FDA Issues Labeling Updates for Glatiramer Acetate Injection Products

May 20, 2024
The FDA has issued new warnings and updates for glatiramer acetate injection products, alerting patients and healthcare professionals about the risk of medication errors when using incompatible autoinjectors. Patients are advised to confirm compatibility with their healthcare professional or the drug manufacturer each time they receive a new prescription.

On May 16, the FDA alerted patients, caregivers, and healthcare professionals of labeling updates for glatiramer acetate injection products. Updated labeling includes a new warning that using an autoinjector that is not compatible with a specific glatiramer acetate injection product may increase the risk for medication errors, such as a missed dose or administration of a partial dose. 

FDA is also alerting patients and healthcare professionals that some glatiramer acetate injection products may be administered using an optional compatible autoinjector, while other glatiramer acetate injection products must only be injected using the prefilled syringe. The availability of optional compatible autoinjectors for each glatiramer acetate injection drug product may change with time. 

FDA will not further update the table of glatiramer acetate injection products and their optional compatible autoinjector devices included in the below CDER Alert issued on August 18, 2022. 

Patients can continue to confirm the compatibility of their autoinjector by speaking with their healthcare professional, visiting the drug manufacturer's patient information website, contacting the drug manufacturer for more information, or referring to the autoinjector labeling. Patients should also continue to confirm their autoinjector is compatible each time they receive a new prescription for a glatiramer acetate injection drug product.