On June 25, 2021, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Actemra (tocilizumab; Genentech Inc.) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients with COVID-19.
In clinical trials of hospitalized patients with COVID-19, Actemra (in addition to routine care) was shown to reduce the risk of death through 28 days of follow-up, and decrease the amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.
The FDA has posted fact sheets for health care providers and patients, parents, and caregivers. These fact sheets include dosing instructions, potential side effects, and drug interactions. Common side effects of Actemra observed in the COVID-19 trials include constipation, anxiety, diarrhea, insomnia, hypertension and nausea.
Food and Drug Administration (FDA). Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19 [news release]. June 25, 2021. Available at: click here. Accessed June 25, 2021.