8/18/2022 FDA is alerting sufferers, caregivers, and well being care professionals that autoinjector gadgets which are non-obligatory to be used with glatiramer acetate injection will not be appropriate to be used throughout FDA-approved glatiramer acetate injection drug merchandise. FDA has acquired experiences that utilizing an autoinjector that isn’t appropriate with the affected person’s particular glatiramer acetate injection drug product has resulted in missed and partial doses.
Glatiramer acetate injection is used within the remedy of relapsing types of a number of sclerosis. There are at the moment three FDA-approved glatiramer acetate injection drug merchandise in the marketplace—all obtainable in a single-dose prefilled syringe with an hooked up needle for subcutaneous administration. Sufferers might inject glatiramer acetate utilizing solely the syringe or by inserting the syringe into an autoinjector. The autoinjectors are reusable, designed to facilitate injections in sufferers with restricted dexterity, and can be found by prescription individually.
The desk beneath lists the three FDA-approved glatiramer acetate injection drug merchandise and its appropriate autoinjector gadget that’s non-obligatory to be used.
| Drug Product Title | Drug Producer | Appropriate Autoinjector Gadget |
|---|---|---|
| Copaxone (glatiramer acetate injection) | Teva Prescribed drugs | Autoject 2 |
| Glatopa (glatiramer acetate injection) | Sandoz | Glatopaject |
| Glatiramer Acetate injection | Viatris/Mylan | WhisperJECT |
FDA has requested that drug product producers replace their labeling to instruct customers to substantiate the autoinjector is appropriate earlier than utilizing it to inject glatiramer acetate. Customers can affirm compatibility by talking with their well being care skilled or visiting the drug producer’s affected person data web site. Customers must also affirm the autoinjector is appropriate every time they obtain a brand new prescription for a glatiramer acetate injection drug product.
FDA encourages well being care professionals and sufferers to report hostile occasions or high quality issues skilled utilizing glatiramer acetate injection merchandise to FDA’s MedWatch Opposed Occasion Reporting program. Full and submit the report on-line at www.fda.gov/medwatch/report.htm; or obtain and full the shape, then submit it through fax at 1-800-FDA-0178.
