NEW: Information Sheet: Key Messages for Long Term Care Facilities
Effective January 2023, there is a new LTC Facility information sheet. The sheet includes the following information:
- COVID-19 Treatments are safe, effective, and widely available.
- Treatments should be considered for any patient over the age of 50 or with a high-risk health condition.
- Treatments must be started early, even if symptoms are mild.
- The oral antiviral pill Paxlovid (ritonavir-boosted nirmatrelvir) and the IV administered drug Veklury(remdesivir) are the preferred treatments for eligible patients.
- Lagevrio (molnupiravir) is an alternative oral antiviral for patients for whom neither Paxlovid nor Veklury are clinically appropriate or feasible.
- Long-term care facilities should ensure timely access to effective COVID-19 treatments for all eligible patients, including through pre-positioning the medications directly at facilities.
For the entire fact sheet, please visit COVID-19 Treatments: Information for Long Term Care Facilities.
NEW: Therapeutics Information Sheets
New Lagevrio Information Sheet
- Quick reference document for health care providers.
- Highlights patient eligibility and effectiveness information.
Updated as of January 2023: Paxlovid Information Sheet
- Quick reference document for health care providers.
- Highlights patient eligibility and effectiveness information.
Coming soon: Outpatient Veklury Information Sheet
- Quick reference document for health care providers.
- Highlights patient eligibility and effectiveness information.
Reminder: Variants and Evusheld Resistance Updates
On Friday, January 6th, FDA released important information about risk of COVID-19 due to certain variants not neutralized by Evusheld
- FDA is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 Omicron variant that is currently estimated to account for 28% [as of Jan. 6, 2023] of circulating variants in the U.S [Total resistance including XBB.1.5 is estimated at ~92%].
- Because of its similarity to variants that are not neutralized by Evusheld(e.g., XBB), FDA does not anticipate that Evusheld will neutralize XBB.1.5.
- This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, FDA is awaiting additional data to verify that Evusheld is not active against XBB.1.5.
- Further updates will be provided as new information becomes available.
- Health care providers should inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld.
On Tuesday, January 10th, NIH updated their statement regarding Evusheld here: Statement on Evusheld | COVID-19 Treatment Guidelines (nih.gov)
- In the US, the prevalence of subvariants likely to be resistant to tixagevimab plus cilgavimab (Evusheld) is more than 91%. Although tixagevimab plus cilgavimab is still authorized by the FDA for COVID 19 pre-exposure prophylaxis (PrEP), it is unlikely to be effective at preventing COVID 19 in the vast majority of individuals. However, no alternative options for PrEP are available, and clinicians could still administer tixagevimab plus cilgavimab after considering an individual patient’s risks and the regional prevalence of the resistant subvariants.
The Evusheld Fact Sheet has been updated to reflect in-vitro neutralizing data for several Omicron subvariants.
Refer to FDA releases important information about risk of COVID-19 due to certain variants not neutralized by EVUSHELD.
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. FDA is working on updating webpages to reflect extended dates.
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.
|
