Public Health Emergency - Leading a Nation Prepared
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the
emergency use of REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate coronavirus disease 2019 (COVID -19) in adult 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 progression to severe COVID-19, including hospitalization or death. Monoclonal antibodies are used to neutralize the COVID-19 virus and intended to prevent progression of disease. The U.S. Government is currently supplying REGEN-COV (casirivimab and imdevimab) for the treatment and post-exposure prophylaxis of COVID-19. The dosing is the same for both indications (casirivimab 600mg and imdevimab 600mg).
Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and
authorization of mAb therapy is not limited to the medical conditions or factors listed above. (For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, visit the
Equipment requirements may vary by medical direction. Follow your local requirements when determining the equipment needed for your treatment setting. The following equipment should be considered to ensure the most optimal care environment for patients receiving REGEN-COV. This list is not intended to substitute for your independent medical judgment.
Personal Protective Equipment
Casirivimab and imdevimab are preservative-free. Discard any unused portion after use. Store unopened vials in a refrigerator at 2ºC to 80°C (36°F to 46°F) in the original carton to protect from light.
DO NOT FREEZE - DO NOT SHAKE - DO NOT EXPOSE TO DIRECT LIGHT OR HEAT
If given by intravenous infusion, solution in vial requires dilution prior to administration. The prepared infusion solution is intended to be used immediately. If immediate administration is not possible, store diluted casirivimab and imdevimab solution in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF) for no more than 36 hours or at room temperature up to 25ºC (77ºF) for no more than 4 hours. If refrigerated, allow the infusion to equilibrate to room temperature for approximately 30 minutes prior to administration.
If given by subcutaneous injection, the prepared syringes should be used immediately. If immediate administration is not possible, store the prepared casirivimab and imdevimab syringes in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF) for no more than 4 hours or at room temperature up to 25ºC (77ºF) for no more than 4 hours. If refrigerated, allow the syringes to equilibrate to room temperature for approximately 20 minutes prior to administration.
Follow the usual documentation requirements relevant to medication administration, patient assessments, and vital signs monitoring, including any adverse reactions.
Remove the casirivimab and imdevimab vial(s) from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Do not expose to direct heat. Do not shake the vial(s).
Inspect casirivimab and imdevimab vial(s) visually for particulate matter and discoloration prior to administration. Should either be observed, the vial must be discarded, and a new vial must be used. The solution for each vial should be clear to slightly opalescent, colorless to pale yellow.
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