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

Inclusion:
Positive COVID-19 PCR or Antigen test

AND one of below:

  • Age ≥ 65
  • BMI ≥ 25 (any age)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • 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
    severe COVID-19

Post-Exposure Prophylaxis:

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.

If you have a patient that meets criteria, please call (256)759-9167 during normal business hours. If it is after business hours, please call (256) 603-5651 with the patient’s name, DOB, and phone number. If you cannot reach anyone at either number, please forward the information to [email protected]. Inform the patient that they may be contacted by the clinic to schedule an appointment.