FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection
[8/18/2022] FDA is alerting patients, caregivers, and health care professionals that autoinjector devices that are optional for use with glatiramer acetate injection may not be compatible for use across FDA-approved glatiramer acetate injection drug products. FDA has received reports that using an autoinjector that is not compatible with the patient’s specific glatiramer acetate injection drug product has resulted in missed and partial doses. Glatiramer acetate injection is used in the treatment of relapsing forms of multiple sclerosis. There are currently three FDA-approved glatiramer acetate injection drug products on the market—all available in a single-dose prefilled syringe with an attached needle for subcutaneous administration. Patients may inject glatiramer acetate using only the syringe or by inserting the sy...