Shelf-Life Extension of Bamlanivimab and Etesevimab
On April 13th, the Food and Drug Administration (FDA) and the Assistant Secretary for Preparedness and Response (ASPR) issued a statement that the shelf-life of bamlanivimab and/or etesevimab is being evaluated. Providers can anticipate an additional update regarding shelf-life extension in early May 2022.
In the interim, all bamlanivimab and etesevimab vials may be retained until the shelf-life extension evaluation is complete, regardless of the current labeled expiry date or previously provided extension dates.
This recommendation applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F) detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.
Due to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. However, it is recommended that product be retained in the event that future COVID-19 variants emerge and become prevalent in the United States.
Shelf-Life Extension of Sotrovimab and Paxlovid
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Therapeutic
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Lot Number
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Extended Expiration Date
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Sotrovimab
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658W
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8/2022
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XV6W, Y74D, JP9Y, 287F
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10/2022
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287X, 432U, 433C, BX3T
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11/2022
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9W8S, A39T
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3/2023
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BD8F, BC9P, C86N, CC3D, CK9V, D74S
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4/2023
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J23C, JJ7J, J67D
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6/2023
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MJ8W, ME3Y, MJ8X, ME3Y, NM9X, NM6J, NX3P, PK8J
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7/2023
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RM3K, S63E, R97L, S94Y, TE4L
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8/2023
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Paxlovid
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FL4516, FL4517, FR7229
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10/31/2022
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|
FR9088
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11/31/2022
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Requests for Therapeutics in HPOP
Providers can now place requests for therapeutics products within HPOP. Providers can request any therapeutic product for which their facility is approved (monoclonal antibodies, oral antivirals, etc.).
Department of State Health Services (DSHS) will review all requests prior to approval and appropriate quantities will be ordered based on reported usage, total requests, and the amount of product available.
Please read the following DSHS communication or visit COVID-19 Therapeutics Providers (texas.gov) webpage to review the most up to date information. Providers needing assistance can reach out to therapeutics@dshs.texas.gov with their questions.
New Renal Dosing Package of Paxlovid Authorized by FDA
A new package presentation of the COVID-19 oral antiviral therapeutic Paxlovid has been authorized by the FDA. It contains the appropriate dosing for patients with moderate renal impairment: 150 mg nirmatrelvir and 100 mg ritonavir.
Each carton contains 20 tablets divided in 5 daily-dose blister cards. Each blister card contains 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each). Nirmatrelvir tablets and ritonavir tablets are supplied in separate blister cavities within the same child-resistant blister card.
Please see the updated provider Fact Sheet, Letter of Authorization, and Dear Healthcare Provider Letter.
This renal Paxlovid packaging will be available in HPOP for request by enrolled pharmacies this week. It is shipped in packages of five patient courses.
Sotrovimab No Longer Authorized for Use in Texas
On April 5, 2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases caused by the Omicron BA.2 variant to be above 50% in all U.S. Department of Health and Human Services (HHS) regions.
Due to this data, the use of sotrovimab is no longer authorized in any U.S. state or territory at this time. Sotrovimab distribution to all U.S. states and territories has been paused. The FDA has updated the Fact Sheet for sotrovimab to reflect product use restrictions.
Please use one of the alternative therapies for symptomatic, high-risk patients. Please read the following DSHS communication and visit DSHS Information for COVID-19 Therapeutic Providers webpage to review the most up to date information.
Providers should keep the sotrovimab properly refrigerated so it can be used if it is re-authorized for future variants.
Update to NIH Guidelines for Therapeutic Management of Nonhospitalized Adults
The National Institutes of Health has updated their guidance for therapeutic management in nonhospitalized adults with COVID-19.
The following bulleted points outlines the Panel’s recommendations for using these therapeutic interventions outside the hospital inpatient setting. The preferred therapies are listed in order of preference:
• Paxlovid
• Veklury (remdesivir)
Alternative Therapies for use ONLY when neither of the preferred therapies are available, feasible to use, or clinically appropriate. Listed in alphabetical order:
• Bebtelovimab
• Lagevrio (molnupiravir)
Notable Clinician Resources
HHS/ASPR leads two webinars for clinicians on alternating Fridays.
From 11:00 to noon central.
• COVID-19 Therapeutics Clinical Webinar
• Medical Professionals COVID-19 Roundtable
Email COVID19Therapeutics@HHS.gov for webinar links.
Outpatient Therapeutics Decision Aid (ASPR)
Paxlovid Potential Drug-Drug Interactions Resource (Pfizer)
COVID-19 Therapeutics Reporting In HPOP
A reminder about reporting in HPOP:
- Reporting should include product doses utilized since your last report date.
- Reporting IS NOT a cumulative total of all doses utilized to date.
Any inventory of sotrovimab, REGEN-COV, or bamlanivimab/etesevimab must be reported in in the TDEM/DSHS Portal (hospitals) and HHS TeleTracking (non-hospitals).
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