ATLANTA—The ACR is actively engaged with the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra). Demand for tocilizumab has outpaced supply, with demand increasing after the FDA’s June 24 Emergency Use Authorization (EUA) for tocilizumab to be used for the treatment of COVID-19 in some hospitalized adult and pediatric patients.
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The manufacturer has indicated in an Aug. 16 update that providers may currently find tocilizumab IV supplies to be unavailable due to high demand, but they expect IV stock replenishments by the end of August. Measures are being taken to expedite replenishments and increase manufacturing capacity and supply wherever possible, but they have indicated additional intermittent shortage periods may occur in the months ahead if the COVID-19 pandemic continues at the current pace.
According to their statement, subcutaneous formulations (pens and pre-filled syringes) continue to be available for patients prescribed tocilizumab for FDA-approved indications, and these are not authorized for treatment of COVID-19 patients under the EUA.
Providers experiencing trouble obtaining tocilizumab IV or any other issues related to COVID-19 can contact the ACR at [email protected].