FDA

The FDA issued an Emergency Use Authorization (EUA) for the emergency use of Paxlovid (nirmatrelvir/ritonavir) for the treatment of mild-to-moderate COVID-19 disease in adults and pediatric (≥ 12 years of age) who are at high risk for progressing to severe COVID-19 illness, including hospitalization and death.

• Risk factors for severe disease include diabetes, overweight (BMI >25), chronic lung disease, chronic kidney disease, current smoker, immunosuppressive disease or immunosuppressive treatment, cardiovascular disease, hypertension, sickle cell disease, neurodevelopmental disorders, active cancer, and patients >60 years of age.
• In February 2023, the FDA updated the EUA by removing the need for a positive COVID-19 viral test to prescribe the medication.

Paxlovid is NOT authorized for:

• Initiation of treatment for patients requiring hospitalization
• Pre-exposure or post-exposure prophylaxis for prevention of COVID-19
• Use longer than 5 consecutive days