Glatiramer Acetate 20 mg/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Other immunostimulants class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- It's a treatment for relapsing forms of multiple sclerosis (MS) in adults. That includes a first episode that might signal MS (called clinically isolated syndrome), the classic rel...
- What exactly is glatiramer acetate used for?
- Yes, where you inject absolutely matters. You inject under the skin — never into a vein — and you should rotate your injection sites every single time. Good spots include your uppe...
- How do I give myself the injection, and does it matter where I inject?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Glatiramer acetate — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $42.682 | $1,280.45 / 30 ml |
| Medicaid paysCMS SDUD · 12 mo | $70.07 | $2,102.00 / 30 ml |
| Medicare drug plans payPart D · Q2 2026 | $82.00 | $2,460.00 / 30 ml |
| Medicare Part B allowsASP · J1595 | No ASP payment limit on file for J1595 this quarter. | |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Glatiramer Acetate 20 mg/mLthis 00378-6960-93 | Mylan | 1 syringe | $42.682 | AP | Availability likely | — |
| Glatopa 20 mg/mL 00781-3234-34 | Sandoz | 1 syringe | $42.682 | AP | Availability likely | — |
| Glatiramer Acetate 20 mg/mL 00832-6084-30 | UPSHER-SMITH | 30 syringes | $42.682 | AP | Availability likely | — |
| Glatiramer Acetate 20 mg/mL 47335-0990-02 | Sun | 1 syringe | $42.682 | AP | Availability likely | — |
| Glatiramer Acetate 20 mg/mL 70710-1548-09 | Zydus | 1 syringe | $42.682 | AP | Availability likely | — |
| Copaxone 20 mg/mL 68546-0317-30 | Teva | 1 syringe | $229.799 | AP | Availability likely | +438% |
| Glatiramer Acetate 20 mg/mL 11797-0764-03 | Italfarmaco | 30 syringes | — | AP | FDA listed | — |
| Glatopa 20 mg/mL 63629-8815-01 | Bryant | 1 syringe | — | AP | FDA listed | — |
| Glatiramer Acetate 20 mg/mL 82983-0429-30 | AJENAT | 1 syringe | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00378-6960-93 You're viewing this | 30 BLISTER PACK in 1 CARTON (0378-6960-93) / 1 SYRINGE in 1 BLISTER PACK (0378-6960-32) / 1 mL in 1 SYRINGE | 2017-10-04 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with glatiramer acetate injection. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. • Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Prompt identification of anaphylaxis is important to avoid a delay in treatment [see Warnings and Precautions (5.1) ] . • Glatiramer acetate injection is contraindicated in patients with a history of hypersensitivity reactions to glatiramer acetate injection, including anaphylaxis.
If an anaphylactic reaction occurs, treatment with glatiramer acetate injection must be immediately discontinued. Unless a clear alternative etiology is identified, glatiramer acetate injection must be permanently discontinued [see Contraindications (4) and Warnings and Precautions (5.1) ] . WARNING: ANAPHYLACTIC REACTIONS See full prescribing information for complete boxed warning.
Life-threatening and fatal anaphylaxis, which can occur at any time following initiation of therapy (from as early as after the first dose, up to years after initiation of treatment), has been reported in patients receiving glatiramer acetate injection. • Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction. Prompt identification of anaphylaxis is important to avoid a delay in treatment ( 5.1 ). • Glatiramer acetate injection is contraindicated in patients with a history of hypersensitivity reactions to glatiramer acetate injection, including anaphylaxis ( 4 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Glatiramer acetate injection 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. Glatiramer acetate injection 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 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • For subcutaneous injection only; doses are not interchangeable ( 2.1 ) • Glatiramer acetate injection 20 mg/mL per day ( 2.1 ) • Before use, allow the solution to warm to room temperature ( 2.2 )
2.1Recommended Dose Glatiramer acetate injection is for subcutaneous use only [see Dosage and Administration (2.2) ] . Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended dose is: • Glatiramer acetate injection 20 mg per mL: administer once per day Glatiramer acetate injection 20 mg per mL and glatiramer acetate injection 40 mg per mL are not interchangeable.
