On June 24, 2021, the FDA issued an Emergency Use Authorization (EUA) for intravenous Actemra® (tocilizumab) for the treatment of COVID-19 in 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). However, Actemra is not FDA-approved for this use. The EUA is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used under the EUA).
ACTEMRA is authorized for emergency use under an Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized children (2 years of age and older) who are receiving corticosteroids and who require supplemental oxygen, or a machine that helps with their breathing (ventilator) or a machine that adds oxygen to the blood outside the body (extracorporeal membrane oxygenation or ECMO).
ACTEMRA is not FDA-approved for use in patients with COVID-19 under 18 years of age. There is limited information known about the safety or effectiveness of using ACTEMRA to treat children in the hospital with COVID-19. The safety and effectiveness of ACTEMRA have not been studied in children hospitalized with COVID-19.
The EUA for ACTEMRA is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the products may no longer be used under the EUA).
ACTEMRA can cause serious side effects. The most important side effects include:
The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.
Patients should not receive ACTEMRA if they are allergic to tocilizumab or if they have had a bad reaction to ACTEMRA previously.
ACTEMRA & pregnancy:
There is limited experience giving ACTEMRA to pregnant women or breastfeeding mothers. ACTEMRA may harm the patient’s unborn baby. It is unknown if ACTEMRA passes into a patient’s breast milk. If a patient is pregnant or breastfeeding, they can discuss their options and specific situation with their doctor.
If a patient is pregnant or becomes pregnant while taking ACTEMRA, they should join the pregnancy registry. To learn more, patients can call the registry at 1-877-311-8972 or talk to their doctor to enroll.
Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.
“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease. We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.”
“Industries, governments and academic institutions have come together to develop solutions to address the enormous challenges of the pandemic. We are proud of the partnerships that we’ve created and the progress we’ve made in conducting scientifically rigorous trials of Actemra in COVID-19. We are committed to collaborating closely with our distribution partners to enable access to Actemra in hospitals across the country to help adults and children with COVID-19, as well as people who depend on the medicine for its FDA-approved indications.”