COVID-19 cases are on the rise. The U.S. Food and Drug Administration granted emergency use authorization for REGEN-COV™ (casirivimab and imdevimab) 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. The Regeneron cocktail has efficacy against the currently predominant delta variant.
Is REGEN-COV right for your patients?
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
Monoclonal antibody treatment should be considered in outpatients who:
- Have been diagnosed with COVID-19 not severe enough to warrant admission, and who are at risk for progression to more severe disease
- Older age (for example, age >65 years of age)
- Obesity or being overweight (for example, BMI >25kg/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
- Chronic kidney disease
- 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.
It is important to remember that authorization of REGEN-COV under the EUA is not limited to the medical conditions or factors listed above. Health care providers should consider the benefit-risk for an individual patient.
Ministries in Southern California providing monoclonal antibodies:
Los Angeles County
Providence Saint John’s Health Center, Santa Monica (Emergency Department and 901 Wilshire Blvd. clinic)
Providence Saint Joseph Medical Center, Burbank (Emergency Department)
Facey Medical Group, Mission Hills (Immediate Care)
Facey Medical Group, Valencia (Immediate Care)
Providence St. Jude Medical Center, Fullerton (Emergency Department)
Providence Mission Hospital, Mission Viejo (Emergency Department)
Providence St. Joseph, Orange (Emergency Department)