PAXLOVID (nirmatrelvir tablets; ritonavir tablets) is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
PAXLOVID is not authorized:
- For initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19.
- For pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
- For use for longer than 5 consecutive days.
The safety and effectiveness of PAXLOVID have not been established in pediatric patients (<18 years of age).
Clinical studies of PAXLOVID include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 14 CLINICAL TRIALS). Of the total number of participants in the pivotal trial randomized to receive PAXLOVID (N=1,120), 13% were 65 years of age and older and 3% were 75 years of age and older.