Paxlovid Prescribing Complicated By Dosing Adjustment For Renal Impairment, Drug-Drug Interactions
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.
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While the Medicines Patent Pool has sub-licensed Paxlovid to multiple Indian firms, it isn’t approved in the country yet. It will get there, but molnupiravir’s sales might give an indication of what is in store for Pfizer’s oral antiviral COVID-19 treatment post a lost opportunity with vaccine Comirnaty.
After lengthy review, Merck’s antiviral gets very restricted indication as part of its EUA, apparently reflecting concerns over safety and efficacy. But molnupiravir does appear to have some advantages over Pfizer’s Paxlovid – including that more of it will be available in the short term.
Authorized for mild-to-moderate COVID-19 in patients 12 and older at high risk for severe disease, Paxlovid (nirmatrelvir/ritonavir) jumped ahead of Merck & Co./Ridgeback’s molnupiravir in the EUA queue for oral antivirals, with the latter possibly hung up by efficacy and safety concerns.