Glatiramer Acetate Prescribing Information
• 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.]5.1 Anaphylactic ReactionsLife-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)]• 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.[seeand4 CONTRAINDICATIONSGlatiramer 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
]5.1 Anaphylactic ReactionsLife-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)]
• 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
• 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 .• Glatiramer acetate injection is contraindicated in patients with a history of hypersensitivity reactions to glatiramer acetate injection, including anaphylaxis .
Contraindications (
Known hypersensitivity to glatiramer acetate or mannitol
Warnings and Precautions (
Because glatiramer acetate can modify immune response, it may interfere with immune functions. For example, treatment with glatiramer acetate may interfere with the recognition of foreign antigens in a way that would undermine the body's tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate does this, but there has not been a systematic evaluation of this risk. Because glatiramer acetate is an antigenic material, it is possible that its use may lead to the induction of host responses that are untoward, but systematic surveillance for these effects has not been undertaken.
Although glatiramer acetate is intended to minimize the autoimmune response to myelin, there is the possibility that continued alteration of cellular immunity due to chronic treatment with glatiramer acetate may result in untoward effects.
Glatiramer acetate-reactive antibodies are formed in most patients receiving glatiramer acetate. Studies in both the rat and monkey have suggested that immune complexes are deposited in the renal glomeruli. Furthermore, in a controlled trial of 125 RRMS patients given glatiramer acetate injection 20 mg per mL, subcutaneously every day for 2 years, serum IgG levels reached at least 3 times baseline values in 80% of patients by 3 months of initiation of treatment. By 12 months of treatment, however, 30% of patients still had IgG levels at least 3 times baseline values, and 90% had levels above baseline by 12 months.
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.
• For subcutaneous injection only; doses are not interchangeable ()2.1 Recommended DoseGlatiramer 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.
• Glatiramer acetate injection 20 mg/mL per day ()2.1 Recommended DoseGlatiramer 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.
• Before use, allow the solution to warm to room temperature ()2.2 Instructions for UseRemove 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
[seeWarnings and Precautions (5.7)].
• Injection: 20 mg per mL in a single-dose, prefilled syringe with a light blue plunger. For subcutaneous use only.
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 (
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.
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/m2basis). 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.
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.
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/m2basis). 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.
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.