COVID-19 Monoclonal Antibody (mAb) Treatment and Post-Exposure Prophylaxis (PEP) Referral
PROVIDER REFERRAL ONLY
Guthrie may utilize any monoclonal antibody product with FDA Emergency Use Authorization (EUA) that is active against SARS-CoV-2 variants circulating in our region at the time. At this time the Omicron variant is likely becoming the most prevalent and therefore we will be utilizing Sotrovimab (GlaxoSmithKline) which is the most effective product for this strain. As the most prevalent strains may change over time we may use casirivimab and imdevimab (Regeneron), bamlanivimab and etesevimab (Eli Lilly) based on efficacy versus various strains. These drugs will be administered in a designated Guthrie outpatient center via sub-Q injection or IV infusion followed by a 30 minute observation period (~total time 1.5 -2.5 hours).
We require that the referring clinician:
- Discuss the treatment with the patient
- Provide the FDA fact sheets on the monoclonal antibody medications for the patient, and
- Obtain the patient’s approval to receive the monoclonal antibody injection/infusion should drug be allocated to them via the selection process. If the patient does not agree to receive this treatment, continue your plan of care and do not submit a referral form.
For patients who are eligible to receive drug, a centralized team will contact the patient to schedule an infusion or sub-Q injection. There is high demand for this treatment. Referring patients earlier in the symptom window is recommended.
The FDA EUA requires the patient to meet the following for mAb treatment:
- Positive PCR or Antigen test for COVID-19
2. Mild to moderate COVID-19 symptoms for 10 days or less (patient must still be symptomatic and within the established timeframe to at time of monoclonal antibody treatment). If symptoms have resolved, do not refer the patient for treatment
3. The patient CANNOT have a new or increasing oxygen requirement above stable baseline oxygen support
4. Be at high risk of progressing to severe COVID19 (AT LEAST ONE of the following):
- Age >65 years
- Adolescent aged 12* and older weighing at least 40kg or adults 18 years or older, with one of the following conditions
- BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts.
- Chronic kidney disease
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular diseases (e.g. congenital heart disease or hypertension)
- Chronic lung disease (e.g. chronic obstructive pulmonary disease, asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (e.g. cerebral palsy, genetic or metabolic syndromes, severe congenital abnormalities)
- Having a medical-related technological dependence (e.g. tracheostomy, gastrostomy, positive-pressure ventilation (not related to COVID-19)
This clinic prioritizes patients at highest risk. At this time, we are concentrating our supply on patients in tier 1, tier 2 and as able, tier 3.