Glatiramer Acetate 40 mg/mL Injection, Solution — NDC 82983-430-12 (Billing 82983-0430-12)
This is a package of Glatiramer Acetate 40 mg/mL Injection, Solution from AJENAT PHARMACEUTICALS LLC, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 82983-430-12 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 82983 labeler · 430 product · 12 package
- Package marketed since
- Mar 20, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0382983430129, 0382983430013
- FDA record last changed
- Sep 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1487361
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Other immunostimulants class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Glatiramer injection is used to treat various forms of multiple sclerosis (MS; a disease that damages nerves and can cause weakness, numbness, trouble walking or talking, vision changes, and other problems). Glatiramer is in a class of medications called immunomodulators. It works by stopping the body from damaging its own nerve cells (myelin).
Read the full MedlinePlus article ↗- 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:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 82983-0430-12 You're viewing this Main listing | 12 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE | 2026-03-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Glatiramer Acetate 40 mg/mL 00378-6961-12 | Mylan | 1 syringe | $86.095 | AP | Availability likely | — |
| Glatopa 40 mg/mL 00781-3250-89 | Sandoz | 1 syringe | $86.095 | AP | Availability likely | — |
| Glatiramer Acetate 40 mg/mL 00832-6085-12 | UPSHER-SMITH | 12 syringes | $86.095 | AP | Availability likely | — |
| Glatiramer Acetate 40 mg/mL 47335-0991-02 | Sun | 1 syringe | $86.095 | AP | Availability likely | — |
| Glatiramer Acetate 40 mg/mL 70710-1549-06 | Zydus | 1 syringe | $86.095 | AP | Availability likely | — |
| Glatiramer Acetate 40 mg/mL 11797-0765-03 | Italfarmaco | 12 syringes | — | AP | FDA listed | — |
| Glatopa 40 mg/mL 63629-8816-01 | Bryant | 1 syringe | — | AP | FDA listed | — |
| Copaxone 40 mg/mL 68546-0325-06 | Teva | 1 syringe | — | AP | FDA listed | — |
| Glatiramer Acetate 40 mg/mLthis 82983-0430-12 | AJENAT | 1 syringe | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Glatiramer Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
40 mg / 1 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from AJENAT PHARMACEUTICALS LLC labeler code 82983
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- Dehydrated Alcohol 1 mL/mL Injection, Solution NDC 82983-426-10
- Lacosamide Oral Solution 10 mg/mL Solution NDC 82983-427-31
- Glycopyrrolate Oral Solution 1 mg/5mL Solution NDC 82983-428-47
- Glatiramer Acetate 20 mg/mL Injection, Solution NDC 82983-429-30
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 ) Glatiramer acetate injection 40 mg/mL three times per week ( 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 doses are: • Glatiramer acetate injection 20 mg per mL: administer once per day or • Glatiramer acetate injection 40 mg per mL: administer three times per week and at least 48 hours apart 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 Ajenat’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 white plunger. For subcutaneous use only. • Injection: 40 mg per mL in a single-dose, prefilled syringe with a blue plunger. For subcutaneous use only. Injection: 20 mg/mL in a single-dose, prefilled syringe with a white plunger ( 3 ) Injection: 40 mg/mL in a single-dose, prefilled syringe with a 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 Warning 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 Ajenat’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 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 immedicate post-injection reactiongs [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-injetcion 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 glatiramer acetate… [Excerpted — this section continues on DailyMed.]
🤒 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 Ajenat Pharmaceuticals, LLC at +1-727-234-8872 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 Hyperhidrosi… [Excerpted — this section continues on DailyMed.]
👥 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, 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 supplied as: 20 mg per mL in a single-dose, prefilled syringe with a white plunger, in individual blister packages supplied in 30-count cartons (NDC 82983-429-30). 40 mg per mL in a single-dose, prefilled syringe with a blue plunger, in individual blister packages supplied in 12-count cartons (NDC 82983-430-12). 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°C to 8°C (36°F to 46°F). If needed, the patient may store glatiramer acetate injection at room temperature, 15°C to 30°C (59°F 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 injection syringe freezes, it should be discarded.
📋 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 injection is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of Glatiramer Acetate Injection solution contains 20 mg or 40 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… [Excerpted — this section continues on DailyMed.]
💬 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 staring 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.
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 with an optional compatible auto… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
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.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Evidence supporting the effectiveness of glatiramer acetate derives from five placebo-controlled trials, four of which used a glatiramer acetate injection dose of 20 mg per mL per day and one of which used a glatiramer acetate injection dose of 40 mg per mL three times per week. Glatiramer Acetate Injection 20 mg per mL per day Study 1 was performed at a single center. Fifty patients were enrolled and randomized to receive daily doses of either glatiramer acetate injection, 20 mg per mL subcutaneously, or placebo (glatiramer acetate injection: n = 25; placebo: n = 25).
