Emergency Use Authorization (EUA) for use of ACTEMRA for the treatment of COVID-19 1
The US Food and Drug Administration (FDA) has issued an EUA for the emergency use of ACTEMRA for the treatment of coronavirus disease 2019 (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. However, ACTEMRA is not FDA-approved for this use.
ACTEMRA is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ACTEMRA under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Use in pediatric patients or specific populations
For information on use in pediatrics or specific populations, see section 8 of the Fact Sheet for Healthcare Professionals.
Patient counseling information
As a healthcare practitioner, you must communicate to the patient and/or caregiver information consistent with the Fact Sheet for Patients, Parents and Caregivers and provide them with a copy of this Fact Sheet prior to administration of ACTEMRA. However, if providing this information will delay the administration of ACTEMRA to a degree that would endanger the life of a patient, the information must be provided to the parent and/or caregiver as soon as feasible after ACTEMRA administration.
Protecting your patients from illegitimate medicines
ACTEMRA is available only through authorized distributors that have made a commitment to product integrity.
Be cautious of new or unfamiliar distributors that offer ACTEMRA at substantially lower prices that may be "too good to be true"; the product being offered may be illegitimate.
If you suspect that you have received an illegitimate medicine, contact Genentech's Product Complaint Hotline at 1-800-334-0290, and file a report with the FDA’s Office of Criminal Investigations (OCI): call 1-800-551-3989 or visit www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm
Download the EUA Fact Sheets
These Fact Sheets provide essential information on the authorized use of ACTEMRA and the terms of the EUA.