[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 syringe into an autoinjector. The autoinjectors are reusable, designed to facilitate injections in patients with limited dexterity, and are available by prescription separately.
The table below lists the three FDA-approved glatiramer acetate injection drug products and its compatible autoinjector device that is optional for use.
|Drug Product Name||Drug Manufacturer||Compatible Autoinjector Device|
|Copaxone (glatiramer acetate injection)||Teva Pharmaceuticals||autoject 2 for glass syringe|
|Glatopa (glatiramer acetate injection)||Sandoz||Glatopaject|
|Glatiramer Acetate injection||Viatris/Mylan||WhisperJECT|
FDA has requested that drug product manufacturers update their labeling to instruct users to confirm the autoinjector is compatible before using it to inject glatiramer acetate. Users can confirm compatibility by speaking with their health care professional or visiting the drug manufacturer's patient information website. Users should also confirm the autoinjector is compatible each time they receive a new prescription for a glatiramer acetate injection drug product.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced using glatiramer acetate injection products to FDA’s MedWatch Adverse Event Reporting program. Complete and submit the report online at www.fda.gov/medwatch/report.htm; or download and complete the form, then submit it via fax at 1-800-FDA-0178.