IDStewardship

Bamlanivimab

Bamlanivimab Photo

16 April 2021 – Important Note

Today the FDA revoked the EUA for bamlanivimab monotherapy. The EUA for bamlanivimab-etesivimab remains standing.

29 March 2021 – Important Note

Bamlanivimab is not active against numerous circulating variants and has dropped out of favor. Details on this are provided in the Fact Sheet for Healthcare Providers.

Posted 15 February 2021. Note that this page may be rendered inaccurate as more data emerges. 

KEY POINTS

  • Bamlanivimab is a neutralizing IgG1 monoclonal antibody that binds to the receptor binding domain of the spike protein of SARS-CoV-2, which can reduce viral replication
    • Monoclonal antibodies are molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system’s attack on cells
    • Is a form of passive immunity
    • Not all SARS-CoV-2 monoclonal antibodies are active against all SARS-CoV-2 variants
  • Bamlanivimab is not FDA-approved for any indication
    • Was given Emergency Use Authorization (EUA) status from the FDA on 9 November 2020. It was approved for use in combination with etesevimab on 9 February 2021. The bamlanivimab monotherapy EUA was revoked on 16 April 2021.
      • EUA covered use by healthcare providers in an outpatient settings to treat mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization
      • FDA recommended giving within 10 days of symptom onset
      • Was not authorized to be given to:
        • Adults or pediatric patients who are hospitalized due to COVID-19
        • Adults or pediatric patients who require oxygen therapy due to COVID-19
        • Adults or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity
      • Data supporting the approval comes from the BLAZE-1 trial. It was studied in ACTIV-3 (in hospitalized patients) and no benefit was found. It is discussed here.
  • Associated with infusion-related reactions (fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness)
  • Can cause anaphylaxis and allergic reactions
  • Adverse reactions were to be reported to FDA Medwatch & Lilly
  • The approved dose was 700 mg in 200 mL NS IV once administered over 60 minutes
    • Lilly did not provide dose adjustments for renal or hepatic function
    • Was provided in 700 mg per 20 mL vials, to be stored under refrigeration and protected from light
      • Once diluted, could be stored for up to 24 hrs at refrigerated temperature, or 7 hours at room temperature (including infusion time)
      • If refrigerated, infusion solution should have been allowed to equilibrate to room temperature for ~20 minutes prior to administration
    • Patients were to be observed for an hour following the infusion
  • Not renally excreted or metabolized by cytochrome P450 enzymes
    • Drug-drug interactions with renally excreted drugs or substrates/ inducers/ inhibitors of cytochrome P450 enzymes are unlikely
  • CDC provides guidance on timing of antibody therapy and COVID vaccines here
  • For fun…

RESOURCES

RECOMMENDED TO YOU

 

Recent