 Repeat EVUSHELD dosing now recommended for continued protection
On June 29, 2022, the FDA revised the EVUSHELD Fact Sheet for Healthcare Providers to recommend repeat dosing every 6 months(300mg of tixagevimab/300mg cilgavimab) for ongoing protection. This is new information as the previous fact sheet did not provide a specific recommendation on the dosing interval.
A note about EVUSHELD and circulating variants:
The FDA continues to monitor the neutralizing activity of EVUSHELD against emerging SARS-CoV-2 variants, and data suggests that activity against the currently circulating subvariants is retained for 6 months at drug concentrations achieved following an EVUSHELD dosing. The FDA will provide additional updates as required.
EUA Updates: Paxlovid
On June 29th, the FDA also updated Paxlovid’s EUA, with information related to viral RNA rebound.
- post-treatment increases were observed on day 10 and/or day 14 in a subset of paxlovid AND placebo recipients, regardless of symptoms
- this was not associated with hospitalization or death
- also not associated with drug resistance
- a similar or smaller percentage of placebo recipients experienced viral RNA rebound
- the clinical relevance of increases in viral RNA are unknown
For more in depth information, see Fact Sheet for Healthcare Providers: EUA for Paxlovid
On July 6th, the FDA made additional revisions to the EUA, to authorize state-licensed pharmacists to prescribe Paxlovid, with certain limitations to ensure appropriate patient assessment and prescribing.
The Board of Pharmacy has confirmed that pharmacists are authorized to prescribe Paxlovid per the Paxlovid EUA. You do not need to wait for a state protocol to prescribe Paxlvoid as this is authorized per the 9th amendment of the PREP Act. Please note that pharmacists are only able to prescribe Paxlovid if the following conditions are met:
1) Health records less than 12 month old are available to assess renal and hepatic function, AND
2) A comprehensive medication list (OTC and Rx) is available to assess drug-drug interactions
Pharmacists should not prescribe Paxlovid and instead refer patients to their primary care provider if the above criteria cannot be met, if a drug-drug interaction must be resolved with modification of another medication or if the patient is not eligible for Paxlovid.
Attn Pharmacists: FAQ related to NPI numbers
- Why do I need an NPI number?
An NPI number is required for a healthcare provider covered under the Health Insurance Portability and Accountability Act (HIPAA) to transmit any health information in an electronic form between two parties to carry out financial or administrative activities related to healthcare. The individual pharmacist must have an individual NPI as the pharmacist is acting on behalf of themselves, rather than the behalf of the pharmacy. Individual health care providers receive a Type 1 NPI number and health care organizations, such as pharmacies, receive a Type 2 NPI number.
- How do I obtain an NPI number?
Pharmacists may visit the National Plan and Provider Enumeration System to register for an NPI number. There is no cost to the provider to obtain an NPI number.
EVUSHELD Shelf-life Extension
On June 28, 2022, the Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) announced the authorization of an extension to the shelf-life from 18 months to 24 months for the specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, EVUSHELD (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals.
As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 below) and, as required by the emergency use authorization for EVUSHELD, unopened vials of EVUSHELD (150 mg/1.5 mL of tixagevimab and 150 mg/1.5mL of cilgavimab), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. FDA granted this extension following a thorough review of data submitted by AstraZeneca. This extension applies to all unopened vials of EVUSHELD that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Heatlh Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for EVUSHELD.
EVUSHELD has fixed expiration dates on the label of each vial and carton. The date identified on the vial and carton reflects the original shelf-life of 18 months and does not reflect the extended 24-month shelf-life. The table below provides a list of the updated expiry, by batch, for distributed EVUSHELD. If the batch number on the vial/carton is not included in this listing, the product is labeled with the correct expiration date. If this changes or more lot numbers are added to this list of extended expirations we will provide that information as it becomes available.
Note: one lot was NOT INCLUDED in the EVUSHELD shelf-life extension: AZ2200491, “lot 12” will still expire August 31,2022.
Table 1: Extended Expiry Dating for EVUSHELD (Tixagevimab Co-Packaged with Cilgavimab) Authorized under EUA 104
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