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.
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:
- Obesity BMI>25
- Diabetes, any immunosuppression, and heart or lung disease, or chronic kidney disease
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy
- Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID 19
- Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19
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.
As of July 30, 2021, the Food and Drug Administration (FDA) has expanded the COVID-19 monoclonal antibody therapeutic REGEN-COV (casirivimab and imdevimab) Emergency Use Authorization (EUA) to include post-exposure prophylaxis. Please reference the Fact Sheet for Health Care Providers Emergency Use Authorization of REGEN-COV™ (casirivimab and imdevimab) for more detail.
This new authorized use is in addition to the prior authorization of REGEN-COV to treat non-hospitalized patients with mild to moderate COVID-19 in adult and pediatric patients, age 12 and older, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID 19, including hospitalization or death.
It should be noted that post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19, and REGEN-COV is not authorized for pre-exposure prophylaxis.
HHS has transitioned from direct ordering of monoclonal antibodies to a state-coordinated distribution system. Hospitals and other administration sites will no longer order from AmeriSource Bergen directly. The federal government will determine the total allocation amount for each state based upon state cases and hospitalizations, and utilization as reported to HHS Protect / TeleTracking. ADH will determine which sites will receive MAbs and allocation amount.
Orders must be placed by COB each Monday. The order should be based upon the 7 day average of what your facility uses, and you should only order what you expect to use in one week. Most shipments will be for REGEN-COV (quantities of 48). Less BAM/ETE will be distributed, and only to sites that have previously administered the treatment (quantities of 50). Most shipments will go directly to your facility from Amerisource Bergen. For all new sites, or special circumstances, MAbs will come directly from ADH and delivery will be coordinated with the site.
NIH has recently updated treatment guidelines to help prioritization when supplies are low.
There are multiple REGEN-COV packaging variations (co-formulated, non-co-formulated doses). Please verify package inserts upon delivery and follow proper administration procedures for the version your site received. Additionally, all REGEN-COV products can be administered via intravenous infusion and/or subcutaneous injections.
Locations in Arkansas Receiving Monoclonal Antibodies