For U.S. Healthcare Professionals only
For U.S. Patients and Caregivers only
EUA FACT SHEET HCP | PATIENT FDA LETTER OF AUTHORIZATION DEAR HCP LETTER
Authorized Use and Important Information for Healthcare Professionals
REGEN-COV (casirivimab with imdevimab) is an investigational therapy and has been authorized by FDA for the emergency use described below. It is not FDA approved for any use, and its safety and effectiveness have not been fully established.
This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.
Resources for Patients and Caregivers
FACTSHEET FOR PATIENTS AND CAREGIVERS (ENGLISH)Find Antibody Infusion Sites Near You
LOCATE ANTIBODY INFUSION CENTERS (ASPR)Resources for Healthcare Providers
FACTSHEET FOR U.S. HEALTH CARE PROVIDERS (ENGLISH)Resources for Patients and Caregivers
FACTSHEET FOR PATIENTS AND CAREGIVERS (ENGLISH)REGEN-COV (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. [see Limitations of Authorized Use]
Limitations of Authorized Use
Definition of High Risk Patients
High risk is defined as patients who meet at least one of the following criteria:
HHS Resources for HCPs
Factsheet: Monoclonal Antibody Treatment for High Risk COVID-19 Positive Patients
The development and manufacturing of casirivimab and imdevimab has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) under OT number: HHSO100201700020C.
REGEN-COV (casirivimab with imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.
REGEN-COV (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. [see Limitations of Authorized Use]
Limitations of Authorized Use:
Definition of High Risk Patients
High risk is defined as patients who meet at least one of the following criteria:
REGEN-COV (casirivimab with imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.
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