Paxlovid Emergency Use Authorization (EUA): The Food and Drug Administration (FDA) and the Washington State Department of Health (DOH) are alerting providers to changes to the EUA for Paxlovid, most recently updated July 6, 2022.
- State-licensed pharmacists are now authorized Paxlovid prescribers.
- New drug interactions and a viral RNA rebound study were added to the EUA and Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers.
- Adverse reactions during post-authorization use of Paxlovid have been identified, including immune system disorders, hypersensitivity reactions, gastrointestinal disorders, abdominal pain, nausea and general malaise. The DOH advises that “because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”
- In addition, Pfizer has updated the contraindications related to drug interactions with use of Paxlovid.
Evusheld dosing and shelf life: On June 29, the FDA revised the recommended adult and pediatric Evusheld doses to repeated dosing every six months, with doses of tixagevimab and cilgavimab if ongoing protection is needed. The FDA also extended the authorized shelf life from 18 months to 24 months for specific lots of Evusheld, as long as the batches are unopened and in compliance with storage requirements. The relevant lot numbers and extended expiration dates are listed in “Table 1” online here.
Additional resources, guidance and previous updates are available on WSHA’s 2022 COVID-19 Therapeutics webpage. For questions related to therapeutics or these resources, please reach out to the Washington State Department of Health Medical Countermeasure Team at firstname.lastname@example.org or WSHA Senior Director Tina Seery at email@example.com.