Glatiramer Acetate

Clinical summary

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 ) 2.1 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 Upsher-Smith’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 )] 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 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 Upsher-Smith’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 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 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 )] . 5.2 Immediate 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: f