Related Materials:  Direct Ordering of Monoclonal Antibodies | Monoclonal Antibody Treatment Information for Providers and Facilities (Q&A) | Bamlanivimab plus Etesevimab Distribution Fact Sheet | Casirivimab and Imdevimab Distribution Fact Sheet | More Healthcare & Testing Guidance | All Guidance

Given the sustained increase in variants resistant to bamlanivimab alone, and availability of alternative authorized monoclonal antibodies, the U.S. government has stopped the distribution of bamlanivimab alone. In March 2021, CDPH stopped recommending bamlanivimab monotherapy, and on April 16, 2021, the FDA revoked the EUA for bamlanivimab monotherapy. (1)(2)

Additionally, bamlanivimab plus etesevimab is also no longer available or recommended for use in California due to sustained increases in the P.1 and B.1.351 variants, which are resistant to the bamlanivimab plus etesevimab, per in vitro susceptibility assays. (3)

The FDA recommends that health care providers in California instead use casirivimab plus imdevimab (i.e., REGEN-COV) therapy until further notice. Casirivimab plus imdevimab is an alternative monoclonal antibody therapy that is currently authorized for the same use as bamlanivimab plus etesevimab. Based on in vitro assay data currently available, casirivimab plus imdevimab is likely to retain activity against prevalent variants. All treatment sites can continue ordering casirivimab plus imdevimab from the authorized distributer using the direct ordering process.

For more information, please see these additional resources:

• Direct Ordering of Monoclonal Antibodies (ca.gov)

• Monoclonal Antibody Treatment Information for Providers and Facilities (ca.gov)

• Casirivimab and Imdevimab Distribution Fact Sheet (ca.gov)

• COVID-19 Treatment Guidelines (nih.gov)

• IDSA Guidelines on the Treatment and Management of Patients with COVID-19 (idsociety.org)

• COVID-19 Resources For Healthcare Providers | combatCOVID.hhs.gov

(1) HHS/ASPR – Public Health Emergency – Bamlanivimab update

(2) Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | FDA

(3) HHS/ASPR – Public Health Emergency – Bamlanivimab plus Etesevimab update

​Originally published on Decemeber 31, 2021