MONOCLONAL ANTIBODY INFUSION
IN CANTON & ANN ARBOR, MI

Criteria for administration of Monoclonal Antibody Treatment

• 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. We will only administer to adults in our clinic.
• 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. Generally given the limitation in supply we will give to the higher risk of BMI > 30
• Pregnancy (must discuss do not know what occurs to the fetus and risk of complications/possible teratogenicity is unknown at this time)
• Chronic kidney disease stage 3 or worse
• 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)

Priority will be given to unvaccinated or undervaccinated, which means those not up to date include those who are not vaccinated, have not completed their initial series i.e. 2 doses of Pfizer/Moderna or 1 dose of J & J. If past 5 months from primary series of vaccination with Pfizer or Moderna then should have a booster or considered as not up to date. Those with J & J, should have booster 2 months after primary vaccination to be considered up to date.

FDA Emergency Use Authorization only allows for one MAB currently which is Bebtelovimab.

Bebtelovimab is authorized for use under Emergency Use Authorization (EUA) 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, and
• for whom alternate COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.