COVID-19 Guidance About Monoclonal Antibodies
In November, the U.S. Food and Drug Administration issued an Emergency Use Authorization to allow the use of monoclonal antibodies for the treatment of mild to moderate symptoms of COVID-19 in adults and pediatric patients.
Monoclonal antibodies are laboratory-made proteins that mimic your immune system’s ability to fight off harmful viruses. Bamlanivimab and casirivimab + imdevimab are monoclonal antibodies that are specifically designed to protect against the spike protein of COVID-19. These proteins are designed to stop the virus from entering the human cells.
Who can get this treatment?
Non-hospitalized patients with mild to moderate symptoms with less than 10 days since symptom onset & high-risk factors including:
- Age >65 years, or >55 years and 12-17 years with:
- Obesity with BMI >35 (adults)
- High-risk conditions including diabetes, chronic kidney disease, coronary artery disease, hypertension and others
These medications are NOT approved for use in patients who are hospitalized due to COVID-19 or require oxygen therapy. Benefits of treatment have not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when given to patients with COVID-19 requiring oxygen ventilation. Individual administration sites may have additional criteria for use of these monoclonal antibody therapies in patients.
These medications will be available at no cost to patients, although health care facilities may charge for administering the medicine.
- HHS Protect Public Data Hub: Monoclonals Distribution Locations
- Monoclonal Antibodies for treatment of COVID-19 | Spanish
- Casirivimab & Imdevimab: Emergency Use Authorization | Patient fact sheet | FAQ | FAQ part II | FDA Fact Sheet
- Bamlanivimab/ETesevimab: Emergency Use Authorization
- HHS Flyer
- Variants of Concern
- COVID-19 Antibody Therapy Resources Center
- FDA Revokes Emergency Use Authorization for Bamlanivimab for treatment of mild to moderate COVID 19
- Alert to Arkansas medical providers
- FAQs for mAB infusion in non-hospital sites
Long-term Care Facilities
- Arkansas facilities receiving medication under Special Projects for Equitable and Efficient Distribution
- FAQs for Monoclonal Antibody (mAB) infusion in non-hospital sites
- Guidance for Use of Monoclonal Antibodies in Long-Term Care Facilities
- NHIA bamlanivimab pilot program
- Monoclonal antibody treatments in long-term care settings
- Sample Patient Order Sheet and Consent Forms
- Special Projects for Equitable and Efficient Distribution (SPEED) to Priority Populations
Locations in Arkansas receiving monoclonal antibodies