In this post I link to and excerpt from the FACT SHEET FOR HEALTH CARE PROVIDERS: EMERGENCY USE AUTHORIZATION (EUA) OF REGEN-COVTM (casirivimab and imdevimab) [Link is to the 56 page full PDF]. From the Federal Drug Administration.
The above resource details which persons are at increased risk of serious COVID-19 infections when exposed to persons with COVID-19 infection. And the resource recommends which COVID-19 exposed person should be treated with REGEN-COVTM.
All that follows is excerpted from the above resource:
AUTHORIZED USE
TREATMENTThe U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, 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 andolder 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
• REGEN-COV (casirivimab and imdevimab) is not authorized for use in patients:
– who are hospitalized due to COVID-19, OR
– who require oxygen therapy due to COVID-19, OR
o 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.
POST-EXPOSURE PROPHYLAXIS
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, REGEN-COV (casirivimab
and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab)
supplied as individual vials to be administered together, 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 vaccinated1 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 medications2) 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)3 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 thesame institutional setting (for example, nursing homes, prisons) [see Limitations of Authorized Use (1.2)].Limitation Of Authorized Use
- Post exposure prophylaxis with REGEN-COV (casarimivab and imdevimab) is not a substitute for COVID-19.
- REGEN-COV (casarimivab and imdevimab) is not authorized for pre-exposure prophylaxis.
1 Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series
(such as the Pfizer or Moderna vaccines), or 2 weeks after a single-dose vaccine (such as Johnson & Johnson’s
Janssen vaccine). See this website for more details: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fullyvaccinated.html#vaccinatedTreatment
This EUA is for the use of the unapproved product, REGEN-COV (casirivimab andimdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab)
supplied as individual vials to be administered together, for the treatment of mild to moderate 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 [see Limitations of Authorized Use (1.1)].Post-Exposure Prophylaxis
This EUA is for the use of the unapproved product, REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, 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 vaccinated1 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
medications2) and
– have been exposed to an individual infected with SARS-CoV-2
consistent with close contact criteria per Center for Disease Control
and Prevention (CDC)3 or
– who are at high risk of exposure to an individual infected with SARS-CoV2 because of occurrence of SARS-CoV-2 infection in other individuals in
the same institutional setting (for example, nursing homes, prisons) [see
Limitations of Authorized Use (1.2)].
Criteria for Identifying High Risk Individuals
The following medical conditions or other factors may place adults and pediatric patients
(age 12-17 years and weighing at least 40 kg) at higher risk for progression to severe
COVID-19:
• Older age (for example, age ≥65 years of age)
• Obesity or being overweight (for example, BMI >25 kg/m2
, or if age 12-17, have
BMI ≥85th percentile for their age and gender based on CDC growth charts,
https://www.cdc.gov/growthcharts/clinical_charts.htm)
• Pregnancy
• Chronic kidney disease
• Diabetes
• Immunosuppressive disease or immunosuppressive treatment
• Cardiovascular disease (including congenital heart disease) or hypertension
• Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma
[moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary
hypertension)
• Sickle cell disease • Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
• 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 and authorization of
REGEN-COV under the EUA 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, see the CDC website:
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medicalconditions.html. Healthcare providers should consider the benefit-risk for an individual
patient.
