NEW: Evusheld Not Currently Authorized for Use in U.S
Effective January 26, 2023, Evusheld is no longer authorized for use in the United States. Data show that Evusheld is unlikely to be active against more than 90% SARS-CoV-2 variants that are currently circulating, according to the most recent CDC COVID-19 Data Tracker: Variant Proportions.
- The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future.
- Retained product must be appropriately held in accordance with storage conditions detailed in the Fact Sheet authorized for Health Care Providers and the Letter of Authorization.
Please visit the The U.S. Food and Drug Administration's website (FDA) and view ASPR’s information sheet for additional details. You may also contact ASPR at COVID19Therapeutics@hhs.gov should you have questions.
For provider communication, please see DSHS Therapeutic Communication and DSHS Information for COVID-19 Therapeutics for current information.
NEW: FDA EUA Revision for Paxlovid and Lagevrio
On February 1, 2023, the FDA authorized revisions to the Paxlovid and Lagevrio EUA.
Paxlovid revisions:
- Removal of requirement of SARS-CoV-2 viral testing.
- The FDA recognizes that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment with Paxlovid for COVID-19 is appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high-risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the authorization are met, as detailed in the Fact Sheet for Healthcare Providers. The Agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19.
- Also revised to include new information on drug-drug interactions, specifically verapamil.
Lagevrio revisions:
- Mandatory Requirements Box, Use in Specific Populations (Section 8.1): Updates to pregnancy registry information.
- Dosage and Administration (Section 2.3) Addition of preparation and administration instructions via nasogastric and orogastric tube.
- Microbiology (Section 12.4): Addition of Omicron subvariants.
- Toxicology (Section 13.1): Updated.
- Removal of requirement of SARS-CoV-2 viral testing.
- The FDA recognizes that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment with Lagevrio for COVID-19 is appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high-risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the authorization are met, as detailed in the Fact Sheet for Healthcare Providers. The Agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19.
- Also revised to include new information on drug-drug interactions, specifically verapamil.
Updates sheets here: Lagevrio EUA; Paxloivd EUA.
NEW: CDC Morbidity and Mortality Weekly Report (MMWR) : Immunocompromised Persons and Circulating Variants
More than 90% of circulating SARS-CoV-2 variants in the U.S. are unlikely to be susceptible to Evusheld.
- COVID-19 vaccination remains the most effective way to prevent SARS-CoV-2–associated serious illness, hospitalization, and death.
- Despite evidence of vaccine effectiveness, coverage with the bivalent booster dose across the U.S. remains low.
- Among persons who are immunocompromised, their household members, and close contacts, prevention measures should be considered in addition to receipt of a bivalent booster dose.
- Persons with mild to moderate symptoms of COVID-19 who 1) are aged ≥50 years, 2) have an underlying health condition or 3) are unvaccinated are at risk for severe COVID-19–associated outcomes.
Please visit Morbidity and Mortality Weekly Report (MMWR) for more information.
NEW: Therapeutics Locator Tool to Include Outpatient Veklury(remdesivir) Providers
HHS has begun an initiative that will allow visibility of Veklury outpatient infusion sites on the HHS COVID-19 Therapeutics Locator to assist in matching patients at high risk of severe COVID-19 to the medications that can prevent disease progression.
- HHS requesting healthcare partners who order Veklury (remdesivir)for outpatient use to support improved public awareness and product access.
- Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider:
- Only information provided by the infusion site will be visible on the locator.
- Infusion sites can opt out of being on the locator at any time.
- Minimal engagement from the infusion sites required for their site to be shown on the locator.
If you want to have your site listed on the Outpatient Veklury (remdesivir) Locator, please click here to provide your information.
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.
Additional Shelf-Life Extension for Paxlovid:
On December 21st, FDA authorized an additional extension to the shelf life from 18 months to 24 months for certain lots of Paxlovid.
- As required by the emergency use authorization, unopened cartons of Paxlovid (300 mg nirmatrelvir and 100 mg ritonavir, or 150 mg nirmatrelvir and 100 mg ritonavir), must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers.
- FDA granted this extension following a thorough review of data submitted by Pfizer. To find the expiry date extension on your product, please download the data tables found on ASPR's website.
For up to date information on expiration dates, please visit: Important Updates | HHS/ASPR and Expiration Dating Extension | FDA:
Maintain all monoclonal antibodies under proper refrigerated temperatures, even if they are not currently authorized for use. It is possible that monoclonal antibodies will be authorized again in the future for use against new strains of SARS-COV2.
Update - No additional shelf-life extension is possible for etesevimab:
- Refer to online resources to determine true expiration date for etesevimab and bamlanivimab vials.
- Product can be returned for destruction as a bam/ete patient course using expired ete with matching bam vial of earliest expiration date (patient course = 2 vials ete, 1 vial bam).
NOTE: ASPR continues to work with product manufacturers to maximize shelf-life. We will provide any updates for upcoming expiration dates as soon as we receive.
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