Public Health Emergency - Leading a Nation Prepared
FDA Emergency Use Authorizations allow healthcare providers to administer COVID-19 monoclonal antibody (mAb) therapeutics to individuals who have been exposed to COVID-19 or individuals who have been infected and have mild to moderate symptoms.
High-risk COVID-19 outpatients must receive treatment within 10 days of symptom onset. Also, consider:
Post-exposure prophylactic treatment of high-risk individuals should occur as soon as possible following exposure to SARS-CoV-2. Repeat dosing may be appropriate for individuals who have ongoing exposure to SARS-CoV-2 for longer than 4 weeks and who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination.
Healthcare providers can prescribe COVID-19 mAb therapeutics for post-exposure prophylaxis to individuals who have one or more of the high-risk factors and either:
Note: Only one mAB product, REGEN-COV, is authorized for prophylactic use.
Outpatients can be prescribed COVID-19 mAb therapeutics if they have one or more of the high-risk factors and:
Emergency Use Authorizations for COVID-19 mAbs provide latitude to healthcare providers to exercise their clinical judgment for both prophylactic use and use with individuals who have mild to moderate COVID-19 symptoms. These individuals may be eligible for monoclonal antibody treatment if they meet the following criteria for REGEN-COV TM (casirivimab with imdevimab), bamlanivimab and etesevimab, and sotrovimab:
For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC’s information on ways that COVID-19 affects people with
certain medical conditions.
To guide outpatient treatment decisions:
In addition to outpatient treatments, the FDA granted EUA for a recombinant humanized monoclonal antibody,
Actemra (tocilizumab,) for certain hospitalized COVID-19 patients.
Treatment can be provided by intravenous infusion or by subcutaneous injection. Subcutaneous injection is authorized by the FDA as an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment.
Because the federal government has purchased a supply of certain monoclonal antibody treatments, there is no cost to individuals for the monoclonal antibody products themselves; however, there may be costs incurred from administration of the product. Both Medicare and Medicaid/CHIP cover costs for infusion and subcutaneous routes of administration.
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