December 21, 2022
The FDA approved a new indication for Actemra (tocilizumab) injection (PDF, 2.6 MB) for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic
corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
FDA first issued an EUA for Actemra in hospitalized adult and pediatric patients (2 years of age and older) for the same use on June 24, 2021.
Actemra remains authorized for emergency use for the same indication for hospitalized pediatric patients ages 2 to less than 18 years who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. FDA has revised the Letter of Authorization (PDF, 249 KB) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information (PDF, 2.6 MB).