Patients were diagnosed with RRMS by standard criteria, and had at least 2 exacerbations during the 2 years immediately preceding enrollment. Patients were ambulatory, as evidenced by a score of no more than 6 on the Kurtzke Disability Scale Score (DSS), a standard scale ranging from 0–Normal to 10–Death due to MS. A score of 6 is defined as one at which a patient is still ambulatory with assistance; a score of 7 means the patient must use a wheelchair.
Patients were examined every 3 months for 2 years, as well as within several days of a presumed exacerbation. To confirm an exacerbation, a blinded neurologist had to document objective neurologic signs, as well as document the existence of other criteria (e.g., the persistence of the neurological signs for at least 48 hours). The protocol-specified primary outcome measure was the proportion of patients in each treatment group who remained exacerbation free for the 2 years of the trial, but two other important outcomes were also specified as endpoints: the frequency of attacks during the trial, and the change in the number of attacks compared with the number which occurred during the previous 2 years.
Table 3 presents the values of the three outcomes described above, as well as several protocol-specified secondary measures. These values are based on the intent-to-treat population (i.e., all patients who received at least 1 dose of treatment and who had at least 1 on-treatment assessment): Table 3: Study 1 Efficacy Results Glatiramer Acetate Injection 20 mg/mL (n = 25) Placebo (n = 25) P-Value % Relapse-Free Patients 14/25 (56%) 7/25 (28%) 0.085 Mean Relapse Frequency 0.6/2 years 2.4/2 years 0.005 Reduction in Relapse Rate Compared to Prestudy 3.2 1.6 0.025 Median Time to First Relapse (days) > 700 150 0.03 % of Progression-Free Progression was defined as an increase of at least 1 point on the DSS, persisting for at least 3 consecutive months.
Patients 20/25 (80%) 13/25 (52%)
0.07Study 2 was a multicenter trial of similar design which was performed in 11 US centers. A total of 251 patients (glatiramer acetate injection: n = 125; placebo: n = 126) were enrolled. The primary outcome measure was the Mean 2-Year Relapse Rate.
Table 4 presents the values of this outcome for the intent-to-treat population, as well as several secondary measures: Table 4: Study 2 Efficacy Results Glatiramer Acetate Injection 20 mg/mL (n = 125) Placebo (n = 126) P-Value Mean No. of Relapses 1.19/2 years 1.68/2 years 0.055 % Relapse-Free Patients 42/125 (34%) 34/126 (27%)
0.25Median Time to First Relapse (days) 287 198 0.23 % of Progression-Free Patients 98/125 (78%) 95/126 (75%)
0.48Mean Change in DSS -0.05 +0.21 0.023 In both studies, glatiramer acetate exhibited a clear beneficial effect on relapse rate, and it is based on this evidence that glatiramer acetate is considered effective. In Study 3, 481 patients who had recently (within 90 days) experienced an isolated demyelinating event and who had lesions typical of multiple sclerosis on brain MRI were randomized to receive either glatiramer acetate injection 20 mg per mL (n = 243) or placebo (n = 238). The primary outcome measure was time to development of a second exacerbation.
Patients were followed for up to three years or until they reached the primary endpoint. Secondary outcomes were brain MRI measures, including number of new T2 lesions and T2 lesion volume… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 2-year carcinogenicity study, mice were administered up to 60 mg/kg/day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose of 20 mg/day on a mg/m 2 basis). No increase in systemic neoplasms was observed. In males receiving the 60-mg/kg/day dose, there was an increased incidence of fibrosarcomas at the injection sites.
These sarcomas were associated with skin damage precipitated by repetitive injections of an irritant over a limited skin area. In a 2-year carcinogenicity study, rats were administered up to 30 mg/kg/day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose on a mg/m 2 basis). No increase in neoplasms was observed.
Mutagenesis Glatiramer acetate was not mutagenic in in vitro (Ames test, mouse lymphoma tk) assays. Glatiramer acetate was clastogenic in two separate in vitro chromosomal aberration assays in cultured human lymphocytes but not clastogenic in an in vivo mouse bone marrow micronucleus assay. Impairment of Fertility When glatiramer acetate was administered by subcutaneous injection prior to and during mating (males and females) and throughout gestation and lactation (females) at doses up to 36 mg/kg/day (18 times the human therapeutic dose on a mg/m 2 basis) no adverse effects were observed on reproductive or developmental parameters.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 2-year carcinogenicity study, mice were administered up to 60 mg/kg/day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose of 20 mg/day on a mg/m 2 basis). No increase in systemic neoplasms was observed. In males receiving the 60-mg/kg/day dose, there was an increased incidence of fibrosarcomas at the injection sites.
