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Paxlovid Prescribing Complicated By Dosing Adjustment For Renal Impairment, Drug-Drug Interactions

 
• By Sue Sutter

In the EUA for Pfizer’s COVID-19 oral antiviral treatment, US FDA required a reduced dose for some renally impaired patients that is ‘incongruent with how Paxlovid is packaged,’ meaning that pharmacists have to manually make changes to each blister pack. Prescribers will have to navigate an extensive list of contraindicated medicines due to CYP3A effects.

Paxlovid EUA dispensing information
Paxlovid dose modification instructions for renal impairment involve altering several blister packs and applying multiple trapezoidal stickers. • Source: Nielsen Hobbs; the Pink Sheet | Paxlovid EUA dispensing information

Safety concerns about dosing of Pfizer Inc.’s COVID-19 oral treatment Paxlovid in renally impaired patients, the two-drug combination’s packaging configuration and a host of potential drug-drug interactions resulted in a US Food and Drug Administration emergency use authorization with complex prescribing and dispensing instructions for some patients.

Reduced dosing for patients with moderate renal impairment will require pharmacists to manually make changes to the Paxlovid packaging, creating a potential risk for medication errors.

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