2.2Instructions for Use Remove one blister-packaged prefilled syringe from the refrigerated carton. Let the prefilled 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 prefilled syringe is for single use only. Discard unused portions. Using an autoinjector that is not compatible for use with Mylan’s glatiramer acetate injection may increase the risk for medication errors, such as dose omission or administration of a partial dose [see Warnings and Precautions (5.7) ] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS • Injection: 20 mg per mL in a single-dose, prefilled syringe with a light blue plunger. For subcutaneous use only. • Injection: 20 mg/mL in a single-dose, prefilled syringe with a light blue plunger ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . Known hypersensitivity to glatiramer acetate or mannitol ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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 ( 5.2 ) • Chest pain, usually transient ( 5.3 ) • Lipoatrophy and skin necrosis may occur. Instruct patients in proper injection technique and to rotate injection sites ( 5.4 ) • Glatiramer acetate can modify immune response ( 5.5 ) • Hepatic Injury: if signs or symptoms of hepatic dysfunction occur, consider discontinuing glatiramer acetate ( 5.6 ) • Glatiramer Acetate Products and Administration Errors: Using an optional autoinjector that is not compatible for use with Mylan’s glatiramer acetate injection may increase the risk for medication errors, such as dose omission or administration of a partial dose.
( 5.7 )
5.1Anaphylactic Reactions Life-threatening and fatal anaphylaxis has been reported with glatiramer acetate injection [see Adverse Reactions (6.2) ] . Glatiramer acetate injection is contraindicated in patients with a history of hypersensitivity reactions to glatiramer acetate injection, including anaphylaxis [see Contraindications (4) ] . Anaphylaxis can occur at any time following initiation of glatiramer acetate injection therapy, from as early as after the first dose, up to years after initiation of treatment.
Anaphylaxis occurred within an hour of a glatiramer acetate injection in most of the reported cases. Some signs and symptoms of anaphylactic reactions may overlap with those of immediate post-injection reactions [see Warnings and Precautions (5.2) ] . All patients receiving treatment with glatiramer acetate injection and caregivers should be informed about the signs and symptoms of anaphylactic reactions, and that they must seek immediate emergency medical care in case of experiencing such symptoms.
If an anaphylactic reaction occurs, treatment with glatiramer acetate injection must be immediately discontinued. Unless a clear alternative etiology is identified, glatiramer acetate injection must be permanently discontinued [see Contraindications (4) ] .
5.2Immediate Post-Injection Reaction Approximately 16% of patients exposed to glatiramer acetate injection 20 mg per mL in the 5 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.
These events are termed immediate post-injection reactions. The symptoms of an immediate post-injection reaction may overlap with those of anaphylaxis; prompt identification of anaphylaxis is important to avoid a delay in treatment. In general, symptoms of an immediate post-injection reaction have 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. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who developed fatal anaphylaxis and/or received emergency medical care . Whether an immunologic or nonimmunologic mechanism mediates these episodes, or whether several similar episodes seen in a given patient have identical mechanisms, is unknown.
5.3Chest Pain Approximately 13% of glatiramer acetate injection 20 mg per mL patients in the 5 placebo-controlled studies compared to 6% of placebo patients, and approximately 2% of patients exposed to glatir…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Anaphylactic Reactions [see Warnings and Precautions (5.1) ] • Immediate Post-Injection Reaction [see Warnings and Precautions (5.2) ] • Chest Pain [see Warnings and Precautions (5.3) ] • Lipoatrophy and Skin Necrosis [see Warnings and Precautions (5.4) ] • Potential Effects on Immune Response [see Warnings and Precautions (5.5) ] • Hepatic Injury [see Warnings and Precautions (5.6) ] • 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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.
