Paxlovid has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 88 lbs) and the treatment of adults and pediatric patients (12 years of age and older weighing at least 88 lbs) with recent exposure to COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
If Paxlovid is appropriate, treatment should be initiated as soon as possible after COVID-19 diagnosis and within 5 days of symptom onset. Paxlovid is not for people that have a history of allergy to nirmatrelvir or ritonavir or other components of these drugs, and it is not for people taking certain other drugs. Paxlovid may cause side effects, some of which may be serious and unexpected. Learn more about Paxlovid on the manufacturer’s website, at https://www.covid19oralrx-patient.com, and review the patient and healthcare provider fact sheets for more information.
The emergency use of Paxlovid is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization revoked sooner.