These sarcomas were associated with skin damage precipitated by repetitive injections of an irritant over a limited skin area. In a 2-year carcinogenicity study, rats were administered up to 30 mg/kg/day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose on a mg/m 2 basis). No increase in neoplasms was observed.
Mutagenesis Glatiramer acetate was not mutagenic in in vitro (Ames test, mouse lymphoma tk) assays. Glatiramer acetate was clastogenic in two separate in vitro chromosomal aberration assays in cultured human lymphocytes but not clastogenic in an in vivo mouse bone marrow micronucleus assay. Impairment of Fertility When glatiramer acetate was administered by subcutaneous injection prior to and during mating (males and females) and throughout gestation and lactation (females) at doses up to 36 mg/kg/day (18 times the human therapeutic dose on a mg/m 2 basis) no adverse effects were observed on reproductive or developmental parameters.
📖 Instructions for Use ▾
Instructions for Use Glatiramer Acetate Injection (gla tir′ a mer as′ e tate) for subcutaneous use For subcutaneous injection only. Do not inject glatiramer acetate injection in your veins (intravenously). Do not re-use your glatiramer acetate prefilled syringes.
Do not share your glatiramer acetate prefilled syringes with another person. You may give another person an infection or get an infection from them. 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 show you how to give your own injections. Glatiramer acetate injection comes in either 20 mg Prefilled Syringe with needle attached or a 40 mg Prefilled Syringe with needle attached. How often a dose is given depends on the product strength that is prescribed.
Your healthcare provider will prescribe the correct dose for you. If you plan to use your glatiramer acetate product with an autoinjector, ask your healthcare provider or pharmacist to make sure that your autoinjector is meant to be used with your glatiramer acetate product. If you use an autoinjector that is not meant to be used with your glatiramer acetate product, you might not get the correct dose of your medicine.
Instructions for Using Your Glatiramer Acetate 20 mg Prefilled Syringe: Glatiramer acetate injection 20 mg is injected 1 time each day, in the fatty layer under your skin (subcutaneously). Each glatiramer acetate injection 20 mg prefilled syringe is for single use (1 time use) only. The glatiramer acetate injection 20 mg dose is packaged in boxes of 30 prefilled syringes with needles attached.
Glatiramer acetate injection 20 mg prefilled syringes have white plungers. Instructions for Using Your Glatiramer Acetate 40 mg Prefilled Syringe: Glatiramer acetate injection 40 mg is injected 3 times each week, in the fatty layer under your skin (subcutaneously). Glatiramer acetate injection 40 mg should be given on the same 3 days each week, if possible, for example, Monday, Wednesday, and Friday.
Give your glatiramer acetate injections at least 48 hours (2 days) apart. Each glatiramer acetate 40 mg prefilled syringe is for single use (1 time use) only. The glatiramer acetate injection 40 mg dose is packaged in boxes of 12 prefilled syringes with needles attached.
Glatiramer acetate 40 mg prefilled syringes have blue plungers. How do I inject glatiramer acetate injection? S tep 1 : Gather the supplies you will need to inject glatiramer acetate injection.
See Figure A. 1 blister pack with a glatiramer acetate prefilled syringe with needle attached Alcohol wipe (not supplied) Dry cotton ball (not supplied) A place to record your injections, like a notebook (not supplied) Sharps disposal container (not supplied). See Step 13 below, “Dispose of your needles and syringes”.
Figure A Step 2 : Remove only 1 blister pack from the glatiramer acetate prefilled syringe carton. See Figure B. Figure B Place the supplies you will need on a clean, flat surface in a well-lit area.
After you remove 1 blister pack from the carton, keep all unused syringes in the carton and store them in the refrigerator. Let the blister pack, with the syringe inside, warm to room temperature for about 20 minutes. Wash your hands.
Be careful not to touch your face or hair after washing your hands. Step 3 : Look closely at your glatiramer acetate prefilled syringe. There may be small air bubbles in the syringe.
Do not try to push the air bubble from the syringe before giving your injection so you do not lose any medicine. Check the liquid medicine in the syringe before you give your injection. The liquid in the syringe should look clear, and colorless, and may look slightly yellow.
If the liquid is cloudy or contains any particles, do not use the syringe and throw it away in a sharps disposal container. See Step 13 below, “Dispose of your needles and syringes.” Step 4 : Choose your injection… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – 20 mg/mL Syringe Label: Blister Label: Carton (12 Pack): Syringe Label Blister Label Carton Label
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