The adverse reactions most commonly associated with discontinuation were: injection site reactions, dyspnea, urticaria, vasodilatation, and hypersensitivity. The most common adverse reactions were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain. Table 1 lists signs and symptoms that occurred in at least 2% of patients treated with glatiramer acetate injection 20 mg per mL in the placebo-controlled trials.
These signs and symptoms were numerically more common in patients treated with glatiramer acetate injection than in patients treated with placebo. Adverse reactions were usually mild in intensity. Table 1: Adverse Reactions in Controlled Clinical Trials with an Incidence ≥ 2% of Patients and More Frequent with Glatiramer Acetate Injection (20 mg per mL Daily) than with Placebo Glatiramer Acetate Injection 20 mg/mL (n = 563) % Placebo (n = 564) % Blood and Lymphatic System Disorders Lymphadenopathy 7 3 Cardiac Disorders Palpitations 9 4 Tachycardia 5 2 Eye Disorders Eye Disorder 3 1 Diplopia 3 2 Gastrointestinal Disorders Nausea 15 11 Vomiting 7 4 Dysphagia 2 1 General Disorders and Administration Site Conditions Injection Site Erythema 43 10 Injection Site Pain 40 20 Injection Site Pruritus 27 4 Injection Site Mass 26 6 Asthenia 22 21 Pain 20 17 Injection Site Edema 19 4 Chest Pain 13 6 Injection Site Inflammation 9 1 Edema 8 2 Injection Site Reaction 8 1 Pyrexia 6 5 Injection Site Hypersensitivity 4 0 Local Reaction 3 1 Chills 3 1 Face Edema 3 1 Edema Peripheral 3 2 Injection Site Fibrosis 2 1 Injection Site Atrophy Injection site atrophy comprises terms relating to localized lipoatrophy at injection site 2 0 Immune System Disorders Hypersensitivity 3 2 Infections and Infestations Infection 30 28 Influenza 14 13 Rhinitis 7 5 Bronchitis 6 5 Gastroenteritis 6 4 Vaginal Candidiasis 4 2 Metabolism and Nutrition Disorders Weight Increased 3 1 Musculoskeletal and Connective Tissue Disorders Back Pain 12 10 Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) Benign Neoplasm of Skin 2 1 Nervous System Disorders Tremor 4 2 Migraine 4 2 Syncope 3 2 Speech Disorder 2 1 Psychiatric Disorders Anxiety 13 10 Nervousness 2 1 Renal and Urinary Disorders Micturition Urgency 5 4 Respiratory, Thoracic and Mediastinal Disorders Dyspnea 14 4 Cough 6 5 Laryngospasm 2 1 Skin and Subcutaneous Tissue Disorders Rash 19 11 Hyperhidrosis…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes ( see Data ). Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other outcomes. 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 Data from pharmacovigilance and published observational studies have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes when glatiramer acetate was used during pregnancy.
However, the published comparative observational studies have methodological limitations, such as short exposure duration during pregnancy, confounding, selection bias, and exposure misclassification. Animal Data In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryofetal 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). In rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed.
8.2Lactation Risk Summary There are no data on the presence of glatiramer acetate in human milk. Based on the low systemic exposure because of substantial local hydrolysis of glatiramer acetate following subcutaneous administration, breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug [see Clinical Pharmacology (12.3) ] . There are no data on the effects of glatiramer acetate on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatiramer acetate injection and any potential adverse effects on the breastfed infant from glatiramer acetate injection or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age.
8.5Geriatric Use Glatiramer acetate injection has not been studied in elderly patients.
8.6Use in Patients with Impaired Renal Function The pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes ( see Data ). Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other outcomes. 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 Data from pharmacovigilance and published observational studies have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes when glatiramer acetate was used during pregnancy.
However, the published comparative observational studies have methodological limitations, such as short exposure duration during pregnancy, confounding, selection bias, and exposure misclassification. Animal Data In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryofetal 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). In rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use Glatiramer acetate injection has not been studied in elderly patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis, a condition induced in animals through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS.
Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. Because glatiramer acetate can modify immune functions, concerns exist about its potential to alter naturally-occurring immune responses. There is no evidence that glatiramer acetate does this, but this has not been systematically evaluated [see Warnings and Precautions (5.5) ] .
12.3Pharmacokinetics 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. Some fraction of the injected material, either intact or partially hydrolyzed, is presumed to enter the lymphatic circulation, enabling it to reach regional lymph nodes, and some may enter the systemic circulation intact.
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis, a condition induced in animals through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS.
Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. Because glatiramer acetate can modify immune functions, concerns exist about its potential to alter naturally-occurring immune responses. There is no evidence that glatiramer acetate does this, but this has not been systematically evaluated [see Warnings and Precautions (5.5) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Glatiramer Acetate Injection is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution in a 1 mL single-dose, prefilled syringe with fixed ½ inch 29 gauge needle supplied as: • 20 mg/mL in a single-dose, prefilled syringe with a light blue plunger, in individual blister packages supplied in 30-count cartons (NDC 0378-6960-93). Some glatiramer acetate products can be administered by an optional compatible autoinjector. Compatible autoinjectors are supplied separately if available, but the availability of compatible autoinjectors may change with time [see Warnings and Precautions (5.7) and Patient Counseling Information (17) ] .
Store glatiramer acetate injection refrigerated at 2° to 8°C (36° to 46°F). If needed, the patient may store glatiramer acetate injection at room temperature, 15° to 30°C (59° to 86°F), for up to one month, but refrigeration is preferred. Avoid exposure to higher temperatures or intense light.
Do not freeze glatiramer acetate injection. If a glatiramer acetate syringe freezes, it should be discarded. PHARMACIST: Dispense a Medication Guide with each prescription.
📋 Description ▾
11 DESCRIPTION Glatiramer acetate, the active ingredient of glatiramer acetate injection, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies.
Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is: (Glu, Ala, Lys, Tyr) x ● x CH 3 COOH (C 5 H 9 NO 4 ● C 3 H 7 NO 2 ● C 6 H 14 N 2 O 2 ● C 9 H 11 NO 3 ) x ● x C 2 H 4 O 2 CAS - 147245-92-9 Glatiramer acetate is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of glatiramer acetate solution contains 20 mg of glatiramer acetate and the following inactive ingredient: 40 mg of mannitol.
The pH of the solutions is approximately 5.5 to 7.0. The biological activity of glatiramer acetate is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Important Administration Instructions Advise patients with new or existing glatiramer acetate prescriptions to consult their pharmacist or healthcare provider if they would like information about using an optional compatible autoinjector device, if available. Additionally, advise patients who would like to use an autoinjector for administration, should one be available, that not all available autoinjectors are compatible with all glatiramer acetate products and the availability of compatible autoinjectors may change with time.
If you have questions about the availability or compatibility of an autoinjector, contact the manufacturer of the prescribed glatiramer acetate product for more information. Advise patients that using an optional autoinjector that is not compatible with the glatiramer acetate product may increase the risk for medication errors, such as missing a dose or administration of a partial dose [see Dosage and Administration (2.2) , Warnings and Precautions (5.7) ] . Anaphylactic Reactions Advise patients and their caregivers that glatiramer acetate injection may cause life-threatening and fatal anaphylactic reactions shortly after injection, and that reactions may occur months to years after initiation of treatment [see Warnings and Precautions (5.1) ] .
Inform patients and their caregivers about the signs and symptoms specific for anaphylactic reactions, and that signs and symptoms of anaphylactic reactions may overlap with those of immediate post-injection reactions. Instruct them to seek immediate emergency medical care if they experience any signs or symptoms of an anaphylactic reaction [see Warnings and Precautions (5.1 , 5.2) ] . Patients should be advised to also contact their healthcare provider, and that treatment should be discontinued immediately and permanently if anaphylactic reactions occur.
