FDA Updates Guidelines for Monoclonal Antibody Therapy Treatment for COVID-19

Wednesday, August 25, 2021

COVID-19 monoclonal antibody (MAb) therapy drugs authorized by the FDA for emergency use (EUA) are available as an intravenous therapy at the ER at Blue Diamond, located at 9217 S. Cimarron Road (cross street Blue Diamond). The therapy takes approximately one hour to infuse, followed by monitoring for any side effects for another hour. The ER at Blue Diamond is open 24 hours a day, seven days a week.

MAb therapy is not a substitute for a COVID-19 vaccination.

ER at Blue Diamond

COVID-19 monoclonal antibody (MAb) therapy drugs authorized by the FDA for emergency use (EUA) are available at the ER at Blue Diamond.

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Criteria for Identifying High Risk, COVID+ 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:

  • BMI ≥ 25 adults
  • Cardiovascular disease
  • BMI ≥ 85th percentile for age/gender
  • Chronic Kidney Disease
  • Hypertension
  • Sickle Cell Disease
  • Diabetes
  • Chronic obstructive pulmonary disease/other chronic respiratory disease
  • Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control
  • Immunosuppressive disease or treatment
  • Congenital or acquired heart disease
  • Neurodevelopmental disorder (i.e. cerebral palsy)
  • Pregnancy
  • Age ≥ 65
  • Medical-related technological dependence (i.e. tracheostomy, gastrostomy, positive pressure ventilation not related to COVID)

The FDA updated its authorization guidelines in early August for emergency use of MAb therapy as a post-exposure measure to protect against COVID-19 in adults and pediatric patients (12 and older and weighing at least 40 kg) who are:*

  • At high risk for progression to severe COVID-19, including hospitalization or death, AND
  • Not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people 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).

It is important to note this therapy is intended to be used early in the disease course. Individuals may not qualify if they have had more than 10 days of symptoms, require oxygen therapy, or otherwise do not qualify as determined by the treating physician.

* https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19

+ https://www.fda.gov/media/145611/download