Shelf-Life Extensions Help Preserve COVID-19 Medications
Pharmacists should be aware that some properly stored COVID-19 medications might be appropriate to use after the expiration date on labels. Why? Federal officials have extended shelf-life dates for several products in an effort to keep up THE supply of drugs effective against the SARS-CoV2 virus.
WASHINGTON, DC – Public health officials are continuing to announce shelf-life extensions for key medications to prevent and treat COVID-19.
At the end of June, the Department of Health & Human Service’s 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 specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab). The product is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in specific adults and children.
“As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry, and, as required by the emergency use authorization for Evusheld, unopened vials of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL 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.”
According to the update, this applies to all unopened vials of Evusheld that have been held in compliance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld
Public health officials advise that, while Evusheld has fixed expiration dates on the label of each vial and carton, those dates do not reflect the extended 24-month shelf-life.
The FDA also authorized an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, which are administered together or REGEN-COV.
“Due to the high frequency of the Omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region,” the advisory explained. “Therefore, REGEN-COV 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, the U.S. government recommends that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to REGEN-COV, emerge and become prevalent in the United States.”
The impetus for the extensions is to make sure ample supplies are available in future outbreaks. Past research suggests that medical products often remain safe and effective beyond their expiration date when proper storage is used.
In May, the shelf life of specific lots of bebtelovimab also was extended. The drug authorized for emergency use, had its shelf life extended from 12 months to 18 months. An update states that unopened medicine vials that have been stored continuously at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect them from light exposure can be kept and used for up to 6 months beyond their label expiration dates. For more information, see the ASPR website.
In June, an additional 150,000 doses of bebtelovimab were ordered by federal officials for use in treating patients who have been diagnosed with COVID-19 and are at high risk of hospitalization from the infection.
Administered as an injection, bebtelovimab is the only monoclonal antibody medication currently found to be effective for treating infections from the SARS-COV-2 omicron variant and sub-variants.
ASPR said the purchases “brings the total U.S. government purchase of bebtelovimab to 750,000 doses. This latest purchase and the doses available from previous purchases are expected to meet current demand levels through late August.”