FDA Alert Regarding the Use of Compatibility of Optional Autoinjectors for Glatiramer Acetate Products

Today, the FDA released an alert (here) warning of potential cross-compatibility issues with the use of autoinjectors for injection of the glatiramer used for the relapsing‑remitting form of multiple sclerosis.  The alert is directed at patients, caregivers, and healthcare providers.

The FDA says it has “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.”  It notes that there are currently three approved applications for glatiramer acetate injection and each has its own optional autoinjector available to help patients with reduced dexterity to inject the prefilled syringes.

The table below, included in the alert, shows the three products and the proper compatible autoinjector.

The FDA is asking manufacturers to “update labeling to instruct users to confirm the autoinjector is compatible before using it to inject glatiramer acetate” and, each time a user receives a new prescription or refill, to ensure that they will be using a compatible autoinjector.  Because the autoinjectors were not approved in the drug applications, patients and caregivers may have used the same autoinjector they purchased or received even if the product dispensed came from a different manufacturer.  The first generic for the branded glatiramer acetate injection was approved on April 16, 2015.  It is interesting to note that it has taken a little over seven years for this issue to surface to this level of concern by the Agency.  In the notice, there is no indication of the frequency of failure of the devices, as reported to the FDA, when used with a different approved product, nor a comparison of the rate of failures using the “compatible” device with the correct product.