FDA Warns Patients, Caregivers, and Healthcare Providers About Interoperability Issues with Optional Autoinjector Devices for Use with Glatiramer Acetate Injections
August 18, 2022 FDA advises patients, caregivers, and health care professionals that the optional auto-injector device for use with glatiramer acetate injection may not be compatible for use with the entire FDA-approved glatiramer acetate injectable product line. I am warning you. FDA has received reports of missed doses and partial doses when patients used auto-injectors that were incompatible with certain glatiramer acetate injectable products.
Glatiramer acetate injection is used to treat relapsing multiple sclerosis. There are currently three FDA-approved glatiramer acetate injectable products on the market, all available in single-dose, pre-filled syringes with attached needles for subcutaneous administration. Patients can inject glatiramer acetate using the syringe alone or by inserting the syringe into an autoinjector. Auto-injectors are reusable, designed to facilitate injections for patients with limited dexterity, and require a separate prescription.
The table below shows the three FDA-approved glatiramer acetate injectable products and their optional compatible autoinjector devices.
|Formulation name||Pharmaceutical manufacturer||Compatible autoinjector|
|Copaxone (glatiramer acetate injection)||Teva Pharmaceutical||Autoject 2|
|Glatopa (glatiramer acetate injection)||sand||GratopaJecht|
|glatiramer acetate injection||Beatrice/Mylan||WhisperJecht|
The FDA has requested that drug manufacturers update their labeling to instruct users to verify that the autoinjector is compatible before using it to inject glatiramer acetate. Users can confirm suitability by consulting a medical professional or by visiting the pharmaceutical company’s patient information website. Users should ensure that their auto-injectors are compatible each time they receive a new prescription for glatiramer acetate injectable product.
FDA encourages healthcare professionals and patients to report any adverse events or quality issues they experience 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. Alternatively, download the form, complete it, and fax it to 1-800-FDA-0178.