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CENTER FOR DRUG EVALUATION AND RESEARCH
DIVISION of
DRUG INFORMATION
Your source for the latest drug information. Know the moment it happens.
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FDA Authorizes Kineret Injection for Treatment of COVID-19 in Certain Hospitalized Adults
FDA has issued an emergency use authorization (EUA) for Kineret (anakinra) injection for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is currently FDA-approved for treatment of rheumatoid arthritis, cryopyrin-associated periodic syndromes, and deficiency of IL-1 receptor antagonist.
The most common adverse reactions (incidence ≥ 1%) with use of Kineret are elevated liver enzymes, neutropenia (an abnormally low count of a type of white blood cell), rash, and injection site reactions. Kineret has been associated with an increase of serious infections in patients with rheumatoid arthritis. Additional safety information, dosing instructions, and potential side effects can be found in the EUA Fact Sheet for Health Care Providers.
Additional information on authorized COVID-19 treatments is available on FDA’s Emergency Use Authorization webpage.
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