FDA Expands Monoclonal Antibody Indications to Post Exposure Prophylaxis In Non-vaccinated Individuals
The use of Casirivimab/Imdevimab has been authorized for emergency use to treat mild to moderate COVID-19 in adult and pediatric patients with positive results of SARS-CoV-2 viral testing who are 12 years of age or older, weighing at least 40 kg, and who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Synergy Wellness has a limited supply/ability to administer this infusion. Our inclusion/exclusion criteria align with FDA guidelines.
Exclusion (any one of below excludes patient
from being a candidate for infusion)
- Hospitalized due to COVID-19
- Patient requires oxygen therapy due to COVID-19
- Weight < 40 kg
- >10 days from symptom onset
Positive COVID-19 PCR or Antigen test
AND one of below:
- Age ≥ 65
- BMI ≥ 25 (any age)
- Chronic kidney disease
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular Disease or Hypertension
- Chronic lung diseases
- Sickle cell disease
- Neurodevelopmental disorders
- Other conditions that confer medical complexity
- Having a medical-related technological dependence
- Other medical conditions or factors that may place patient at high risk for progression to
REGEN-COV may only be used 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 and have been exposed to an individual infected with SARS-CoV-2 or those 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.