Reminder: Monoclonal Antibody Treatments Available
By David Doolittle

COVID-19_HIV_Advisory

The rollout of COVID-19 vaccines and their distribution, along with the spread of variant strains of the underlying virus, have dominated recent news about the illness.

But don’t forget: Patients 12 years and older with mild to moderate symptoms who are at risk for severe COVID-19 disease are eligible to receive monoclonal antibody treatments provided by the federal government.

The Food and Drug Administration (FDA) in November approved emergency use authorizations (EAUs) for Eli Lilly and Co.’s bamlanivimab and Regeneron’s antibody cocktail of casarivimab and imdevimab. The treatments have been shown to reduce SARS-CoV-2 virus levels and to decrease risk of hospitalization due to COVID-19, health officials have said

Texas created a Therapeutics Finder Map to assist physicians in locating facilities that are distributing the treatments. Physicians must contact the institutions directly to determine availability and to arrange for any infusion. Outpatient facilities are also encouraged to register with register online to receive and administer the antibody therapies.  

Facilities will provide the treatments free of cost, but can charge an administration fee. Visit the Centers for Medicare & Medicaid Services website for coding and billing information. 

In addition, administered doses must be reported through ImmTrac2, the state’s vaccine registry. Facilities also should report the number of doses administered daily, state health officials have said. 

The Centers for Disease Control and Prevention (CDC) recommends that people who have received monoclonal antibody treatments should wait at least 90 days before receiving a COVID-19 vaccine. The 90-day delay should be taken “as a precautionary measure until additional information becomes available, to avoid potential interference of the antibody therapy with vaccine-induced immune responses,” CDC said.

Additional treatment information:

  • The antibody therapy should be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset. 
  • The products are not authorized for use in hospitalized COVID-19 patients, nor patients who require oxygen therapy, or who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
  • The treatments must be administered via a one-hour infusion process, and patients must stay onsite after infusion to check for hypersensitivity reaction.  
  • Facilities must report all medication errors and severe adverse reactions to FDA MedWatch. No additional post-treatment reporting is required.  

Find more tools, resources, and information on TMA’s COVID-19 Resource Center, which is continually updated.

Last Updated On

August 11, 2021

Originally Published On

December 18, 2020