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    • COVID-19 Vaccine Resource Guide
    • Health Plan Policies
    • Advocating oxygen improvement
    • Supporting Your Workforce During COVID-19
    • Update for Nurses Licensed Outside of Florida
    • Important Updates >
      • Important Updates Regarding Nurses Licensed Outside of Florida
      • Important Updates Regarding the Direct Order and Reporting Process for Monoclonal Antibodies
      • Important Updates Regarding the FDA Emergency Use Authorization for Monoclonal Antibody Cocktail - Casirivimab and Imdevimab
      • Expanded Emergency Declaration Under 49 CFR § 390.23 No. 2020-002 (Relating to COVID-19)
  • Advocacy
    • State Advocacy
    • Federal Advocacy
    • FHA Political Committee
    • Health Care Issues >
      • Accreditation
      • Compliance/HIPAA
      • Emergency Management
      • Finance
      • Quality & Safety
  • Education & Events
    • Calendar
    • Popular Education Series >
      • Workforce Resilience Series
      • Novice Infection Prevention Series
    • Sponsor Opportunities
  • Reports & Resources
    • Facts and Stats
    • Florida Nurse Workforce Projections - 2035
    • Understanding Your Hospital Bill
    • Guidance Documents
    • Medicare 101 Manual
    • Compliance Standards Manual
    • Florida HIPAA Preemption Analysis
  • News
  • About Us
    • Our Team
    • Board of Trustees
    • Member Directory
Important Updates Regarding the FDA Emergency Use Authorization for Monoclonal Antibody Cocktail - Casirivimab and Imdevimab
July 28, 2021​
FDA Updates Emergency Use Authorization for Monoclonal Antibody Cocktail - Casirivimab and Imdevima
​The U.S. Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) for REGEN-COV™, adding an alternative route of administration (subcutaneous) and lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized. The EUA provides that casirivimab and imdevimab are to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients 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.

Additional Resources
  • Important Prescribing Information Regarding REGEN-COV™ (casirivimab and imdevimab)
  • Fact Sheet for Health Care Providers Regarding EUA of REGEN-COV™ (casirivimab and imdevimab)
  • Information Regarding Monoclonal Antibodies for High-Risk COVID-19 Positive Patients
  • Monoclonal Antibody Resources for Clinicians
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