Immediate Post-Injection Reaction Advise patients that glatiramer acetate may cause immediate post-injection reactions, characterized by various symptoms after injection, including flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, constriction of the throat, and urticaria [see Warnings and Precautions (5.2) ] . These symptoms occur within seconds to minutes after injection and are generally transient, self-limited, and do not require specific treatment. Inform patients that these symptoms may occur early or may have their onset several months after the initiation of treatment.
A patient may experience one or several episodes of these symptoms. Advise patients that the symptoms of an immediate post-injection reaction may overlap with those of an anaphylactic reaction. Advise patients to contact their healthcare provider if they experience any signs or symptoms of an immediate post-injection reaction [see Warnings and Precautions (5.1 , 5.2) ] .
Chest Pain Advise patients that they may experience transient chest pain either as part of the Immediate Post-Injection Reaction or in isolation [see Warnings and Precautions (5.3) ] . Inform patients that the pain should be transient. Some patients may experience more than one such episode, usually beginning at least one month after the initiation of treatment.
Patients should be advised to seek medical attention if they experience chest pain of unusual duration or intensity. Lipoatrophy and Skin Necrosis at Injection Site Advise patients that localized lipoatrophy, and rarely, skin necrosis may occur at injection sites [see Warnings and Precautions (5.4) ] . Instruct patients to follow proper injection technique and to rotate injection areas and sites with each injection to minimize these risks.
Hepatic Injury Advise patients that hepatic injury, including hepatic failure and hepatitis with jaundice, has been reported with the use of glatiramer acetate injection. Educate patients about the signs and symptoms of he…
💬 Medication Guide ▾
Medication Guide Glatiramer Acetate Injection (gla tir′ a mer as′ e tate) for subcutaneous use Read this Medication Guide before you start using glatiramer acetate injection and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about glatiramer acetate injection? • Serious allergic reactions (anaphylactic reactions). Serious allergic reactions that may be life-threatening or lead to death may happen any time after you start using glatiramer acetate injection. These reactions may happen right after your first dose up to years after starting treatment with glatiramer acetate injection, even if you never had an allergic reaction before.
Many reactions have happened within 1 hour of using glatiramer acetate injection. Some signs and symptoms may be the same as those of an immediate post-injection reaction. See What are the possible side effects of glatiramer acetate injection?
Stop using glatiramer acetate injection and get emergency help right away if you have: o widespread rash o swelling of the face, eyelids, lips, mouth, throat, or tongue o sudden shortness of breath, difficulty breathing, or wheezing o uncontrolled shaking (convulsions) o trouble swallowing or speaking o fainting, feeling dizzy or faint What is glatiramer acetate injection? Glatiramer acetate injection is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
It is not known if glatiramer acetate injection is safe and effective in children under 18 years of age. Do not take glatiramer acetate injection: • if you are allergic to glatiramer acetate or mannitol. Serious allergic reactions including life-threatening or anaphylactic reactions that can lead to death have happened.
See the end of this leaflet for a complete list of the ingredients in glatiramer acetate injection. Before you use glatiramer acetate injection, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. Talk to your healthcare provider who will advise if you should take glatiramer acetate injection during your pregnancy. • are breastfeeding or plan to breastfeed.
It is not known if glatiramer acetate passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using glatiramer acetate injection. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Glatiramer acetate injection may affect the way other medicines work, and other medicines may affect how glatiramer acetate injection works. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.
How should I use glatiramer acetate injection? • For detailed instructions, see the Instructions for Use at the end of this leaflet for complete information on how to use glatiramer acetate injection. • Your healthcare provider will tell you how much glatiramer acetate injection to use and when to use it. • Glatiramer acetate injection is given by injection under your skin (subcutaneously). • Use glatiramer acetate injection exactly as your healthcare provider tells you to use it. • Since every body type is different, talk with your healthcare provider about the injection areas that are best for you. • You should receive your first dose of glatiramer acetate injection with a healthcare provider or nurse present.
This might be at your healthcare provider’s office or with a visiting home health nurse who will teach you how to give your glatiramer acetate injections. • Some glatiramer acetate products can be used…