;
  • Glatect
Pharmacologic Category
  • Biological, Miscellaneous
Dosing: Adult

Note: Safety: In high-risk populations or in countries with high tuberculosis burden, screen for latent infections (eg, hepatitis, tuberculosis) prior to initiating therapy. For patients who screen positive for latent infections, consult infectious disease or other appropriate specialists (eg, liver specialists) regarding treatment options before initiating therapy (Ref). Dosage forms: Glatiramer 20 mg/mL and 40 mg/mL formulations are not interchangeable.

Multiple sclerosis, relapsing

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: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions were generally less common in trials with patients treated with 40 mg per mL three times per week than in trials with patients treated with 20 mg per mL per day.

>10%:

Cardiovascular: Chest pain (2% to 13%), vasodilation (3% to 20%)

Dermatologic: Skin rash (2% to 19%)

Gastrointestinal: Nausea (2% to 15%)

Hypersensitivity: Type I hypersensitivity reaction (2% to 16%; postinjection)

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

Infection: Infection (30%), influenza (14%)

Local: Erythema at injection site (22% to 43%), itching at injection site (6% to 27%), pain at injection site (10% to 40%), residual mass at injection site (6% to 26%), swelling at injection site (6% to 19%)

Nervous system: Anxiety (13%), pain (20%)

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

Respiratory: Dyspnea (3% to 14%), nasopharyngitis (11%)

1% to 10%:

Cardiovascular: Edema (8%), facial edema (3%), palpitations (9%), peripheral edema (3%), syncope (3%), tachycardia (5%)

Dermatologic: Erythema of skin (2%), hyperhidrosis (7%), pruritus (5%), urticaria (3%)

Endocrine & metabolic: Weight gain (3%)

Gastrointestinal: Dysphagia (2%), gastroenteritis (6%), vomiting (7%)

Genitourinary: Urinary urgency (5%), vulvovaginal candidiasis (4%)

Hematologic & oncologic: Benign skin neoplasm (2%), lymphadenopathy (7%)

Hypersensitivity: Hypersensitivity reaction (3%)

Local: Atrophy at injection site (≤2%), fibrosis at injection site (2%), hypersensitivity reaction at injection site (4%), inflammation at injection site (2% to 9%), lipoatrophy at injection site (≤2%)

Nervous system: Chills (2% to 3%), migraine (4%), nervousness (2%), speech disturbance (2%)

Neuromuscular & skeletal: Laryngospasm (2%), tremor (4%)

Ophthalmic: Diplopia (3%)

Respiratory: Bronchitis (6%), cough (6%), flu-like symptoms (3%), rhinitis (7%), viral respiratory tract infection (3%)

Miscellaneous: Fever (3% to 6%)

<1%:

Hematologic & oncologic: Thrombocytopenia

Infection: Herpes simplex infection

Neuromuscular & skeletal: Arthralgia

Postmarketing:

Cardiovascular: Acute myocardial infarction, angina pectoris, cardiac arrhythmia, cardiac failure, cardiomegaly, cardiomyopathy, cerebrovascular accident, coronary occlusion, deep vein thrombophlebitis, pericardial effusion, peripheral vascular disease, pulmonary embolism, thrombosis

Endocrine & metabolic: Hypercholesterolemia

Gastrointestinal: Cholelithiasis, enlargement of abdomen, eructation, gastrointestinal hemorrhage, gastrointestinal ulcer

Genitourinary: Nephrosis, urinary frequency

Hematologic & oncologic: Acute leukemia, bladder carcinoma, breast carcinoma, CNS neoplasm, genitourinary neoplasm, lung carcinoma, ovarian carcinoma, pseudolymphoma

Hepatic: Hepatic cirrhosis, hepatic failure, hepatic injury, hepatitis, jaundice

Hypersensitivity: Nonimmune anaphylaxis, tongue edema

Infection: Sepsis

Local: Tissue necrosis at injection site

Nervous system: Abnormal dreams, aphasia, brain edema, hydrocephalus, meningitis, neuralgia, seizure

Neuromuscular & skeletal: Muscle spasm, myelitis, rheumatoid arthritis, systemic lupus erythematosus

Ophthalmic: Glaucoma

Renal: Renal failure syndrome

Respiratory: Pleural effusion

Contraindications

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

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.

• Infections: In high-risk populations or in countries with high tuberculosis burden, screen for latent infections (eg, hepatitis, tuberculosis) prior to initiating therapy. For patients who screen positive for latent infections, consult infectious disease or other specialists (eg, liver specialists) regarding treatment options before initiating therapy (AAN [Farez 2019]).

• 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.

• Immunizations: Avoid live-attenuated vaccines in patients who currently receive or have recently discontinued glatiramer acetate; consider using live-attenuated vaccines only if risk of infection is high and killed vaccines are unavailable (AAN [Farez 2019]).

• Medication errors: Administering glatiramer acetate products with incompatible autoinjectors may cause medication errors (eg, partial dose, dose omission); not all glatiramer acetate products have marketed optional compatible autoinjectors. Prior to using an optional autoinjector, ensure the device is compatible for use with the specific glatiramer acetate product by referring to autoinjector labeling; availability of compatible autoinjectors may change over time.

