COVID-19 Monoclonal Antibody IV Therapy

Monoclonal antibodies are lab-created proteins that mimic the ones our bodies produce to fight viruses. The antibodies defend the body by blocking Covid-19 viruses from attaching to human cells.

Individuals would not be eligible for this treatment if they are:

Hospitalized for COVID-19
Requiring oxygen therapy due to COVID-19
Allergic to any of the ingredients in the medication

Patients receiving monoclonal antibody therapy will undergo an intravenous infusion.

The infusion itself takes about 20 minutes. Afterwards there is an hour-long period where patients are monitored. The entire process takes 2 hours.

In order to preserve the safety and comfort of our patients, we offer this treatment in a house call setting.

This EUA is for the use of the unapproved products, REGEN-COV (casirivimab and imdevimab) and Eli Lilly (bamlanivimab and etesevimab), to be administered together for the treatment of mild to moderate 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 progressing to severe COVID-19 and/or hospitalization [see Limitations of Authorized Use].

High risk is defined as patients who meet at least one of the following criteria:

• Have a body mass index (BMI) ≥35
• Have chronic kidney disease
• Have diabetes
• Have immunosuppressive disease
• Are currently receiving immunosuppressive treatment
• Are ≥65 years of age
• Are ≥55 years of age AND have
  -cardiovascular disease, OR
  -hypertension, OR
  -chronic obstructive pulmonary disease/other chronic respiratory disease.
• Are 12 – 17 years of age AND have
  -BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm, OR
  -sickle cell disease, OR
  -congenital or acquired heart disease, OR
  -neurodevelopmental disorders, for example, cerebral palsy, OR
  -a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
  -asthma, reactive airway or other chronic respiratory disease that requires daily medication for control

One possible side effect of monoclonal antibody therapy is an allergic reaction. These reactions typically only occur during infusion or soon after, and your care team will closely monitor for any signs of an allergic reaction. However, because an infusion reaction can also be delayed, contact your doctor immediately if you notice any of the following signs of an allergic reaction:

Fever and/or chills
Nausea
Headache
Shortness of breath
Low blood pressure
Wheezing
Swelling of lips, face or throat
Muscle aches
Hives or itchiness

The FDA approved monoclonal antibody therapy for emergency use in November of 2020. Monoclonal Antibody therapy has been tested extensively in a clinical trial setting. 70 percent of patients who took monoclonal antibody therapy supported their immune system, leading to the recovery of Covid-19 symptoms.

The FDA updated the EUA to include patients at high risk of developing severe symptoms who are not fully vaccinated, patients who have not had a substantial response to the vaccine, and patients at high risk of exposure to an individual who tested positive for Covid-19.

No. Monoclonal antibody treatment can be used as a preventative measure if you believe you have been exposed to COVID-19.

Yes. This is the monoclonal antibody treatment that the President received.