Important Update: FDA Authorizes Shelf-Life Extension for Bamlanivimab
On May 4, 2022, the FDA authorized an extension to the shelf-life from 18 to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bamlanivimab.
This extension applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions (2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers.
Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency.
However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the U.S.
Please contact COVID19Therapeutics@hhs.gov with any questions regarding this shelf-life extension.
To review the shelf-life extension for specific lots of Sotrovimab and Paxlovid please see the table below:
|
Therapeutic
|
Lot Number
|
Extended Expiration Date
|
|
Sotrovimab
|
658W
|
8/2022
|
|
XV6W, Y74D, JP9Y, 287F
|
10/2022
|
|
287X, 432U, 433C, BX3T
|
11/2022
|
|
9W8S, A39T
|
3/2023
|
|
BD8F, BC9P, C86N, CC3D, CK9V, D74S
|
4/2023
|
|
J23C, JJ7J, J67D
|
6/2023
|
|
MJ8W, ME3Y, MJ8X, ME3Y, NM9X, NM6J, NX3P, PK8J
|
7/2023
|
|
RM3K, S63E, R97L, S94Y, TE4L
|
8/2023
|
|
Paxlovid
|
FL4516, FL4517, FR7229
|
10/31/2022
|
|
FR9088
|
11/31/2022
|
Timing of COVID-19 Vaccination & Therapeutics
No delay is required before COVID-19 vaccination after a patient has received COVID-19 therapeutics for either treatment or pre-exposure prophylaxis.
If a patient has received monoclonal antibodies or oral antiviral medications to treat a COVID-19 illness, defer vaccination of people with known current SARS-CoV-2 infection until the person has recovered from acute illness and until criteria have been met for them to discontinue isolation.
To learn more about COVID-19 Vaccine Indications, visit https://www.cdc.gov/vaccines/covid-19/hcp/faq.html#vaccine-indications.
NOTE: Before administering EVUSHELD, confirm if your patient has received a COVID-19 vaccine within the past two weeks. If your patient has received a COVID-19 vaccine, EVUSHELD should not be administered until at least two weeks after vaccination.
Updated Paxlovid Resources
For more information about Paxlovid or to view updated resources please visit the following webpages:
Reminder: Renal Dosing Package of Paxlovid in HPOP
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. For Medical Information about PAXLOVID, please visit www.pfizermedinfo.com or call 1-800-438-1985.
This renal Paxlovid packaging is now available in HPOP for request by enrolled pharmacies. It is shipped in packages of five patient courses. Please be sure to report the administration and inventory data on the appropriate line in HPOP; the standard Paxlovid packaging and the renal Paxlovid are reported separately.
Reminder: Requests for Therapeutics in HPOP
Providers should place requests for therapeutics products in 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.
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 weekly in the TDEM/DSHS Portal (hospitals) or HHS TeleTracking (non-hospitals).
Reminder: Updates in HPOP
-
NEW Renal Paxlovid Code Available:
- The Renal Paxlovid NDC code in HPOP has been changed to the carton code 0069-1101-20
- Two-Factor Authentication issue has been fixed. Providers can now choose different authentication methods when they log in
- NPI Numbers can now be edited/entered by Providers and Partners
- Renal Paxlovid Therapeutic Inventory reporting now available
- Lot number and expiration dates are now mandatory in Wastage reporting
- There is now a notification of upcoming license expiration for providers
Reminder: FDA Approves First COVID-19 Treatment for Young Children
On April 25th, the U.S. Food and Drug Administration (FDA) expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (7lbs) with positive results of SARs-CoV-2 viral testing, who are:
- Hospitalized, or
- 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 (remdesivir) is not under allocation by the US HHS or the states. It is available for commercial purchase for outpatient use from distributors through your facility’s normal procurement process. Please see CMS COVID FAQs for Veklury reimbursement information: https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf, (page 146, question 3).
Please visit the Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children | FDA webpage to review the most up to date information.
Reminder: CDC Health Advisory Available for Therapeutic Treatment and Recommendations
On April 25th, The Centers of Disease Control and Prevention (CDC) issued a Health Advisory to update healthcare providers, public health departments, and the public about the availability and use of recommended therapies for COVID-19 and to advise against using unproven treatments that have known or potential harms for outpatients with mild to moderate COVID-19.
Recommended therapeutic treatments are available. There is no shortage of oral antiviral medications and providers may write prescriptions to be filled at any of more than 2,500 pharmacies that carry oral antivirals – including 176 Test to Treat sites across Texas.
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