Dosage Forms: US

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)

Generic Equivalent Available: US

Yes

Pricing: US

Solution Prefilled Syringe (Copaxone Subcutaneous)

20 mg/mL (per mL): $284.56

40 mg/mL (per mL): $583.20

Solution Prefilled Syringe (Glatiramer Acetate Subcutaneous)

20 mg/mL (per mL): $216.41

40 mg/mL (per mL): $524.30

Solution Prefilled Syringe (Glatopa Subcutaneous)

20 mg/mL (per mL): $216.41

40 mg/mL (per mL): $524.30

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Solution Prefilled Syringe, Subcutaneous:

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

Glatect: 20 mg/mL (1 mL)

Administration: Adult

SUBQ: For SUBQ administration in the arms, abdomen, hips, or thighs using prefilled syringe or an optional compatible injection device; 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. If using an optional autoinjector, ensure device is compatible with Copaxone or Glatopa; using a noncompatible device may increase the risk of medication errors; refer to autoinjector instructions for additional details.

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.

Medication Safety Issues
Sound-alike/look-alike issues:

Copaxone may be confused with Compazine

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

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 patients planning to become pregnant (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

Outcome data following maternal use of glatiramer acetate in pregnancy are available (Fragoso 2014; Herbstritt 2016; Kaplan 2022; 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]).

Breastfeeding Considerations

It is not known if glatiramer acetate is present in breast milk.

Outcome data following use of glatiramer acetate in lactating patients are available (Ines Ciplea 2022; Kaplan 2022).

Breastfeeding is not expected to provide clinically relevant exposure to an infant via breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Based on its chemical properties, others consider glatiramer acetate compatible with breastfeeding (Almas 2016; Dobson 2019; Fragoso 2018).

Monitoring Parameters

Latent infection screening (eg, hepatitis, tuberculosis) in high-risk populations or in countries with high tuberculosis burden (baseline).

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Small amounts of intact and partial hydrolyzed drug enter lymphatic circulation.

Metabolism: SUBQ: Large percentage hydrolyzed locally.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Galtipex;
  • (AR) Argentina: Copaxone | Escadra | Polimunol;
  • (AT) Austria: Copaxone | Perscleran;
  • (AU) Australia: Copaxone | Glatira | Glatiramer acetate teva;
  • (BE) Belgium: Copaxone | Glataxon | Glatiramyl;
  • (BG) Bulgaria: Copaxone | Remurel;
  • (BR) Brazil: Copaxone;
  • (CH) Switzerland: Copaxone | Glatiramyl;
  • (CL) Chile: Copaxone;
  • (CO) Colombia: Autix | Copaxone | Glamatir | Glatir | Glystral;
  • (CZ) Czech Republic: Copaxone | Remurel;
  • (DE) Germany: Clift | Copaxone | Glatirameracetate abz;
  • (DO) Dominican Republic: Probioglat;
  • (EE) Estonia: Copaxone | Remurel | Remurel zentiva;
  • (ES) Spain: Copaxone | Glatiramero mylan;
  • (FI) Finland: Copaxone | Glatimyl;
  • (FR) France: Copaxone | Glatiramer mylan;
  • (GB) United Kingdom: Brabio | Copaxone;
  • (GR) Greece: Clift | Copaxone | Glatiramer/mylan;
  • (HR) Croatia: Copaxone | Glatirameracetat Pliva | Remurel;
  • (HU) Hungary: Copaxone | Remurel;
  • (IE) Ireland: Brabio | Copaxone;
  • (IN) India: Glatira;
  • (IT) Italy: Copaxone | Copemyl | Copemyltri;
  • (JP) Japan: Copaxone;
  • (KR) Korea, Republic of: Copaxone;
  • (KW) Kuwait: Galtipex;
  • (LT) Lithuania: Copaxone | Remurel;
  • (LU) Luxembourg: Copaxone;
  • (LV) Latvia: Copaxone | Remurel;
  • (MX) Mexico: Copaxone | Doxelev | Linator | Prig | Probioglat | Tlenec;
  • (NL) Netherlands: Copaxone | Glatirameeracetat;
  • (NO) Norway: Copaxone | Copemyl;
  • (NZ) New Zealand: Copaxone;
  • (PE) Peru: Copaxone;
  • (PL) Poland: Remurel;
  • (PR) Puerto Rico: Copaxone | Glatopa;
  • (PT) Portugal: Acetato de glatiramero mylan | Clift | Copaxone;
  • (PY) Paraguay: Copaxone | Glamatir | Glatiramer libra;
  • (RO) Romania: Copaxone | Remurel;
  • (RU) Russian Federation: Aksoglatiran fs | Copaxone | Copaxone teva | Glatirat | Timexon;
  • (SA) Saudi Arabia: Glatiject | Glitaxon;
  • (SE) Sweden: Copaxone;
  • (SI) Slovenia: Copaxone;
  • (SK) Slovakia: Copaxone | Remurel;
  • (TN) Tunisia: Glitaxon;
  • (TW) Taiwan: Copaxone;
  • (UA) Ukraine: Copaxone | Glatiramer acetat-vista
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