If I've Been Vaccinated, Can I Still Use This Treatment?
Yes. Patients who have received a COVID-19 vaccine can still receive monoclonal antibody therapy if they meet the authorized use criteria for REGEN-COV.
Who Is Eligible For This Treatment Under The EUA?
REGEN-COV is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults 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
Limitations of Authorized Use: Treatment
- REGEN-COV is not authorized for use in patients:
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
- Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
REGEN-COV is authorized in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
- not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
- have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) or
- who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)
Limitations of Authorized Use (Post-Exposure Prophylaxis)
- Post-exposure prophylaxis with REGEN-COV (casirivimab with imdevimab) is not a substitute for vaccination against COVID-19.
- REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19
REGEN-COV has not been approved, but has been authorized for emergency use by FDA
What Is Emergency Use Authorization (EUA)?
An EUA allows the U.S. Food and Drug Administration (FDA) to help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear (CBRN) defense threats by facilitating the availability and use of therapies needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.
I Tested Positive Somewhere Else, Can I Still Use Your Clinic For This Treatment?
If you meet the criteria for this treatment, yes you can. No matter where you received a positive test result, our office can help you treat you.
How Long Does The Treatment Take?
From start to finish, you can expect to be in our clinic 2 hours or less.