The Food and Drug Administration (FDA) has issued a safety communication regarding cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection.
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 optional, reusable autoinjectors, which are prescribed separately, are designed to facilitate injections in patients with limited dexterity.
There are currently 3 FDA-approved glatiramer acetate injection drug products on the market, each with its own compatible autoinjector device:
- Copaxone (Teva Pharmaceuticals); Autoject 2
- Glatopa (Sandoz); Glatopaject
- Glatiramer Acetate Injection (Viatris/Mylan); WhisperJECT
According to the FDA, using an incompatible autoinjector may increase the risk for medication errors. The agency has received reports of missed and partial doses when an autoinjector that was not compatible with the patient’s specific glatiramer acetate injection product was used to administer medication.
To reduce the risk of medication errors, patients should confirm that their autoinjector device is compatible before using it to inject glatiramer acetate; compatibility should also be ascertained when a new prescription is received. The auotinjector labeling provides information on drug product compatibility.
Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.
FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection. News release. US Food and Drug Administration. August 18, 2022. Accessed August 22, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-caregivers-and-health-care-providers-cross-compatibility-issues-autoinjector