“Mabs” for COVID-19: Patient Assessment and Referral

Monoclonal antibodies “mabs” are authorized in certain outpatients with a high-risk condition and mild to moderate COVID-19. Use of a “mab” infusion may prevent progression to severe COVID-19 when given early in the infection. Use this algorithm to help identify appropriate patients for potential use.

Initial assessment:1-4

  • Does the patient have a documented positive test for COVID-19?
    • If YES, continue to the next question.
    • □ If no, the patient does not qualify for a COVID-19 monoclonal antibody.
  • Is the patient at least 12 years old?
    • If YES, continue to the next question.
    • □ If no, the patient does not qualify for a COVID-19 monoclonal antibody.
  • Does the patient weight at least 88 pounds (40 kg)?
    • If YES, continue to the next question.
    • □ If no, the patient does not qualify for a COVID-19 monoclonal antibody.
  • Does the patient have mild or moderate symptoms that started no more than 10 days ago?
    • If YES, continue to the next question.
    • □ If no, the patient does not qualify for a COVID-19 monoclonal antibody.
  • Does the patient require supplemental oxygen (or more oxygen than baseline use due to COVID-19 symptoms)?
    • If NO, continue to the next question.
    • □ If yes, the patient does not qualify for a COVID-19 monoclonal antibody.
  • Does the patient require hospitalization, based on severity of COVID-19 symptoms?
    • If NO, continue to the next section to see if the patient has a qualifying high-risk condition?
    • □ If yes, the patient does not qualify for a COVID-19 monoclonal antibody.

Does the patient have at least ONE of the following high-risk conditions?1-4 (If YES, patient qualifies.)

  • For all patients who qualify based on the initial assessment above:
    • □ body mass index (BMI) ≥35 kg/m2
    • □ chronic kidney disease (CKD)
    • □ diabetes (type 1 or type 2)
    • □ immunosuppressive disease
    • □ immunosuppressive treatment
    • □ ≥65 years old
    • □ ≥55 years old AND one of the following:
      • cardiovascular disease
      • hypertension
      • chronic obstructive pulmonary disease
      • other chronic respiratory disease
  • For patients between 12 and 17 years old, must meet ≥1 criterion from the list above OR below:
    • □ body mass index (BMI) ≥85th percentile based on CDC growth chart
    • □ sickle cell disease
    • □ congenital or acquired heart disease
    • □ neurodevelopmental disorders
    • □ medical technology dependence (e.g., tracheostomy, gastrostomy, Positive Pressure Ventilation not related to COVID-19)
    • □ asthma or reactive airway disease
    • □ other chronic respiratory disease requiring daily medications for control

Help patients make an informed decision about receiving “mab” treatment.

  • Explain the possible benefit (reducing the risk of progression to a severe COVID-19 infection) and risks associated with monoclonal antibody treatment.
    • □ Allergic reactions (e.g., fever, chills, shortness of breath, wheezing) are rare.1 However, explain to patients that they will need to be observed for about one hour after completing the monoclonal antibody infusion (which can take up to one hour) to monitor for a possible reaction.5
  • Make sure patients understand that treatment with a monoclonal antibody does not cure COVID-19.1
    • □ Advise patients they will need to continue to use infection control measures and isolate according to current health department guidance.1
  • There are not enough data available to assess possible risks associated with use of monoclonal antibodies in pregnant or lactating mothers. Discuss with patients individually. Only use monoclonal antibodies when the potential benefit (reduced disease severity) outweighs the risks (unknown).1-4

What monoclonal antibody dose should be used to treat mild or moderate COVID-19?

  • Monoclonal antibodies for mild to moderate COVID-19 are one-time intravenous (IV) infusions.2-4
    • □ bamlanivimab:2 700 mg (Note as of March 24, 2021 the mfr will no longer ship bamlanivimab alone due to increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab monotherapy.)6
    • □ bamlanivimab/etesevimab:3 700 mg/1,400 mg
    • □ casirivimab/imdevimab:4 1,200 mg/1,200 mg
  • For details about administration or other information, refer to the specific emergency use authorization (EUA) document for each product. EUAs can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.

Where can patients receive monoclonal antibody infusions for COVID-19?

References

  1. American Pharmacists Association. Pharmacists’ referrals for monoclonal antibody treatment: assessing patients for potential COVID-19 treatment with monoclonal antibodies. February 25, 2021. https://www.pharmacist.com/sites/default/files/audience/APhACOVID-19MAB0221_web.pdf. (Accessed March 18, 2021).
  2. FDA. Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Revised March 18, 2021. https://www.fda.gov/media/143603/download. (Accessed March 18, 2021).
  3. FDA. Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Revised March 18, 2021. https://www.fda.gov/media/145802/download. (Accessed March 18, 2021).
  4. FDA. Fact sheet for health care providers: emergency use authorization (EUA) of casirivimab and imdevimab. March 2021. https://www.fda.gov/media/145611/download. (Accessed March 18, 2021).
  5. HHS ASPR TRACIE. Planning considerations for monoclonal antibody administration. Updated February 10, 2021. https://files.asprtracie.hhs.gov/documents/aspr-tracie-covid-19-monoclonal-antibody-therapy-tip-sheet.pdf. (Accessed March 18, 2021).
  6. U.S. HHS/Public Health Emergency. Update on COVID-19 variants and impact on bamlanivimab distribution. March 24, 2021. https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab/Pages/default.aspx. (Accessed March 25, 2021).

Cite this document as follows: Clinical Resource,“Mabs” for COVID-19: Patient Assessment and Referral. Pharmacist’s Letter/Prescriber’s Letter. April 2021. [370402]