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Reporting LAHAN Alerts

Coronavirus Disease 2019

COVID-19 Monoclonal Antibody Treatment


Introduction

The US Food and Drug Administration (FDA) recently issued emergency use authorizations (EUA) to make both bamlanivimab and casirivimab/imdevimab combination (Regeneron) monoclonal antibodies (MAb) available for clinical use (http://www.covid19treatmentguidelines.nih.gov/whats-new/). These MAbs are approved for the treatment of non-hospitalized patients with mild to moderate COVID-19 (with positive results of direct viral tests for SARS-CoV-2) who are at high risk for progressing to severe disease and/or hospitalization. Skilled Nursing Facilities (SNF) have been identified as settings where MAb treatment may be beneficial.

Clinical criteria for use of MAb
Inclusion Criteria Exclusion Criteria

Candidates are required to fit one of the following criteria:

  1. Positive PCR test for SARS-Cov-2; OR
  2. Positive SARS-Cov-2 antigen test + symptoms consistent with COVID-19

Candidates must also fit anyone of the following high-risk conditions:

  1. Have a body mass index (BMI) ≥35
  2. Have chronic kidney disease
  3. Have diabetes mellitus
  4. Have immunosuppressive disease
  5. Are currently receiving immunosuppressive treatment
  6. Are > 65 years of age
  7. Are ≥55 years of age AND have
    1. cardiovascular disease, OR
    2. hypertension, OR
    3. chronic obstructive pulmonary disease/other chronic respiratory disease
  8. High-risk patients aged 12-17 years may also be candidates for this therapy (http://pi.lilly.com/eua/bamlanivimab-eua-factsheet-hcp.pdf) Updated
    Please note the EUA fact sheet has been officially updated to reflect the elimination of the step to first withdraw 70 ml from the saline bag. This much simplifies the preparation of the drug.

Some patients are excluded from using the MAb product. The drugs may not be given if the patient meets any of the following criteria:

  1. Patients hospitalized due to COVID-19,
    OR
  2. Patients who require oxygen therapy due to COVID-19, OR
  3. Who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen
  4. Age <12 years
  5. Weight <40 kg.

*For more information see the NIH COVID-19 Treatment Guideline Panel Statements on the EUA of Bamlanivmab and Casiribimab Plus Imdevimab Combination for the Treatment of COVID-19

Additional requirement for SNFs providing MAb therapy:
  1. SNF must have licensed clinical staff present during the MAb infusion and for 1 hour afterwards.
  2. Because of the small risk of anaphylaxis with all MAb therapy, SNFs must have anaphylaxis kits available at all times.
  3. MAb treatment is urgent, not emergent, meaning the therapy should be provided during normal business hours when adequate clinical staff are available to support the infusion process.
Ordering and Procuring MAb

As pharmacies need to prepare the infusions in advance, LAC DPH has been consulting with SNF pharmacists on the best ordering and procurement processes to keep a supply stocked for SNFs when their residents meet the clinical criteria for MAb. 

  1. SNFs who wish to provide MAb to their residents should contact their pharmacy to obtain the drug.
    A list of pharmacies that currently stock the drug is below.
  2. If your pharmacy does not carry the drug, they should submit a resource request to Emergency Medical Services Agency (EMSA) directly by following the instructions below.
Instructions for EMSA MAb Requests by SNF Pharmacies:
  1. To order your initial allocation of 25 doses of Bamlanivimab (and subsequently Regeneron when available), submit a Resource Request to EMSA. Access the Resource Request form here: http://file.lacounty.gov/SDSInter/dhs/243593_FRM-ResourceRequestMedicalandHealth-20140814.xlsx
  2. Instructions on completing the Resource Request form:
    1. Section 1 – Incident Name-- insert “Covid-19
    2. Section 3 – Insert your pharmacy info
    3. Section 4 – Describe Mission Task--insert “Administer MAbs to residents meeting criteria”
    4. Section 6 –Medical & Health Request Details
      1. Priority-insert “U”
      2. Detailed Specific Item Description –insert “Bamlanivimab” (or “Regeneron” when available)
      3. Qty – insert “25 doses” (this is for the initial allocation. For subsequent requests, indicate the number of doses you need).
    5. Email the completed form as an attachment tolaemsadutyofficer@dhs.lacounty.gov
  3. The EMSA will notify the requesting pharmacy when the product is available (within 1 business day) for pick up from the warehouse located at 10430 Slusher Drive, Santa Fe Springs, Los Angeles, CA 90670, M-F 8 AM-4:30 PM. If you have any questions about pick-up, please call (562) 378-2444 (primary) or (562) 378-2445 (back-up).
  4. If you need additional doses of the monoclonal antibodies, please submit another resource request as outlined in steps 1 and 2 above.
List of SNF Pharmacies which currently have available MAb
Either Bamlanivimab or Regeneron
  1. Del Pharmacy 10374 Trademark St., Rancho Cucamonga, CA 91730 909-477-6300
  2. Med-Plus Pharmacy 277 E Rowland St. Covina, CA 91733 (626) 712-5336
  3. Premiere Pharmacy Services 410 Cloverland Dr. Baldwin Park, CA 91706 (818) 259-4842
  4. Omnicare of Cerritos 13825 Cerritos Corp Dr. Cerritos, CA 90703 (562) 202-8549
  5. Omnicare of Southern California 8220 Remmet Ave. Canoga Park, CA 91304 (562) 378-1703


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  • Public Health has made reasonable efforts to provide accurate translation. However, no computerized translation is perfect and is not intended to replace traditional translation methods. If questions arise concerning the accuracy of the information, please refer to the English edition of the website, which is the official version.

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