New packaging for REGEN-COV monoclonal antibodies may add confusion

New packaging for REGEN-COV monoclonal antibodies may add confusion

Regeneron has informed us about new alternative packaging for casirivimab and imdevimab (REGEN-COV). The new packaging contains individual, separate vials of each antibody solution, which are co-packaged together in a carton labeled as “casirivimab and imdevimab 120 mg/mL concentrate for solution for infusion.” The co-packaged cartons were manufactured by Regeneron’s development partner, Roche Pharmaceuticals, for distribution outside the US. However, the product will also be distributed by Regeneron in the US under an Emergency Use Authorization (EUA) to increase the availability of casirivimab and imdevimab and to help combat the ongoing COVID-19 public health emergency. To help meet demand, the new co-packaged product will be distributed in addition to the current presentations of co-formulated REGEN-COV (casirivimab and imdevimab in a vial together) and dose packs of cartons containing individual vials of casirivimab and imdevimab. Importantly, because the co-formulated product is also being distributed, the co-packaged carton labeling may cause some users to mistakenly believe the vials inside the carton each contain the co-formulated product, although once the carton is opened, each vial is clearly marked, identifying the individual monoclonal antibody by its nonproprietary name. For details, please see the announcement and photos click here.

Also, while the co-packaged cartons contain the same monoclonal antibodies that are approved for use in the US under the EUA, the carton and vial labels do not include a National Drug Code (NDC) number. The cartons say, “For Pandemic Use” instead of “For EUA Use.” Additionally, the barcode on the carton label may not be functional, and barcodes are not provided on the vial labels. Organizations will need to manually input the product information into their systems to confirm the barcodes do not provide incorrect information when the product is scanned. The NDC number is only provided in the quick reference guide that is shipped with the product. This reference guide also provides a QR code that leads to the current US Fact Sheet, which should be used by US healthcare providers, as the package leaflet in the carton is not approved for US use and should be discarded. According to Regeneron, the vials in the co-packaged carton may be used to prepare and administer intravenous (IV) infusions as well as subcutaneous injections, despite containing statements such as “Concentrate for solution for infusion” or “For intravenous infusion after dilution.”