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FDA labels · Drug interactions · Beers Criteria · NIOSH 2024 · RxNorm · v3.0.0

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💊 GLATIRAMER ACETATE

☠ BLACK BOX WARNING
SUBCUTANEOUS FDA Label
☠
FDA BLACK BOX WARNING

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. �…

Quick reference
RouteSUBCUTANEOUS
ManufacturerZydus Pharmaceuticals USA Inc.
SourceFDA Label
✅ Indications & 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 & 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 )

2.1 Recommended 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.

2.2 Instructions 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 Zydus' 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 )].

🚫 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 & Precautions ›

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 injection can modify immune response ( 5.5 ) Hepatic Injury: if signs or symptoms of hepatic dysfunction occur, consider discontinuing glatiramer acetate injection ( 5.6 ) Glatiramer Acetate Products and Administration Errors: Using an optional autoinjector that is not compatible for use with Zydus's Glatiramer acetate injection may increase the risk for medication errors, such as dose omission or administration of a partial dose. ( 5.7 )

5.1 Anaphylactic 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 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 m... [See full FDA label]

🔴 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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical 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 m... [See full FDA label]

🤰 Pregnancy ›

8.1 Pregnancy 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 ›

8.4 Pediatric Use The safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age.

👴 Geriatric Use ›

8.5 Geriatric Use Glatiramer acetate injection has not been studied in elderly patients.

🔬 Mechanism of Action ›

12.1 Mechanism 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 )] .

📊 Pharmacokinetics ›

12.3 Pharmacokinetics 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.

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