Glatiramer Acetate Label Update: Medication Errors With Incompatible Autoinjectors

The labels for glatiramer acetate injection products have been updated to include a new warning that using an optional autoinjector that is not compatible with the product may increase the risk of medication errors.

Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. The label update follows an earlier safety alert issued by the Food and Drug Administration (FDA) regarding reports of administration errors with incompatible autoinjectors.

Autoinjector devices that are optional for use with glatiramer acetate products are prescribed separately and are designed to facilitate injections in patients with limited dexterity. While some glatiramer acetate products can be administered using an optional compatible autoinjector, some products must only be administered using the prefilled syringe. 

The following is a list of FDA-approved glatiramer acetate injection products and the compatible autoinjector: 

• Copaxone (Teva Pharmaceuticals): none
• Glatopa (Sandoz); Glatopaject
• Glatiramer Acetate Injection (Viatris/Mylan); WhisperJECT

If an optional autoinjector is used for administration, patients should ensure the device is compatible for use with their specific glatiramer acetate product by referring to the autoinjector labeling or contacting the drug manufacturer for more information. According to the agency, the availability of compatible autoinjectors for each glatiramer acetate product may change with time.

This article originally appeared on MPR