Updated Bebtelovimab Fact Sheet and Omicron Subvariants Update
On November 4th, there was an update to the Bebtelovimab Fact Sheet Update: Clinical Pharmacology, Microbiology (12.4): updated neutralizing data
Bebtelovimab is not active against BQ.1, BQ.1.1; activity confirmed against BF.7, BA.2.75.2
FDA Statement: FDA Updates on Bebtelovimab | FDA
NIH updated statement on Omicron Subvariants specifically related to Bebtelovimab here: Statement on Omicron Subvariants | COVID-19 Treatment Guidelines (nih.gov)
- At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Prescribers should monitor CDC regional variant frequency, particularly Omicron subvariants BQ.1 and BQ.1.1.DSHS will send notification to providers if the authorization changes for any COVID-19 therapeutic products. Please also see ASPR Important Updates.
- There are several treatments authorized or approved which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1.
- Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg)
- Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are: hospitalized, or not hospitalized
- Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
Reminder: Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency.
Lagevrio Order Quantity Change in HPOP
Starting November 7th, Lagevrio orders greater than 15 will no longer need to be in multiples of 15.
- The minimum is still 15 patient courses
- You may order any number of courses above 15 (such as 16 or 40)
All COVID Monoclonal Antibodies Therapeutic Reporting to HPOP
The TeleTracking system has been the tool for reporting COVID-19 therapeutics inventory and utilization data for COVID-19 older therapeutics (casirivimab/imdevimab, bamlanivimab/etesevimab, and sotrovimab) since March 2020. As of November 2, 2022 report all COVID-19 therapeutics in HPOP portal. You will no longer report therapeutics in TeleTracking or TDEM portal. Please email Therapeutics@dshs.texas.gov
- If your facility does NOT have an HPOP account
- If you do not have monoclonal antibodies selected as an option for your facility and need to report these older products
This change will consolidate therapeutic reporting for all products and ordering in one system. Therapeutic data remains important to the federal response and is needed for tracking purposes and strategic decision making to provide more accurate and rapid support to the across the country.
HHS hospital data reporting guidance here: COVID-19 Hospital Data Reporting Guidance Update
Reminder: Shelf-Life Extensions
ALL COVID-19 therapeutics have received extensions for some or all lots. Please check with the manufacturer before removing any products from the proper storage conditions.
Please find an addition listing of expiration extensions from the FDA here.
Maintain all monoclonal antibodies under proper refrigerated temperatures, even if they are not currently authorized for use. It is expected that will be authorized again in the future for use against new strains of SARS-COV2.
Veklury (remdesivir) - Outpatient Use
FDA approved expanded use of Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for treatment of mild-to-moderate COVID-19 disease (Jan 21, 2022), including:
- Adults and pediatric patients 28 days of age and older and weighing at least 3 kgwithpositive results of direct SARS-CoV-2 viral testing, AND
- Who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death
Veklury is the only COVID-19 therapeutic treatment available for patients under 12 years of age.The treatment course of Veklury (remdesivir) should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and must be within 7 days of symptom onset.The recommended total duration of treatment for non-hospitalized patients is 3 days.
Procurement/Ordering:
Commercially available through Gilead Pharmaceuticals: https://www.gilead.com/remdesivir
Veklury is available through multiple distributors. For additional information regarding purchasing or how to access Veklury (remdesivir), email remdesivir@amerisourcebergen.com, call 1-800-746-6273 or reach out directly to your AmerisourceBergen, Cardinal, or McKesson representative.
More on Velkury here: Velkury(remdesivir) HCP Website
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